LUPIN

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)

(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)

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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)

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March 18 (Reuters) - Lupin Ltd LUPN.NS:

• SUBSIDIARY LUPINLIFE CONSUMER HEALTHCARE INCORPORATED

Source text: ID:nBSE1s9BDw

Further company coverage: LUPN.NS

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March 7 (Reuters) - Lupin Ltd LUPN.NS:

• LAUNCHES RIVAROXABAN TABLETS USP, 2.5MG IN UNITED STATES

Source text: ID:nBSE8cbHCM

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By Mike Scarcella

Feb 18 (Reuters) - Swiss generic drug manufacturer Sandoz has agreed to pay $275 million to resolve claims by U.S. consumers and others who accused the company of conspiring with industry rivals to illegally fix prices.

Attorneys for the plaintiffs, including the City of Providence, Rhode Island and a New York City police employee benefits plan, asked U.S. District Judge Cynthia Rufe in Philadelphia on Friday to approve the settlement.

Sandoz denied any wrongdoing in agreeing to settle. The company said it will cooperate with the plaintiffs as they pursue claims against other drugmakers.

The antitrust case includes several drug makers that were not part of Friday's settlement, including Pfizer, Teva and Lupin. The companies did not immediately respond to requests for comment and have denied wrongdoing.

Sandoz and attorneys for the plaintiffs, "end-purchasers" including consumers who bought Sandoz drugs from pharmacies, did not immediately respond to requests for comment.

The settlement period covers some purchases between 2009 and 2019 for drugs, including the antidepressants amitriptyline and clomipramine, and for clobetasol, which is used to treat some skin conditions.

The settlement class likely includes millions of members with claims tied to Sandoz’s alleged price-fixing, the plaintiffs' lawyers told the court.

Their court filing said “continued litigation of the claims against Sandoz would be protracted and without guarantee of any recovery.”

The attorneys said they will seek up to $91.6 million in legal fees and $26 million in litigation expenses.

Sandoz last year agreed to pay $265 million to resolve related claims lodged in the litigation by a group of wholesale drug purchasers and others.

The case is In re Generic Pharmaceuticals Pricing Antitrust Litigation, U.S. District Court for the Eastern District of Pennsylvania, No. 2:16-MD-02724.

For end-payor class: Roberta Liebenberg and Jeffrey Istvan of Fine, Kaplan and Black

For Sandoz: Matthew Kent of Alston & Bird

Read more:

Drugmakers Apotex, Heritage to pay $49 mln to resolve states' price-fixing claims

Ex-Sandoz exec gets probation for price-fixing after cooperation deal

US drops price-fixing case against former Taro Pharmaceutical executive

** Drug manufacturer Lupin LUPN.NS up 3.79% to 2102 rupees

** Co's Q3 core profit margin expands 402 basis points y/y

** Analysts expect co to sustain high U.S. sales growth led by high value launches such as key diuretic Tolvaptan

** Co has 6-months exclusivity for Tolvaptan during which it aims to get 30-40% volume share

** "We see semaglutide (used for GLP-1 weight loss drug) as a key growth driver"- HSBC

** Nomura expects growth recovery in India due to Lupin's strong presence in chronic therapies

** Adds, "We expect Lupin to address GLP-1 opportunities in India and emerging markets from FY27"

** Including session's gains, LUPN up 30.4% in last 12 months

** LUPN rated 'hold' on avg by 32 analysts- LSEG compiled data

(Reporting by Ananta Agarwal in Bengaluru)

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Feb 10 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LTD - CO AND NATCO RECEIVE U.S. FDA APPROVAL FOR BOSENTAN TABLETS

Source text: ID:nBSEb28kSJ

Further company coverage: LUPN.NS

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Feb 3 (Reuters) - Lupin Ltd LUPN.NS:

• GETS TENTATIVE APPROVAL FROM U.S. FDA FOR DARUNAVIR, COBICISTAT TABLETS

• GETS TENTATIVE APPROVAL FROM U.S. FDA FOR EMTRICITABINE, TENOFOVIR ALAFENAMIDE TABLETS

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Jan 9 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR IVACAFTOR ORAL GRANULES

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** Shares of India's Lupin LUPN.NS rise 2.6% to a record high of 2370.6 rupees, in an otherwise weak broader market

** LUPN among top pct gainers in the Nifty pharma index .NIPHARM, which is up 0.9%

** Drugmaker buys diabetes drug Huminsulin in India from Eli Lilly LLY.N; no financials disclosed

** Over 2 mln LUPN shares traded, over twice its 30-day avg

** Analysts' avg rating on stock is "hold," same as for Dr Reddy's REDY.NS and Cipla CIPL.NS - LSEG

** Their median PT on LUPN is 2259 rupees - LSEG

** YTD stock has jumped 78% vs 39% gain in Nifty pharma

(Reporting by Aleef Jahan in Bengaluru)

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Dec 18 (Reuters) - Lupin Ltd LUPN.NS:

