LUPIN
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Lupin Announces Presentation Of Phase 1 Data On Lnp3693 (Sting Agonist)
Oct 13 (Reuters) - Lupin Ltd LUPN.NS:
ANNOUNCES PRESENTATION OF PHASE 1 DATA ON LNP3693 (STING AGONIST)
Source text: ID:nBSEbC38QP
Further company coverage: LUPN.NS
(([email protected];))
Oct 13 (Reuters) - Lupin Ltd LUPN.NS:
ANNOUNCES PRESENTATION OF PHASE 1 DATA ON LNP3693 (STING AGONIST)
Source text: ID:nBSEbC38QP
Further company coverage: LUPN.NS
(([email protected];))
Lupin Says U.S FDA Has Conducted A Pre-Approval Inspection At Manufacturing Facility Located In Somerset, New Jersey, USA
Oct 11 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN: U.S. FDA HAS CONDUCTED A PRE-APPROVAL INSPECTION AT OUR MANUFACTURING FACILITY LOCATED IN SOMERSET, NEW JERSEY, USA
LUPIN: THE U.S. FDA INSPECTION WAS CONDUCTED FROM SEPTEMBER 29 TO OCTOBER 10, 2025 AND CONCLUDED WITH ONE OBSERVATION
Further company coverage: LUPN.NS
(([email protected];))
Oct 11 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN: U.S. FDA HAS CONDUCTED A PRE-APPROVAL INSPECTION AT OUR MANUFACTURING FACILITY LOCATED IN SOMERSET, NEW JERSEY, USA
LUPIN: THE U.S. FDA INSPECTION WAS CONDUCTED FROM SEPTEMBER 29 TO OCTOBER 10, 2025 AND CONCLUDED WITH ONE OBSERVATION
Further company coverage: LUPN.NS
(([email protected];))
India's Lupin gains on plans for new U.S. manufacturing unit
** Lupin LUPN.NS rises 3.6% to 1,973.70 rupees; set to snap four-session losing streak
** Pharmaceuticals co plans to build new manufacturing facility in Coral Springs, Florida
** Projected cumulative investment of $250 mln in new facility for R&D, infra and capital expenditures over five years
** New site will have capacity to accommodate production of more than 25 critical respiratory medicines
** Co to get tax credits, incentives from Florida
** Citi says U.S. investment may help co smoothly navigate geopolitical risks like tariffs
** YTD, LUPN falls ~16%
(Reporting by Vijay Malkar)
(([email protected];))
** Lupin LUPN.NS rises 3.6% to 1,973.70 rupees; set to snap four-session losing streak
** Pharmaceuticals co plans to build new manufacturing facility in Coral Springs, Florida
** Projected cumulative investment of $250 mln in new facility for R&D, infra and capital expenditures over five years
** New site will have capacity to accommodate production of more than 25 critical respiratory medicines
** Co to get tax credits, incentives from Florida
** Citi says U.S. investment may help co smoothly navigate geopolitical risks like tariffs
** YTD, LUPN falls ~16%
(Reporting by Vijay Malkar)
(([email protected];))
India's Lupin falls after US FDA flags compliance issues at facility
** Shares of Lupin LUPN.NS fall 2% to 1,934 rupees
** The pharmaceutical co's Pithampur Unit-2 is classified as OAI (Official Action Indicated) following the US FDA's inspection in July 2025 and received four Form 483 observations
** Classification implies that the site will not receive any new approvals until the observations are addressed- Nomura
** The observations were primarily related to sterile operations at the Pithampur Unit-2, which produces oral solids and ophthalmic products - Nomura
** We think the observations were largely for the ophthalmic product manufacturing - Nomura
** Stock rated "buy" on avg by analysts covering it; median PT is 2243 rupees - as per LSEG data
** Stock down 18% YTD
(Reporting by Komal Salecha)
(([email protected];))
** Shares of Lupin LUPN.NS fall 2% to 1,934 rupees
** The pharmaceutical co's Pithampur Unit-2 is classified as OAI (Official Action Indicated) following the US FDA's inspection in July 2025 and received four Form 483 observations
** Classification implies that the site will not receive any new approvals until the observations are addressed- Nomura
** The observations were primarily related to sterile operations at the Pithampur Unit-2, which produces oral solids and ophthalmic products - Nomura
** We think the observations were largely for the ophthalmic product manufacturing - Nomura
** Stock rated "buy" on avg by analysts covering it; median PT is 2243 rupees - as per LSEG data
** Stock down 18% YTD
(Reporting by Komal Salecha)
(([email protected];))
India's Lupin jumps after US FDA nod for Rivaroxaban's oral suspension
** Shares of Lupin LUPN.NS jump 4% to 1,986.50 rupees, top gainer on pharma index .NIPHARM, which is up 1%
** Co receives U.S. Food and Drug Administration approval for its generic Rivaroxaban for oral suspension
** The drug, which helps treat blood clots and prevent them from coming back in children, will be manufactured at its unit in Maharashtra
** Drug's oral suspension had estimated annual sales of $11 million in the U.S.
** 35 analysts have a "buy" rating on avg; median PT is 2,243 rupees - data compiled by LSEG
** YTD, LUPN down ~16% YTD vs Nifty pharma's 7.4% decline
(Reporting by Urvi Dugar)
(([email protected];))
** Shares of Lupin LUPN.NS jump 4% to 1,986.50 rupees, top gainer on pharma index .NIPHARM, which is up 1%
** Co receives U.S. Food and Drug Administration approval for its generic Rivaroxaban for oral suspension
** The drug, which helps treat blood clots and prevent them from coming back in children, will be manufactured at its unit in Maharashtra
** Drug's oral suspension had estimated annual sales of $11 million in the U.S.
** 35 analysts have a "buy" rating on avg; median PT is 2,243 rupees - data compiled by LSEG
** YTD, LUPN down ~16% YTD vs Nifty pharma's 7.4% decline
(Reporting by Urvi Dugar)
(([email protected];))
Lupin Receives U.S. FDA Approval For Rivaroxaban Oral Suspension
Sept 30 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - RECEIVES U.S. FDA APPROVAL FOR RIVAROXABAN ORAL SUSPENSION
Source text: ID:nBSE1jRDl1
Further company coverage: LUPN.NS
(([email protected];))
Sept 30 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - RECEIVES U.S. FDA APPROVAL FOR RIVAROXABAN ORAL SUSPENSION
Source text: ID:nBSE1jRDl1
Further company coverage: LUPN.NS
(([email protected];))
India's Lupin rises as Investec upgrades to 'buy'
** Shares of Lupin LUPN.NS rise 2.2% to 2,031 rupees
** Stock top gainer in Nifty Pharma index.NIPHARM, which is up 0.3%
** Investec upgrades pharma co to "Buy" from "Hold"; raise PT to 2,265 rupees from 2,100, implying 14% upside from last close
** Sees Lupin well-placed to benefit from India's emerging anti-diabetes drug (GLP-1) opportunity, citing its strong positioning in diabetes, cardiac, diagnostics, and consumer segments
** Says consistent execution in complex generics and recent momentum in U.S. business, aided by favorable macro factors
** Highlights niche injectables and potential upside from biosimilars and inhalation products
** LUPN rated "Buy" by 35 analysts on average; median target price is 2,243.5 rupees – data compiled by LSEG
** YTD: LUPN down 13.3% vs Nifty Pharama down 4.8%
(Reporting by Rudra Pratap Singh in Bengaluru)
** Shares of Lupin LUPN.NS rise 2.2% to 2,031 rupees
** Stock top gainer in Nifty Pharma index.NIPHARM, which is up 0.3%
** Investec upgrades pharma co to "Buy" from "Hold"; raise PT to 2,265 rupees from 2,100, implying 14% upside from last close
** Sees Lupin well-placed to benefit from India's emerging anti-diabetes drug (GLP-1) opportunity, citing its strong positioning in diabetes, cardiac, diagnostics, and consumer segments
** Says consistent execution in complex generics and recent momentum in U.S. business, aided by favorable macro factors
** Highlights niche injectables and potential upside from biosimilars and inhalation products
** LUPN rated "Buy" by 35 analysts on average; median target price is 2,243.5 rupees – data compiled by LSEG
** YTD: LUPN down 13.3% vs Nifty Pharama down 4.8%
(Reporting by Rudra Pratap Singh in Bengaluru)
Lupin Gets U.S. FDA Nod for Risperidone LAI With 180-Day CGT Exclusivity
Sept 10 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN RECEIVES U.S. FDA APPROVAL FOR RISPERIDONE LONG-ACTING INJECTABLE, WITH 180-DAY CGT EXCLUSIVITY, THE FIRST PRODUCT FROM ITS NANOMI'S LONG-ACTING INJECTABLE PLATFORM
Source text: ID:nPre4jhhwa
Further company coverage: LUPN.NS
(([email protected];))
Sept 10 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN RECEIVES U.S. FDA APPROVAL FOR RISPERIDONE LONG-ACTING INJECTABLE, WITH 180-DAY CGT EXCLUSIVITY, THE FIRST PRODUCT FROM ITS NANOMI'S LONG-ACTING INJECTABLE PLATFORM
Source text: ID:nPre4jhhwa
Further company coverage: LUPN.NS
(([email protected];))
India's Lupin rises after US FDA nod for Risperidone injectable
** Shares of Lupin Ltd LUPN.NS rise as much as 2.5% to 1,937.4 rupees
** Pharma co gets United States Food and Drug Administration (U.S. FDA) approval for its long-acting injectable drug Risperidone used to treat schizophrenia, bipolar I disorder
** Stock hits highest level in over a week
** Mean rating of stock is 'buy'; their median PT is 2,237 rupees - data compiled by LSEG
** Day's gains trims YTD losses to nearly 20%
(Reporting by Meenakshi Maidas in Bengaluru)
(([email protected];))
** Shares of Lupin Ltd LUPN.NS rise as much as 2.5% to 1,937.4 rupees
** Pharma co gets United States Food and Drug Administration (U.S. FDA) approval for its long-acting injectable drug Risperidone used to treat schizophrenia, bipolar I disorder
** Stock hits highest level in over a week
** Mean rating of stock is 'buy'; their median PT is 2,237 rupees - data compiled by LSEG
** Day's gains trims YTD losses to nearly 20%
(Reporting by Meenakshi Maidas in Bengaluru)
(([email protected];))
Does a common heart attack pill help everyone? Studies disagree
In two large studies of heart attack survivors, beta-blocker drugs benefited those with mildly impaired heart function
Contradictory trial results seen in patients without heart dysfunction
More data on beta-blockers in patients with normally functioning hearts expected in November
By Nancy Lapid
Aug 30 (Reuters) - A decades-old pill remains helpful for heart attack patients even with modern treatments that can prevent lasting damage to heart muscle, two large trials have shown.
Still unclear is whether all patients, or only some, benefit from so-called beta-blocker drugs, which are typically prescribed to everyone after a heart attack.
Two sharply contradictory reports were presented on Saturday at a large cardiology meeting in Madrid and published in The New England Journal of Medicine.
“It is not unusual for trials to yield different results,” said Dr. Borja Ibanez of Centro Nacional de Investigaciones Cardiovasculares Carlos III in Madrid, who led one of the trials.
“Somewhat uncommon is to see two trials with apparently divergent findings presented on the same day.”
Most important, Ibanez said, is the finding both teams agree on, which is that beta-blockers reduce the combined risk of another heart attack, heart failure, or death in patients without heart failure but with mildly impaired heart function.
The question is whether the pills are beneficial or useless for those with normally functioning hearts, who account for about 80% of patients after a first heart attack.
Beta-blocker manufacturers include Mylan, Novartis NOVN.S, Pfizer PFE.N, Abbott, Teva Pharmaceutical Industries TEVA.TA, Amneal Pharmaceuticals AMRX.O, Sun Pharmaceutical Industries SUN.NS, Lupin, ANI Pharmaceuticals ANIP.O, and Eagle Pharmaceuticals EGRX.PK.
The drugs work by inhibiting the hormones epinephrine and norepinephrine, thereby lowering heart rate and blood pressure, decreasing the workload on the heart and reducing its oxygen demand.
Both new trials involved heart attack survivors whose hearts were still contracting normally, that is, the left ventricle was pumping out at least 40% of its blood with each beat. Both trials followed patients for roughly 3.5 years.
Among 5,574 volunteers in the BETAMI–DANBLOCK study from Norway and Denmark, the drugs showed a clear benefit. Patients randomly assigned to receive beta-blockers had a 15% lower risk of death or major adverse cardiovascular event, particularly a repeat heart attack, compared to patients not taking these pills, investigators found.
But among the 8,438 participants in the REBOOT trial conducted in Italy and Spain, beta-blockers had no effect on the incidence of death from any cause, a repeat heart attack, or hospitalization for heart failure, according to a separate report.
Some of the difference may be due to the fact that patients didn't all receive the same beta-blockers, and the Scandinavian patients might have been more prone to adverse events because they were slightly older than patients in Spain and Italy and more of them had mild heart dysfunction, said Dr. Dan Atar of the University of Oslo, who led one of the trials.
Among female participants in REBOOT, those taking beta-blockers - particularly those with good heart function receiving higher doses – had more adverse outcomes than women not taking the drugs, researchers reported in the European Heart Journal.
In REBOOT, researchers did see a lower rate of new heart attacks, heart failure, or death with beta-blocker use by patients with mildly reduced heart function, as indicated by a left ventricular “ejection fraction” between 40% and 49%.
The effect in this subgroup was confirmed in an analysis of data pooled from REBOOT, BETAMI–DANBLOCK, and a Japanese trial, according to a report published in The Lancet.
The message for cardiologists, Ibanez said, is “We can now state with confidence that beta-blockers are beneficial” in patients with mildly impaired heart function, and “there remains reasonable uncertainty about their benefit” in patients with normally functioning hearts.
Atar said an analysis looking specifically at beta-blocker use by patients with normal heart function will be presented at a U.S. cardiology meeting in November.
(Reporting by Nancy Lapid; editing by Caroline Humer and Diane Craft)
(([email protected];))
In two large studies of heart attack survivors, beta-blocker drugs benefited those with mildly impaired heart function
Contradictory trial results seen in patients without heart dysfunction
More data on beta-blockers in patients with normally functioning hearts expected in November
By Nancy Lapid
Aug 30 (Reuters) - A decades-old pill remains helpful for heart attack patients even with modern treatments that can prevent lasting damage to heart muscle, two large trials have shown.
Still unclear is whether all patients, or only some, benefit from so-called beta-blocker drugs, which are typically prescribed to everyone after a heart attack.
Two sharply contradictory reports were presented on Saturday at a large cardiology meeting in Madrid and published in The New England Journal of Medicine.