• GOT APPROVAL FROM U.S. FDA FOR ITS ANDA FOR EMTRICITABINE, TENOFOVIR ALAFENAMIDE TABLETS

Source text: ID:nBSE75XgNP

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Dec 13 (Reuters) - Lupin Ltd LUPN.NS:

• ACQUIRES ANTI-DIABETES TRADEMARKS FROM BOEHRINGER INGELHEIM

• TRADEMARK RIGHTS TO BE TRANSFERRED TO LUPIN BY MARCH

Source text: ID:nBSE9zxDqZ

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Dec 9 (Reuters) - Life Insurance Corporation of India LIFI.NS:

• LIFE INSURANCE CORP OF INDIA CUTS STAKE IN LUPIN BY 2.027% TO 2.542% - EXCHANGE FILING

Source text: ID:nBSE1Ftvv4

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Dec 2 (Reuters) - Lupin Ltd LUPN.NS:

• GOT TENTATIVE APPROVAL FROM U.S. FDA FOR SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS

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Nov 7 (Reuters) - Lupin Ltd LUPN.NS:

• Q2 CONSOL NET PAT 8.53 BILLION RUPEES; IBES PROFIT EST. 7.29 BILLION RUPEES

• Q2 CONSOL TOTAL REVENUE FROM OPERATIONS 56.73 BILLION RUPEES; IBES EST. 55.35 BILLION RUPEES

Source text: ID:nnAPN2DJ2DJ

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Oct 15 (Reuters) - Lupin Ltd LUPN.NS:

• LAUNCHES FIRST GENERIC OF PRED FORTE® IN UNITED STATES

• LUPIN LAUNCHES FIRST GENERIC OF PRED FORTE IN UNITED STATES

Source text for Eikon: ID:nBSE3mg5BW

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Sept 18 (Reuters) - Lupin Ltd LUPN.NS:

• ENTERED INTO NON-EXCLUSIVE PATENT LICENSE AGREEMENT WITH TAKEDA PHARMACEUTICAL

• AGREEMENT TO COMMERCIALIZE VONOPRAZAN TABLETS IN INDIAN MARKET

• TAKEDA HAS GRANTED CO NON-EXCLUSIVE PATENT RIGHTS TO COMMERCIALIZE VONOPRAZAN IN INDIA

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** Shares of India's Lupin LUPN.NS gain ~2% to 2,248 rupees

** Drugmaker bought 42.61% stake in Sunsure Solarpark for 105.5 mln rupees ($1.26 mln) to purchase renewable power

** LUPN among top pct gainers in Nifty pharma index .NIPHARM, which is up 0.4%

** YTD stock has jumped 70% vs 39% gain in NIPHARM

($1 = 83.9825 Indian rupees)

(Reporting by Hritam Mukherjee in Bengaluru)

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Sept 4 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - LAUNCHES MIRABEGRON EXTENDED-RELEASE TABLETS IN UNITED STATES

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** Drugmaker Lupin LUPN.NS gains 2.3% to 2,243.8 rupees

** Nomura maintains "buy", raises TP from 2,201 rupees to 2,427 rupees - the second highest among analysts tracking stock

** Says LUPN's strong earnings, recovery in key markets and sustained cost control justifies premium valuations

** Adds co's new product approvals and launches have increased after US drug regulator's approvals in FY24

** Avg rating of analysts is "hold"; median TP is 1,910 rupees, 15% below current price - LSEG data

** LUPN has gained 69% in 2024 so far, outperforming the 37.5% rise in pharma index .NIPHARM and 16% rise in benchmark Nifty 50 index .NSEI

(Reporting by Bharath Rajeswaran in Bengaluru)

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** Shares of Lupin LUPN.NS gain ~3% to 2,047.85 rupees, their highest in nearly nine years

** Stock climbs 7% since reporting Q1 results above expectations on Tuesday

** CLSA expects sustained U.S. sales over FY25-26 led by increased market share and likely delay in competition for pulmonary drug gSpiriva, upgrades rating to "hold"

** Timely approval and launch of complex generics, including generic Glucagon for treating Type 2 diabetes, key to sustained sales growth in U.S., says HSBC as it maintains "hold" rating and raises PT to 1,920 rupees

** Analysts' average rating on LUPN at "hold", vs "buy" for rivals Cipla CIPL.NS and Sun Pharma SUN.NS - LSEG data

** LUPN's 12-month fwd P/E of 34x higher than CIPL's 26x but below SUN's 35x - LSEG data

** LUPN gains ~55% YTD vs 32% climb in pharma index .NIPHARM

(Reporting by Kashish Tandon in Bengaluru)

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** Shares of Indian drug-maker Lupin LUPN.NS open 6% higher at 2,029.95 rupees, highest level since Oct 2015

** Co on Tuesday reported a 77% surge in Q1 profit, beating estimates, while rev rose 16.3%

** Upcycle across businesses will drive expansion in earnings before interest, taxes, depreciation, and amortization and earnings growth - Nomura

** Lupin shares up 49% YTD, fifth biggest gainer among 20 stocks in pharma index .NIPHARM, which is up 30%

** Lupin "hold" rated on average; median PT at 1,615 rupees - LSEG

(Reporting by Sethuraman NR in Bengaluru)