“It is not unusual for trials to yield different results,” said Dr. Borja Ibanez of Centro Nacional de Investigaciones Cardiovasculares Carlos III in Madrid, who led one of the trials.
“Somewhat uncommon is to see two trials with apparently divergent findings presented on the same day.”
Most important, Ibanez said, is the finding both teams agree on, which is that beta-blockers reduce the combined risk of another heart attack, heart failure, or death in patients without heart failure but with mildly impaired heart function.
The question is whether the pills are beneficial or useless for those with normally functioning hearts, who account for about 80% of patients after a first heart attack.
Beta-blocker manufacturers include Mylan, Novartis NOVN.S, Pfizer PFE.N, Abbott, Teva Pharmaceutical Industries TEVA.TA, Amneal Pharmaceuticals AMRX.O, Sun Pharmaceutical Industries SUN.NS, Lupin, ANI Pharmaceuticals ANIP.O, and Eagle Pharmaceuticals EGRX.PK.
The drugs work by inhibiting the hormones epinephrine and norepinephrine, thereby lowering heart rate and blood pressure, decreasing the workload on the heart and reducing its oxygen demand.
Both new trials involved heart attack survivors whose hearts were still contracting normally, that is, the left ventricle was pumping out at least 40% of its blood with each beat. Both trials followed patients for roughly 3.5 years.
Among 5,574 volunteers in the BETAMI–DANBLOCK study from Norway and Denmark, the drugs showed a clear benefit. Patients randomly assigned to receive beta-blockers had a 15% lower risk of death or major adverse cardiovascular event, particularly a repeat heart attack, compared to patients not taking these pills, investigators found.
But among the 8,438 participants in the REBOOT trial conducted in Italy and Spain, beta-blockers had no effect on the incidence of death from any cause, a repeat heart attack, or hospitalization for heart failure, according to a separate report.
Some of the difference may be due to the fact that patients didn't all receive the same beta-blockers, and the Scandinavian patients might have been more prone to adverse events because they were slightly older than patients in Spain and Italy and more of them had mild heart dysfunction, said Dr. Dan Atar of the University of Oslo, who led one of the trials.
Among female participants in REBOOT, those taking beta-blockers - particularly those with good heart function receiving higher doses – had more adverse outcomes than women not taking the drugs, researchers reported in the European Heart Journal.
In REBOOT, researchers did see a lower rate of new heart attacks, heart failure, or death with beta-blocker use by patients with mildly reduced heart function, as indicated by a left ventricular “ejection fraction” between 40% and 49%.
The effect in this subgroup was confirmed in an analysis of data pooled from REBOOT, BETAMI–DANBLOCK, and a Japanese trial, according to a report published in The Lancet.
The message for cardiologists, Ibanez said, is “We can now state with confidence that beta-blockers are beneficial” in patients with mildly impaired heart function, and “there remains reasonable uncertainty about their benefit” in patients with normally functioning hearts.
Atar said an analysis looking specifically at beta-blocker use by patients with normal heart function will be presented at a U.S. cardiology meeting in November.
(Reporting by Nancy Lapid; editing by Caroline Humer and Diane Craft)
(([email protected];))
ARS Pharmaceuticals Inc. Receives Paragraph IV Notice from Lupin, Plans to Defend Patents on Neffy Nasal Spray
On August 13, 2025, ARS Pharmaceuticals Inc. announced that it received a Paragraph IV certification notice from Lupin Inc. Lupin has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), seeking approval to manufacture and sell a generic version of ARS Pharmaceuticals' product, neffy©2 mg (epinephrine nasal spray), before the expiration of several U.S. patents. The patents in question are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. ARS Pharmaceuticals plans to vigorously defend its intellectual property rights and intends to file a patent infringement lawsuit against Lupin.
On August 13, 2025, ARS Pharmaceuticals Inc. announced that it received a Paragraph IV certification notice from Lupin Inc. Lupin has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), seeking approval to manufacture and sell a generic version of ARS Pharmaceuticals' product, neffy©2 mg (epinephrine nasal spray), before the expiration of several U.S. patents. The patents in question are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. ARS Pharmaceuticals plans to vigorously defend its intellectual property rights and intends to file a patent infringement lawsuit against Lupin.
Catalyst Pharmaceuticals Settles Patent Litigation with Lupin, Grants License for Generic FIRDAPSE Marketing Starting February 2035
Catalyst Pharmaceuticals Inc. has announced a settlement agreement with Lupin Ltd and Lupin Pharmaceuticals, Inc. regarding the patent litigation over FIRDAPSE® (amifampridine) 10 mg tablets. Under the terms of the agreement, Lupin will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending approval from the U.S. Food and Drug Administration. The agreement will lead to the termination of all ongoing patent litigation between Catalyst/SERB and Lupin in the U.S. District Court for the District of New Jersey. Similar litigation had previously been settled with Teva Pharmaceuticals and Inventia Life Science Pty Ltd, but litigation against Hetero regarding FIRDAPSE's Orange Book-listed patents remains ongoing. The confidential settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Catalyst Pharmaceuticals Inc. has announced a settlement agreement with Lupin Ltd and Lupin Pharmaceuticals, Inc. regarding the patent litigation over FIRDAPSE® (amifampridine) 10 mg tablets. Under the terms of the agreement, Lupin will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending approval from the U.S. Food and Drug Administration. The agreement will lead to the termination of all ongoing patent litigation between Catalyst/SERB and Lupin in the U.S. District Court for the District of New Jersey. Similar litigation had previously been settled with Teva Pharmaceuticals and Inventia Life Science Pty Ltd, but litigation against Hetero regarding FIRDAPSE's Orange Book-listed patents remains ongoing. The confidential settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Lupin Launches Bosentan Tablets For Oral Suspension In United States With 180-Day Exclusivity
Aug 20 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN - LAUNCHES BOSENTAN TABLETS FOR ORAL SUSPENSION IN UNITED STATES WITH 180-DAY EXCLUSIVITY
Further company coverage: LUPN.NS
(([email protected];))
Aug 20 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN - LAUNCHES BOSENTAN TABLETS FOR ORAL SUSPENSION IN UNITED STATES WITH 180-DAY EXCLUSIVITY
Further company coverage: LUPN.NS
(([email protected];))
Lupin And Zentiva Sign Agreement For Certolizumab
July 9 (Reuters) - Lupin Ltd LUPN.NS:
CO AND ZENTIVA SIGN AGREEMENT FOR CERTOLIZUMAB
BOTH PARTIES WILL INVEST IN DEVELOPMENT OF NEW BIOSIMILAR
TO RECEIVE INITIAL PAYMENT OF USD 10 MILLION, MILESTONE PAYMENTS UP TO USD 50 MILLION
Source text: ID:nNSE2vSMv7
Further company coverage: LUPN.NS
(([email protected];;))
July 9 (Reuters) - Lupin Ltd LUPN.NS:
CO AND ZENTIVA SIGN AGREEMENT FOR CERTOLIZUMAB
BOTH PARTIES WILL INVEST IN DEVELOPMENT OF NEW BIOSIMILAR
TO RECEIVE INITIAL PAYMENT OF USD 10 MILLION, MILESTONE PAYMENTS UP TO USD 50 MILLION
Source text: ID:nNSE2vSMv7
Further company coverage: LUPN.NS
(([email protected];;))
Lupin Announces Strategic Carve-Out Of Lupinlife Consumer Healthcare
July 1 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - ANNOUNCES STRATEGIC CARVE-OUT OF LUPINLIFE CONSUMER HEALTHCARE
LUPIN LTD - ANIL KAUSHAL APPOINTED CEO OF LUPINLIFE CONSUMER HEALTHCARE
Source text: ID:nBSE4sTC3W
Further company coverage: LUPN.NS
(([email protected];;))
July 1 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - ANNOUNCES STRATEGIC CARVE-OUT OF LUPINLIFE CONSUMER HEALTHCARE
LUPIN LTD - ANIL KAUSHAL APPOINTED CEO OF LUPINLIFE CONSUMER HEALTHCARE
Source text: ID:nBSE4sTC3W
Further company coverage: LUPN.NS
(([email protected];;))
Lupin Executes Business Transfer Agreement For Transfer Of OTC Business To Lupinlife Consumer
June 30 (Reuters) - Lupin Ltd LUPN.NS:
EXECUTED BUSINESS TRANSFER AGREEMENT FOR TRANSFER OF OTC BUSINESS TO LUPINLIFE CONSUMER
TRANSFER OF OTC BUSINESS EFFECTIVE FROM JULY 01, 2025
Source text: [ID:]
Further company coverage: LUPN.NS
(([email protected];;))
June 30 (Reuters) - Lupin Ltd LUPN.NS:
EXECUTED BUSINESS TRANSFER AGREEMENT FOR TRANSFER OF OTC BUSINESS TO LUPINLIFE CONSUMER
TRANSFER OF OTC BUSINESS EFFECTIVE FROM JULY 01, 2025
Source text: [ID:]
Further company coverage: LUPN.NS
(([email protected];;))
Lilly to launch Mounjaro pen in India as Novo rivalry heats up in mega market
Updates paragraph 1, adds details on Novo Nordisk and Eli Lilly
June 26 (Reuters) - India's drug regulator on Thursday approved the launch of pre-filled injector pens of Eli Lilly's LLY.N blockbuster weight-loss drug, Mounjaro, giving the company more options to compete with rival Novo Nordisk's NOVOb.CO recently launched Wegovy.
India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.
Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:
NOVO NORDISK
The Danish drugmaker launched its blockbuster weight-loss drug Wegovy in India on June 24, three months after Eli Lilly began marketing its rival product Mounjaro.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply.
GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.
ELI LILLY
Lilly started selling Mounjaro in India in late March for diabetes and obesity, beating rival Novo to the market. The doses available were 2.5 mg and 5 mg vials.
On Thursday, Mounjaro KwikPen - for once-weekly use - was approved by the Central Drugs Standard Control Organization for six dose strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg.
SUN PHARMA
Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.
The drugmaker said earlier this month it expects to launch the drug in the next four to five years.
BIOCON
Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.
ZYDUS LIFESCIENCES
India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.
CIPLA
Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.
Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.
DR. REDDY'S
India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.
LUPIN
India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.
NATCO, MANKIND PHARMA, AUROBINDO PHARMA
Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.
Reuters was not able to independently verify the reports.
(Reporting by Mariam Sunny and Puyaan Singh in Bengaluru; Editing by Maju Samuel)
(([email protected];))
Updates paragraph 1, adds details on Novo Nordisk and Eli Lilly
June 26 (Reuters) - India's drug regulator on Thursday approved the launch of pre-filled injector pens of Eli Lilly's LLY.N blockbuster weight-loss drug, Mounjaro, giving the company more options to compete with rival Novo Nordisk's NOVOb.CO recently launched Wegovy.
India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.
Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:
NOVO NORDISK
The Danish drugmaker launched its blockbuster weight-loss drug Wegovy in India on June 24, three months after Eli Lilly began marketing its rival product Mounjaro.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply.
GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.
ELI LILLY
Lilly started selling Mounjaro in India in late March for diabetes and obesity, beating rival Novo to the market. The doses available were 2.5 mg and 5 mg vials.
On Thursday, Mounjaro KwikPen - for once-weekly use - was approved by the Central Drugs Standard Control Organization for six dose strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg.
SUN PHARMA
Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.
The drugmaker said earlier this month it expects to launch the drug in the next four to five years.
BIOCON
Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.
ZYDUS LIFESCIENCES
India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.
CIPLA
Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.
Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.
DR. REDDY'S
India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.
LUPIN
India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.
NATCO, MANKIND PHARMA, AUROBINDO PHARMA
Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.
Reuters was not able to independently verify the reports.
(Reporting by Mariam Sunny and Puyaan Singh in Bengaluru; Editing by Maju Samuel)
(([email protected];))
Lupin, Sino Universal Pharmaceuticals Sign License, Supply Agreement For Tiotropium DPI In China
June 16 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN - CO AND SINO UNIVERSAL PHARMACEUTICALS SIGN LICENSE AND SUPPLY AGREEMENT FOR TIOTROPIUM DPI IN CHINA
LUPIN- LUPIN, SINO UNIVERSAL PHARMA SIGN LICENSE AND SUPPLY AGREEMENT FOR TIOTROPIUM DPI IN CHINA
LUPIN- LUPIN WILL BE THE MARKETING AUTHORIZATION HOLDER AND RESPONSIBLE FOR MANUFACTURING
Further company coverage: LUPN.NS
(([email protected];))
June 16 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN - CO AND SINO UNIVERSAL PHARMACEUTICALS SIGN LICENSE AND SUPPLY AGREEMENT FOR TIOTROPIUM DPI IN CHINA
LUPIN- LUPIN, SINO UNIVERSAL PHARMA SIGN LICENSE AND SUPPLY AGREEMENT FOR TIOTROPIUM DPI IN CHINA
LUPIN- LUPIN WILL BE THE MARKETING AUTHORIZATION HOLDER AND RESPONSIBLE FOR MANUFACTURING
Further company coverage: LUPN.NS
(([email protected];))
Harmony Biosciences Secures Patent Position with Settlement in WAKIX® Generic Litigation
Harmony Biosciences Holdings Inc. has announced a settlement agreement with Lupin Limited, resolving patent infringement litigation over Lupin's attempt to produce a generic version of WAKIX® (pitolisant hydrochloride). Under the agreement, Lupin will be able to launch its generic product no earlier than January 2030, or potentially in July 2030 with pediatric exclusivity. Additionally, the U.S. Patent Office Patent Trial and Appeal Board recently upheld the validity of Harmony's exclusively licensed polymorph patent for pitolisant hydrochloride by declining to initiate an Ex Parte Reexamination. Harmony continues to defend its intellectual property, reinforcing its patent portfolio's strength, which protects its innovations in sleep/wake therapeutics.
Harmony Biosciences Holdings Inc. has announced a settlement agreement with Lupin Limited, resolving patent infringement litigation over Lupin's attempt to produce a generic version of WAKIX® (pitolisant hydrochloride). Under the agreement, Lupin will be able to launch its generic product no earlier than January 2030, or potentially in July 2030 with pediatric exclusivity. Additionally, the U.S. Patent Office Patent Trial and Appeal Board recently upheld the validity of Harmony's exclusively licensed polymorph patent for pitolisant hydrochloride by declining to initiate an Ex Parte Reexamination. Harmony continues to defend its intellectual property, reinforcing its patent portfolio's strength, which protects its innovations in sleep/wake therapeutics.