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July 12 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN RECEIVES EIR FROM U.S. FDA FOR ITS DABHASA FACILITY

• INSPECTION CONCLUDED WITH NO OBSERVATIONS

• FACILITY RECEIVING INSPECTION CLASSIFICATION OF NO ACTION INDICATED

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July 9 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN: FY25 GROWTH IN BRAZIL TO BE DRIVEN BY PRICE HIKES, PERFORMANCE OF KEY PRODUCTS - ANNUAL REPORT

• LUPIN: IN AUSTRALIA, ANTICIPATES MARKET EROSION IN TOP PRODUCTS DUE TO NEW ENTRANTS - ANNUAL REPORT

  
  

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** Shares of Lupin LUPN.NS rise 4.9% to 1,709 rupees

** Stock top gainer on Nifty pharma index .NIPHARM, which is up 0.77%

** Kotak double upgrades stock to "add" from "sell"; raises PT to 1,805 rupees from 1,400 rupees

** Strong trajectory to continue till FY26 amid a stable pricing of generic drugs in US, analysts at Kotak Institutional Equities say

** Add, expect 12% and 11% Y/Y growth from US sales in FY25 and FY26, respectively

** More than 3 mln shares change hands, 2.1x its 30-day avg

** Thirty analysts covering the stock on avg have a "hold" rating; median PT is 1,600 rupees - LSEG data

** Stock up 29% so far this year vs a 12.2% rise in Nifty 50 index .NSEI

(Reporting by Ashna Teresa Britto in Bengaluru)

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June 28 (Reuters) - Lupin Ltd LUPN.NS:

• RECEIVED AN ORDER FROM COURT OF JUSTICE OF EUROPEAN UNION

• CO WILL BE REQUIRED TO MAKE PAYMENT OF EURO 40 MLN, INTEREST THEREON TO EUROPEAN COMMISSION

• EUROPEAN COURT DISMISSED FINAL APPEAL BY CO AGAINST ORDER OF EUROPEAN COMMISSION LEVYING FINE OF EURO 40 MILLION, IN 2014

Source text for Eikon: ID:nNSESBmZp

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June 17 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LTD - APPOINTMENT OF ABDELAZIZ TOUMI AS CEO OF LUPIN MANUFACTURING SOLUTIONS

Source text for Eikon: ID:nBSE1fFX1G

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June 14 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LTD - LUPIN ANNOUNCES CLOSURE OF US FDA INSPECTION AT ITS INJECTABLE FACILITY WITH ZERO 483 OBSERVATIONS

Source text for Eikon: [ID:]

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June 5 (Reuters) - Lupin Ltd LUPN.NS:

• COMPLETES ACQUISITION OF TWO BRANDS FROM SANOFI IN EUROPE AND CANADA

• ACQUISITION TO ENHANCE LUPIN'S RESPIRATORY BUSINESS IN GERMANY

• LUPIN ATLANTIS HOLDINGS SA COMPLETED ACQUISITION OF AARANETM IN GERMANY, NALCROMTM IN CANADA, NETHERLANDS

Source text for Eikon: ID:nBSE7x89N5

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By Rishika Sadam

HYDERABAD, May 30 (Reuters) - India's pharmaceutical export sales growth is expected to pick up to nearly 11% this fiscal year, from a roughly 10% increase last year, led by the key U.S. and UK markets, a government-backed trade body said on Thursday.

India, the world's third-largest drugmaker by volume, has seen exports soaring despite global countries' concerns regarding the quality of medicinal products following cough syrup-linked deaths in Gambia and Uzbekistan.

Exports are expected to cross $31 billion in the year ending March 31, compared with exports of nearly $28 billion in fiscal 2024, according to Pharmaceuticals Export Promotion Council of India (Pharmexcil).

The growth markets will be the United States, UK, Latin America and Africa, Udaya Bhaskar, the director general of Pharmexcil, told Reuters on the sidelines of an event in Hyderabad.

Among them the U.S. is a key market -- it accounts for about 30% of India's annual pharma exports after a nearly 16% increase in fiscal 2024, according to Pharmexcil.

The country's drug shortages as well as the increased use of drugs for lifestyle diseases such as diabetes, hypertension and depression will aid demand for India's affordably priced drugs, Bhaskar said.

Earlier this week, India Ratings and Research shared a similar view, saying the U.S. market will help Indian drugmakers sustain their revenue improvement this fiscal year.

However, Bhaskar sees potential in the UK market as well.

"The UK is a sweet spot. I was talking to doctors at NHS (National Health Service) and there is also a shortage. Post-COVID, drugs from Europe have become expensive ... (and) things have changed post BREXIT."

"So, this is one market where India can evolve."

India, he believes, needs to move beyond making generic drugs get ahead in the global pharma industry, but also noted the challenges.

"Unfortunately, the industry is not spending more. The government support is also not adequate."

(Reporting by Rishika Sadam, writing by Kashish Tandon; Editing by Savio D'Souza)

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