Lupin Honeywell Move Forward Jointly With Plans For HFO Technology In Inhalers
May 20 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN AND HONEYWELL MOVE FORWARD JOINTLY WITH PLANS FOR HFO TECHNOLOGY IN INHALERS
Further company coverage: LUPN.NS
(([email protected];;))
May 20 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN AND HONEYWELL MOVE FORWARD JOINTLY WITH PLANS FOR HFO TECHNOLOGY IN INHALERS
Further company coverage: LUPN.NS
(([email protected];;))
Lupin Receives U.S. FDA Approval For Raltegravir Tablets USP, 600 Mg
May 8 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES U.S. FDA APPROVAL FOR RALTEGRAVIR TABLETS USP, 600 MG
ELIGIBLE FOR 180-DAY GENERIC EXCLUSIVITY FOR RALTEGRAVIR
Source text: ID:nBSE2fS4Wn
Further company coverage: LUPN.NS
(([email protected];;))
May 8 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES U.S. FDA APPROVAL FOR RALTEGRAVIR TABLETS USP, 600 MG
ELIGIBLE FOR 180-DAY GENERIC EXCLUSIVITY FOR RALTEGRAVIR
Source text: ID:nBSE2fS4Wn
Further company coverage: LUPN.NS
(([email protected];;))
Lupin Receives Approval From U.S. FDA For Tolvaptan Tablets
April 24 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES APPROVAL FROM U.S. FDA FOR TOLVAPTAN TABLETS
Source text: [ID:]
Further company coverage: LUPN.NS
(([email protected];;))
April 24 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES APPROVAL FROM U.S. FDA FOR TOLVAPTAN TABLETS
Source text: [ID:]
Further company coverage: LUPN.NS
(([email protected];;))
Lupin Receives EIR From US FDA For Nagpur Facility
April 17 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES EIR FROM US FDA FOR NAGPUR FACILITY
EIR ISSUED AFTER INSPECTION FROM JUNE 10 TO JUNE 13, 2024
Source text: ID:nBSE4mtxpR
Further company coverage: LUPN.NS
(([email protected];;))
April 17 (Reuters) - Lupin Ltd LUPN.NS:
RECEIVES EIR FROM US FDA FOR NAGPUR FACILITY
EIR ISSUED AFTER INSPECTION FROM JUNE 10 TO JUNE 13, 2024
Source text: ID:nBSE4mtxpR
Further company coverage: LUPN.NS
(([email protected];;))
India's Zydus Life and Lupin fall on losing US patent case for bladder disorder drug
** India's Zydus Lifesciences ZYDU.NS and Lupin LUPN.NS shed 6.6% and 3.8%, respectively
** Drugmakers lose patent litigation case in US for mirabegron, a generic version of Astellas Pharma's 4503.T bladder disorder drug Myrbetriq
** ZYDU and LUPN top losers on pharma index .NIPHARM which is down 0.2%
** It is a negative development for Zydus and Lupin as loss in litigation implies that they have to withdraw the drug from the market and could see some financial penalty, says Equirus
** Brokerage estimates $35 mln in quarterly sales from mirabegron for ZYDU and $25-30 mln for LUPN
** YTD, ZYDU drops ~15% while LUPN falls ~18%; pharma index down 11%
(Reporting by Kashish Tandon in Bengaluru)
** India's Zydus Lifesciences ZYDU.NS and Lupin LUPN.NS shed 6.6% and 3.8%, respectively
** Drugmakers lose patent litigation case in US for mirabegron, a generic version of Astellas Pharma's 4503.T bladder disorder drug Myrbetriq
** ZYDU and LUPN top losers on pharma index .NIPHARM which is down 0.2%
** It is a negative development for Zydus and Lupin as loss in litigation implies that they have to withdraw the drug from the market and could see some financial penalty, says Equirus
** Brokerage estimates $35 mln in quarterly sales from mirabegron for ZYDU and $25-30 mln for LUPN
** YTD, ZYDU drops ~15% while LUPN falls ~18%; pharma index down 11%
(Reporting by Kashish Tandon in Bengaluru)
UPDATE 5-Global pharma shares plunge as Trump doubles down on tariff threat
US drugmakers' shares drop 3% to 6% premarket
European, Indian healthcare stocks drag down broader indexes
Trump aims to shift pharma manufacturing to US, but analysts doubtful
Adds analyst comments in paragraphs 11-12, updates share moves throughout
By Manas Mishra and Ananta Agarwal
April 9 (Reuters) - Global drugmakers' stocks dropped across the board after U.S. President Donald Trump reiterated plans for a "major" tariff on pharmaceutical imports, threatening an interwoven global supply chain, and as his country-specific reciprocal tariffs took effect, leading to more pain in global markets.
Pharmaceutical imports were initially exempt from Trump's first set of reciprocal tariffs last week — but his administration has since indicated that levies on the sector, which in the past has been excluded from such actions, are coming.
The U.S. president has said the tariffs will incentivize drug companies to move operations to the United States. However, analysts and companies have raised concerns about the difficulty in setting up manufacturing in the country.
Shares of major U.S. drugmakers Amgen AMGN.O, AbbVie ABBV.N, Pfizer PFE.N, Merck MRK.N and Eli Lilly LLY.N fell between 3% and 6% in premarket trading.
In Europe, a basket of healthcare stocks .SXDP fell 5% to its lowest since October 2022, leading losses among sectoral indexes on the region-wide STOXX 600 .STOXX, which was down 3.3% at 1013 GMT. The index was heading for its biggest one-day drop since March 2020.
Trump had also threatened the duties on Friday after his first set of "reciprocal" tariffs exempted pharma products. Trump has not said when and by how much he plans to raise levies on pharma imports.
"While the details are scant, we are strongly opposed to tariffs on any pharmaceuticals — these will likely do little to shift manufacturing back to the U.S.," said BMO Capital Markets analyst Evan Seigerman.
"Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes. These current tariffs are being pursued under emergency powers, which at worse will last until the end of the current administration and could end sooner with an act of Congress."
Seigerman also pointed to concerns over recent layoffs at the U.S. Food and Drug Administration, saying the worries were now compounded by the "real talk" of pharma tariffs.
ADDITIONAL COSTS, LONG WAIT FOR PRODUCTION
Europe and the U.S. have interconnected supply chains for medicines. The United States depends on medicines partly produced in Europe that bring in hundreds of billions of dollars in revenue.
Bernstein analyst Courtney Breen wrote in a note that her worst-case scenario assumes tariffs could be steep, leading to about $53 billion in additional costs paid for pharmaceutical imports.
If companies did choose to bring new manufacturing to the United States, Breen expects additional spend of $2 billion for each new "green field" site and a five-year runway to production.
EU medical and pharmaceutical product exports to the U.S. totaled about 90 billion euros ($97 billion) in 2023, according to latest Eurostat data.
Shares of AstraZeneca AZN.L, GSK GSK.L, Roche ROG.S, Sanofi SASY.PA and Novartis NOVN.S fell between 5% and 6.5% in Europe. Meanwhile, Indian pharmaceutical stocks .NIPHARM closed nearly 2% lower, dragging down the benchmark Nifty 50 .NSEI by 0.6%.
IPCA Laboratories IPCA.NS, Glenmark Pharma GLEN.NS and Biocon BION.NS were the top losers by percentage on the pharma index in Mumbai, ending the trading session between 4% and 5.5% lower.
India's pharma exports to the U.S. mostly comprise generics, or cheaper versions of popular drugs. The United States accounts for a third of India's overall pharma exports.
European pharma companies hit by looming tariff threat https://reut.rs/3Efihqg
BREAKINGVIEWS-Big Pharma has partial immunity from Trump tariffs nL5N3QM18T
(Reporting by Kashish Tandon, Ananta Agarwal and Manas Mishra in Bengaluru and Anna Pruchnicka in Gdansk; Editing by Savio D'Souza, Mrigank Dhaniwala and Shounak Dasgupta)
US drugmakers' shares drop 3% to 6% premarket
European, Indian healthcare stocks drag down broader indexes
Trump aims to shift pharma manufacturing to US, but analysts doubtful
Adds analyst comments in paragraphs 11-12, updates share moves throughout
By Manas Mishra and Ananta Agarwal
April 9 (Reuters) - Global drugmakers' stocks dropped across the board after U.S. President Donald Trump reiterated plans for a "major" tariff on pharmaceutical imports, threatening an interwoven global supply chain, and as his country-specific reciprocal tariffs took effect, leading to more pain in global markets.
Pharmaceutical imports were initially exempt from Trump's first set of reciprocal tariffs last week — but his administration has since indicated that levies on the sector, which in the past has been excluded from such actions, are coming.
The U.S. president has said the tariffs will incentivize drug companies to move operations to the United States. However, analysts and companies have raised concerns about the difficulty in setting up manufacturing in the country.
Shares of major U.S. drugmakers Amgen AMGN.O, AbbVie ABBV.N, Pfizer PFE.N, Merck MRK.N and Eli Lilly LLY.N fell between 3% and 6% in premarket trading.
In Europe, a basket of healthcare stocks .SXDP fell 5% to its lowest since October 2022, leading losses among sectoral indexes on the region-wide STOXX 600 .STOXX, which was down 3.3% at 1013 GMT. The index was heading for its biggest one-day drop since March 2020.
Trump had also threatened the duties on Friday after his first set of "reciprocal" tariffs exempted pharma products. Trump has not said when and by how much he plans to raise levies on pharma imports.
"While the details are scant, we are strongly opposed to tariffs on any pharmaceuticals — these will likely do little to shift manufacturing back to the U.S.," said BMO Capital Markets analyst Evan Seigerman.
"Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes. These current tariffs are being pursued under emergency powers, which at worse will last until the end of the current administration and could end sooner with an act of Congress."
Seigerman also pointed to concerns over recent layoffs at the U.S. Food and Drug Administration, saying the worries were now compounded by the "real talk" of pharma tariffs.
ADDITIONAL COSTS, LONG WAIT FOR PRODUCTION
Europe and the U.S. have interconnected supply chains for medicines. The United States depends on medicines partly produced in Europe that bring in hundreds of billions of dollars in revenue.
Bernstein analyst Courtney Breen wrote in a note that her worst-case scenario assumes tariffs could be steep, leading to about $53 billion in additional costs paid for pharmaceutical imports.
If companies did choose to bring new manufacturing to the United States, Breen expects additional spend of $2 billion for each new "green field" site and a five-year runway to production.
EU medical and pharmaceutical product exports to the U.S. totaled about 90 billion euros ($97 billion) in 2023, according to latest Eurostat data.
Shares of AstraZeneca AZN.L, GSK GSK.L, Roche ROG.S, Sanofi SASY.PA and Novartis NOVN.S fell between 5% and 6.5% in Europe. Meanwhile, Indian pharmaceutical stocks .NIPHARM closed nearly 2% lower, dragging down the benchmark Nifty 50 .NSEI by 0.6%.
IPCA Laboratories IPCA.NS, Glenmark Pharma GLEN.NS and Biocon BION.NS were the top losers by percentage on the pharma index in Mumbai, ending the trading session between 4% and 5.5% lower.
India's pharma exports to the U.S. mostly comprise generics, or cheaper versions of popular drugs. The United States accounts for a third of India's overall pharma exports.
European pharma companies hit by looming tariff threat https://reut.rs/3Efihqg
BREAKINGVIEWS-Big Pharma has partial immunity from Trump tariffs nL5N3QM18T
(Reporting by Kashish Tandon, Ananta Agarwal and Manas Mishra in Bengaluru and Anna Pruchnicka in Gdansk; Editing by Savio D'Souza, Mrigank Dhaniwala and Shounak Dasgupta)
Trump's latest tariff threat ends brief reprieve for Indian pharma stocks
By Kashish Tandon
April 4 (Reuters) - Indian pharmaceutical stocks .NIPHARM fell 4.4% on Friday, wiping out gains from the previous session, after U.S. President Donald Trump threatened steep tariffs on the sector.
"Pharma (tariffs) is going to be starting to come in, I think, at a level that you haven't really seen before," Trump told reporters aboard Air Force One.
"That will be announced in the near future, and is under review right now," Trump said.
The index was among the top sectoral losers by percentage on the benchmark Nifty 50 .NSEI, which was down about 1.2% at 11:25 a.m. IST.
All 20 constituents of the pharma index were trading in the red, with Sun Pharma SUN.NS, Dr Reddy's REDY.NS and Cipla CIPL.NS being the biggest drags.
Lupin LUPN.NS, Aurobindo Pharma ARBN. and Ipca Laboratories IPCA.NS fell about 6.5% each, and were the top losers by percentage.
Trump imposed a 10% tariff on most U.S. imports earlier this week, as well as much higher levies on dozens of rivals and allies alike, but temporarily exempted some goods, including pharmaceuticals, benefiting major exporters including India, Japan and Ireland.
Pharma stocks were a rare bright spot on Thursday as global drugmakers gained on relief that their products remained temporarily shielded from the tariffs.
However, executives and analysts had warned it was premature to celebrate as levies were still likely to come.
"If these tariffs are introduced, the manufacturers will have no choice but to pass on the impact to consumers," said Vishal Manchanda, an analyst at Systematix Institutional Equities.
Indian drugmakers have been on a 'wait and watch' mode and also raised concerns on the difficulty in setting up manufacturing in the U.S., a move that would increase their costs.
Trump in his Wednesday address had predicted pharma companies would come "roaring back" to the U.S, and warned that "they got a big tax to pay" if they don't.
(Reporting by Kashish Tandon in Bengaluru; Editing by Varun H K)
(([email protected]; 8800437922;))
By Kashish Tandon
April 4 (Reuters) - Indian pharmaceutical stocks .NIPHARM fell 4.4% on Friday, wiping out gains from the previous session, after U.S. President Donald Trump threatened steep tariffs on the sector.
"Pharma (tariffs) is going to be starting to come in, I think, at a level that you haven't really seen before," Trump told reporters aboard Air Force One.
"That will be announced in the near future, and is under review right now," Trump said.
The index was among the top sectoral losers by percentage on the benchmark Nifty 50 .NSEI, which was down about 1.2% at 11:25 a.m. IST.
All 20 constituents of the pharma index were trading in the red, with Sun Pharma SUN.NS, Dr Reddy's REDY.NS and Cipla CIPL.NS being the biggest drags.
Lupin LUPN.NS, Aurobindo Pharma ARBN. and Ipca Laboratories IPCA.NS fell about 6.5% each, and were the top losers by percentage.
Trump imposed a 10% tariff on most U.S. imports earlier this week, as well as much higher levies on dozens of rivals and allies alike, but temporarily exempted some goods, including pharmaceuticals, benefiting major exporters including India, Japan and Ireland.
Pharma stocks were a rare bright spot on Thursday as global drugmakers gained on relief that their products remained temporarily shielded from the tariffs.
However, executives and analysts had warned it was premature to celebrate as levies were still likely to come.
"If these tariffs are introduced, the manufacturers will have no choice but to pass on the impact to consumers," said Vishal Manchanda, an analyst at Systematix Institutional Equities.
Indian drugmakers have been on a 'wait and watch' mode and also raised concerns on the difficulty in setting up manufacturing in the U.S., a move that would increase their costs.
Trump in his Wednesday address had predicted pharma companies would come "roaring back" to the U.S, and warned that "they got a big tax to pay" if they don't.
(Reporting by Kashish Tandon in Bengaluru; Editing by Varun H K)
(([email protected]; 8800437922;))
Lupin's UK Unit Acquires Renascience Pharma
April 2 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - UNIT LUPIN HEALTHCARE UK ACQUIRES RENASCIENCE PHARMA
LUPIN LTD - ACQUISITION COST GBP 12.3 MILLION
LUPIN LTD - ACQUISITION TO EXTEND LUPIN'S SPECIALTY PHARMA PORTFOLIO IN UK
Source text: ID:nNSE13ZqF0
Further company coverage: LUPN.NS
(([email protected];))
April 2 (Reuters) - Lupin Ltd LUPN.NS:
LUPIN LTD - UNIT LUPIN HEALTHCARE UK ACQUIRES RENASCIENCE PHARMA
LUPIN LTD - ACQUISITION COST GBP 12.3 MILLION
LUPIN LTD - ACQUISITION TO EXTEND LUPIN'S SPECIALTY PHARMA PORTFOLIO IN UK
Source text: ID:nNSE13ZqF0
Further company coverage: LUPN.NS
(([email protected];))
UPDATE 5-Eli Lilly launches weight-loss drug Mounjaro in India, beats Novo Nordisk to major market
Lilly beats Novo Nordisk to launch weight-loss drug in India
Mounjaro's 5 mg vial priced at around $50, 2.5 mg at about $40
Drug's pricing may limit accessibility in India, analyst says
Novo's Wegovy already approved in India
Updates March 20 story with Novo Nordisk comment on Wegovy launch timing in paragraph 11
By Rishika Sadam
HYDERABAD, March 21 (Reuters) - Eli Lilly launched its blockbuster diabetes and weight-loss drug Mounjaro in India on Thursday, beating rival Novo Nordisk for a much-awaited entry into the world's most populous country grappling with increasing rates of obesity and diabetes.
U.S.-based Lilly LLY.N and Danish Novo Nordisk NOVOb.CO have seen skyrocketing global demand for their innovative weight-loss drugs, with investor interest also boosting the drugmakers' valuations.
Mounjaro, a once-weekly injection approved by India's drug regulator, is priced at 4,375 rupees ($50.67) for a 5 mg vial and 3,500 rupees ($40.54) for a 2.5 mg vial, its lowest doses, the company told Reuters exclusively. Its highest dose is 15 mg.
A patient in India may have to spend about $200 a month when taking a weekly dose of 5 mg, subject to doctor's prescription.
Mounjaro carries a list price of $1,086.37 for each monthly fill in the U.S., but the amount patients pay largely depends on their insurance plan. Lilly also offers 5 mg, 7.5 mg and 10 mg vials of Zepbound, with prices around $499 for a month's supply if customers pay directly in cash without any third-party entities.
Chemically known as tirzepatide, Mounjaro is currently sold in the UK and Europe under the same brand name for both diabetes and weight loss. It is sold as Zepbound for obesity in the U.S.
Lilly, however, said that the pricing in different geographies cannot be compared given significant variation in healthcare systems, economies and reimbursement policies in each country.
"(Mounjaro) launch is ahead of Novo Nordisk and the first mover advantage should help ... but pricing seems high (for the Indian market). At the highest dose, a patient will have to spend close to 700,000 rupees (around $8,100) per annum," Vishal Manchanda, analyst at Systematix Institutional Equities said.
Novo's weight-loss drug, Wegovy, can cost non-insured U.S. patients more than $1,000 a month.
Novo's India team has been pushing the global leadership to launch Wegovy as early as 2025 in the country as opposed to the company's target of a 2026 launch.
The drugmaker told Reuters that Wegovy has already been approved in India, but said it did not have a confirmed date for the medicine's launch there.
The company's shares were down 0.6% at 1145 GMT, underperforming the broader European market .STOXX. Shares of U.S.-based Lilly rose as much as 2.07% to $854.39 on Thursday.
Novo's stock has fallen over 12% so far this year, while Lilly's has jumped 8%.
Novo is not the only competition Lilly will have to confront in India. Local drugmakers such as Sun Pharma SUN.NS, Cipla CIPL.NS, Dr. Reddy's REDY.NS and Lupin LUPN.NS have been racing to make generic versions of these drugs to grab a share of the global market estimated to be worth $150 billion in the next decade.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
"The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India," said President and General Manager Winselow Tucker at Lilly India.
Obesity and diabetes rates in India, a country of more than 1.4 billion people, have been steadily climbing. The number of adults with diabetes is set to increase to over 124 million by 2045 from 74.2 million in 2021, according to International Diabetes Federation.
Meanwhile, a government survey conducted between 2019 and 2021 showed that 24% of women and nearly 23% of men between the ages of 15 and 49 were either overweight or obese, up from 20.6% of women and 19% of men in 2015-2016.
Wegovy and Novo's diabetes drug, Ozempic — which has the same main ingredient — and Mounjaro, belong to a class of therapies known as GLP-1 receptor agonists that help control blood sugar and slow digestion, making people feel fuller for longer.
($1 = 86.3425 Indian rupees)
FACTBOX- Lilly's weight-loss drug launch in India to energize rivals eyeing mega market https://www.reuters.com/business/healthcare-pharmaceuticals/lillys-weight-loss-drug-launch-india-energize-rivals-eyeing-mega-market-2025-03-20/
Countries where Eli Lilly's Mounjaro is launched or approved https://reut.rs/4hFAf33
(Reporting by Rishika Sadam in Hyderabad, Maggie Fick in London and Bhanvi Satija in Bengaluru; Additional reporting by Manvi Pant in Bengaluru; Editing by Janane Venkatraman, Alan Barona and Tomasz Janowski)
Lilly beats Novo Nordisk to launch weight-loss drug in India
Mounjaro's 5 mg vial priced at around $50, 2.5 mg at about $40
Drug's pricing may limit accessibility in India, analyst says
Novo's Wegovy already approved in India
Updates March 20 story with Novo Nordisk comment on Wegovy launch timing in paragraph 11
By Rishika Sadam
HYDERABAD, March 21 (Reuters) - Eli Lilly launched its blockbuster diabetes and weight-loss drug Mounjaro in India on Thursday, beating rival Novo Nordisk for a much-awaited entry into the world's most populous country grappling with increasing rates of obesity and diabetes.
U.S.-based Lilly LLY.N and Danish Novo Nordisk NOVOb.CO have seen skyrocketing global demand for their innovative weight-loss drugs, with investor interest also boosting the drugmakers' valuations.
Mounjaro, a once-weekly injection approved by India's drug regulator, is priced at 4,375 rupees ($50.67) for a 5 mg vial and 3,500 rupees ($40.54) for a 2.5 mg vial, its lowest doses, the company told Reuters exclusively. Its highest dose is 15 mg.
A patient in India may have to spend about $200 a month when taking a weekly dose of 5 mg, subject to doctor's prescription.
Mounjaro carries a list price of $1,086.37 for each monthly fill in the U.S., but the amount patients pay largely depends on their insurance plan. Lilly also offers 5 mg, 7.5 mg and 10 mg vials of Zepbound, with prices around $499 for a month's supply if customers pay directly in cash without any third-party entities.
Chemically known as tirzepatide, Mounjaro is currently sold in the UK and Europe under the same brand name for both diabetes and weight loss. It is sold as Zepbound for obesity in the U.S.
Lilly, however, said that the pricing in different geographies cannot be compared given significant variation in healthcare systems, economies and reimbursement policies in each country.
"(Mounjaro) launch is ahead of Novo Nordisk and the first mover advantage should help ... but pricing seems high (for the Indian market). At the highest dose, a patient will have to spend close to 700,000 rupees (around $8,100) per annum," Vishal Manchanda, analyst at Systematix Institutional Equities said.
Novo's weight-loss drug, Wegovy, can cost non-insured U.S. patients more than $1,000 a month.
Novo's India team has been pushing the global leadership to launch Wegovy as early as 2025 in the country as opposed to the company's target of a 2026 launch.
The drugmaker told Reuters that Wegovy has already been approved in India, but said it did not have a confirmed date for the medicine's launch there.
The company's shares were down 0.6% at 1145 GMT, underperforming the broader European market .STOXX. Shares of U.S.-based Lilly rose as much as 2.07% to $854.39 on Thursday.
Novo's stock has fallen over 12% so far this year, while Lilly's has jumped 8%.
Novo is not the only competition Lilly will have to confront in India. Local drugmakers such as Sun Pharma SUN.NS, Cipla CIPL.NS, Dr. Reddy's REDY.NS and Lupin LUPN.NS have been racing to make generic versions of these drugs to grab a share of the global market estimated to be worth $150 billion in the next decade.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
"The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India," said President and General Manager Winselow Tucker at Lilly India.
Obesity and diabetes rates in India, a country of more than 1.4 billion people, have been steadily climbing. The number of adults with diabetes is set to increase to over 124 million by 2045 from 74.2 million in 2021, according to International Diabetes Federation.
Meanwhile, a government survey conducted between 2019 and 2021 showed that 24% of women and nearly 23% of men between the ages of 15 and 49 were either overweight or obese, up from 20.6% of women and 19% of men in 2015-2016.
Wegovy and Novo's diabetes drug, Ozempic — which has the same main ingredient — and Mounjaro, belong to a class of therapies known as GLP-1 receptor agonists that help control blood sugar and slow digestion, making people feel fuller for longer.
($1 = 86.3425 Indian rupees)
FACTBOX- Lilly's weight-loss drug launch in India to energize rivals eyeing mega market https://www.reuters.com/business/healthcare-pharmaceuticals/lillys-weight-loss-drug-launch-india-energize-rivals-eyeing-mega-market-2025-03-20/
Countries where Eli Lilly's Mounjaro is launched or approved https://reut.rs/4hFAf33
(Reporting by Rishika Sadam in Hyderabad, Maggie Fick in London and Bhanvi Satija in Bengaluru; Additional reporting by Manvi Pant in Bengaluru; Editing by Janane Venkatraman, Alan Barona and Tomasz Janowski)
FACTBOX-Lilly's weight-loss drug launch in India to energize rivals eyeing mega market
March 20 (Reuters) - Eli Lilly LLY.N on Thursday launched in India its diabetes and weight-loss drug, Mounjaro, which has already clocked in over $20 billion in global sales since its initial U.S. launch in 2022.
India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.
Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:
NOVO NORDISK
The Danish drugmaker NOVOb.CO had said it aims to launch its blockbuster weight-loss drug, Wegovy, in India by 2026.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply. GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.
SUN PHARMA
Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.
The drugmaker said earlier this month it expects to launch the drug in the next four to five years.
BIOCON
Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.
ZYDUS LIFESCIENCES
India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.
CIPLA
Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.
Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.
DR. REDDY'S
India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.
LUPIN
India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.
NATCO, MANKIND PHARMA, AUROBINDO PHARMA
Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.
Reuters was not able to independently verify the reports.
(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)
(([email protected];))
March 20 (Reuters) - Eli Lilly LLY.N on Thursday launched in India its diabetes and weight-loss drug, Mounjaro, which has already clocked in over $20 billion in global sales since its initial U.S. launch in 2022.
India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.
Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:
NOVO NORDISK
The Danish drugmaker NOVOb.CO had said it aims to launch its blockbuster weight-loss drug, Wegovy, in India by 2026.
The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.
Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply. GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.
SUN PHARMA
Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.
The drugmaker said earlier this month it expects to launch the drug in the next four to five years.
BIOCON
Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.
ZYDUS LIFESCIENCES
India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.
CIPLA
Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.
Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.
DR. REDDY'S
India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.
LUPIN
India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.
NATCO, MANKIND PHARMA, AUROBINDO PHARMA
Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.
Reuters was not able to independently verify the reports.
(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)
(([email protected];))
Lupin Says Subsidiary Lupinlife Consumer Healthcare Incorporated
March 18 (Reuters) - Lupin Ltd LUPN.NS:
SUBSIDIARY LUPINLIFE CONSUMER HEALTHCARE INCORPORATED
Source text: ID:nBSE1s9BDw
Further company coverage: LUPN.NS
(([email protected];;))
March 18 (Reuters) - Lupin Ltd LUPN.NS:
SUBSIDIARY LUPINLIFE CONSUMER HEALTHCARE INCORPORATED
Source text: ID:nBSE1s9BDw
Further company coverage: LUPN.NS
(([email protected];;))
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What does Lupin do?
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in many markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Who are the competitors of Lupin?
Lupin major competitors are Mankind Pharma, Zydus Lifesciences, Dr. Reddy's Lab, Alkem Laboratories, Aurobindo Pharma, Abbott India, Torrent Pharma. Market Cap of Lupin is ₹89,382 Crs. While the median market cap of its peers are ₹1,00,805 Crs.
Is Lupin financially stable compared to its competitors?
Lupin seems to be less financially stable compared to its competitors. Altman Z score of Lupin is 7.09 and is ranked 5 out of its 8 competitors.
Does Lupin pay decent dividends?
The company seems to be paying a very low dividend. Investors need to see where the company is allocating its profits. Lupin latest dividend payout ratio is 16.7% and 3yr average dividend payout ratio is 26.02%
How has Lupin allocated its funds?
Companies resources are allocated to majorly unproductive assets like Cash & Short Term Investments
How strong is Lupin balance sheet?
Balance sheet of Lupin is strong. It shouldn't have solvency or liquidity issues.
Is the profitablity of Lupin improving?
Yes, profit is increasing. The profit of Lupin is ₹3,722 Crs for TTM, ₹3,282 Crs for Mar 2025 and ₹1,914 Crs for Mar 2024.
Is the debt of Lupin increasing or decreasing?
The net debt of Lupin is decreasing. Latest net debt of Lupin is -₹1,185.51 Crs as of Mar-25. This is less than Mar-24 when it was ₹286 Crs.
Is Lupin stock expensive?
Lupin is not expensive. Latest PE of Lupin is 24.16, while 3 year average PE is 57.36. Also latest EV/EBITDA of Lupin is 15.9 while 3yr average is 32.99.
Has the share price of Lupin grown faster than its competition?
Lupin has given better returns compared to its competitors. Lupin has grown at ~30.96% over the last 2yrs while peers have grown at a median rate of 18.08%
Is the promoter bullish about Lupin?
Promoters stake in the company seems stable, and we need to go through filings and allocation of resources to gauge promoter bullishness. Latest quarter promoter holding in Lupin is 46.9% and last quarter promoter holding is 46.9%.
Are mutual funds buying/selling Lupin?
The mutual fund holding of Lupin is increasing. The current mutual fund holding in Lupin is 20.57% while previous quarter holding is 19.35%.