Lupin

July 1 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - ANNOUNCES EMA APPROVAL FOR NAMUSCLA PEDIATRIC INDICATION

Source text: ID:nNSE9pHGq9

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June 26 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR ENZALUTAMIDE TABLETS

Source text: ID:nCNWK3Klta

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

• LUPIN- LAUNCHES AZILSARTAN MEDOXOMIL TABLETS IN THE UNITED STATES

Source text: ID:nnAZN4T2SZZ

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June 8 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - COLLABORATES WITH LABORATORIOS ERN TO LAUNCH LUFORBEC (BECLOMETASONE/FORMOTEROL) PMDI IN SPAIN

Source text: ID:nNSE5RfCtd

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

• LUPIN RECEIVES APPROVAL FROM U.S. FDA FOR RANLUSPEC™(RANIBIZUMAB) INJECTION

Source text: ID:nPn57Fg26a

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

• LUPIN’S ANKLESHWAR FACILITY RECEIVES EIR FROM U.S. FDA

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May 22 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES CHINA APPROVAL FOR OSELTAMIVIR PHOSPHATE ORAL SUSPENSION

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

• LUPIN - LUPIN RECEIVES U.S. FDA APPROVAL FOR FAMOTIDINE INJECTION, USP

Source text: ID:nnAZN4SW0AC

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** India's Lupin LUPN.NS posted a profit of 14.6 billion rupees ($154.5 million) in Q4, up 89% Y/Y

** Shares of LUPN down ~4% to 2,364.3 rupees, after gaining about 5% in the previous two sessions ahead of earnings

STRONG U.S. MOMENTUM, INDIA RECOVERY

** Macquarie ("outperform", TP:2,460 rupees) sees strong visibility on co's upcoming U.S. launches and the resilience of its well-established domestic business

** Morgan Stanley ("equal-weight", TP:2,386 rupees) says Q4 results were driven by strong growth in its U.S. business due to new product launches and steady base business expansion; says India business resilient, supported by healthy growth in key therapies

** Nomura ("buy", PT:2,580 rupees) says margin expansion was supported favorable currency movements and a recovery in India growth, although overhead costs rose partly due to expenses related to the VISUfarma acquisition

($1 = 94.4725 Indian rupees)

(Reporting by Devika Nair in Bengaluru)

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

• MARCH-QUARTER CONSOL NET PROFIT 14.6 BILLION RUPEES

• MARCH-QUARTER CONSOL TOTAL REVENUE FROM OPERATIONS 74.75 BILLION RUPEES

• DIVIDEND 18 RUPEES PER SHARE

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

• LUPIN - RECEIVES U.S. FDA APPROVAL FOR GLYCEROL PHENYLBUTYRATE ORAL LIQUID

Source text: ID:nBSE3DnMTs

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April 22 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LAUNCHES DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS IN THE UNITED STATES

Source text: ID:nPn8H4D2Na

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

• INCORPORATES WHOLLY OWNED SUBSIDIARY LUPIN (THAILAND) LIMITED IN THAILAND ON APRIL 17, 2026

Source text: ID:nBSE2RP5Bv

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

• LUPIN - LAUNCHES DAPAGLIFLOZIN TABLETS IN THE UNITED STATES

Source text: ID:nnAZN4SQ8JK

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April 8 (Reuters) - Lupin Ltd LUPN.NS:

• ANNOUNCES APPROVAL OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLETS IN UNITED STATES

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Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR SUGAMMADEX INJECTION

Source text: [ID:]

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** Shares of Indian drugmaker Lupin LUPN.NS rise nearly 1% to 2366 rupees

** Co on Wednesday received tentative approval From U.S. FDA for Pitolisant tablets, to treat excessive daytime sleepiness in kids aged six and older people with narcolepsy

** Approval for Lupin's Pitolisant Tablets 4.45mg and 17.8 mg as bioequivalent to Wakix, co says

** More than 208,915 shares change hand by 11.11 am IST vs 30-day avg of 928,638 shares

** LUPN rated "buy" on avg by 35 analysts covering it; median PT at 2436 rupees

** YTD, LUPN up 11%

(Reporting by Komal Salecha in Bengaluru)

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Lupin Ltd LUPN.NS:

• LUPIN RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR PITOLISANT TABLETS

• LUPIN - RECEIVES TENTATIVE FDA APPROVAL FOR PITOLISANT TABLETS 4.45MG AND 17.8MG

Source text: ID:nPn8nqFXza

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By Rishika Sadam

HYDERABAD, March 19 (Reuters) - India's market for diabetes and weight-loss drugs is set for a shake-up as Danish drugmaker Novo Nordisk's NOVOb.CO patent on semaglutide expires this week, triggering a wave of cheaper generics from local drugmakers and worries about uneven oversight in an overcrowded market.

More than 40 Indian firms are expected to launch over 50 brands within weeks, analysts and doctors said, widening access in a price-sensitive market, but also raising concerns about misuse and confusion among prescribers as costs fall sharply.

Sun Pharma SUN.NS, Mankind Pharma MNKI.NS, Dr. Reddy's REDY.NS, Zydus ZYDU.NS, Lupin LUPN.NS and Alkem ALKE.NS are among the companies expected to launch generic versions of semaglutide, the active ingredient in Novo's diabetes drug Ozempic and weight-loss treatment Wegovy.

"With high demand, falling prices and multiple brands, you may see direct pharmacy purchases, distributor-level leakages, or cosmetic or lifestyle use especially in urban markets," said Salil Kallianpur, an independent analyst.

"This could lead to misuse, poor titration and unmanaged side effects and eventually regulatory tightening."

India's drug regulator did not respond to a request for comment. Semaglutide is a prescription drug, but enforcement in India has often been uneven, with doctors and pharmacists playing a key gatekeeping role.

The entry of generics will also challenge Novo and U.S. rival Eli Lilly LLY.N, which launched blockbuster diabetes and obesity drugs in India last year, as they seek to cement their position in the country.

Lilly's Mounjaro became India's top-selling drug by value within months of launch, according to data from Pharmarack, a research firm.

India, the world's most populous nation, has the second-highest number of adults with diabetes after China and could have more than 440 million overweight or obese people by 2050, according to The Lancet, a medical journal, and the International Diabetes Federation.

India's obesity drug market could grow to 80 billion rupees ($856.6 million) by 2030 from about 15 billion rupees today, according to Pharmarack estimates.

EYES ON THE PRICE

Indian generic drugmakers, known globally for producing low-cost medicines, are expected to price their generics at discounts of at least 50% to 60%.

Analysts say monthly prices for the lowest dose could fall from about 11,000 rupees to 3,000 to 5,000 rupees as early generics arrive and eventually to around 1,500 to 2,500 rupees, expanding access beyond a niche urban elite.

"I will consult my doctor to check if I can move to using a generic version, as that appears to be lighter on the pocket," said 32-year-old Vishal, a tech worker from Hyderabad, who is considering a switch from Wegovy.

Many other patients in India's out-of-pocket market have also begun enquiring about cheaper options, some of which are expected to launch as soon as Saturday, the day after Novo's patent expires.

"The price range being quoted is broadly 2,500 to 3,500 rupees, which is quite low," said bariatric surgeon Venugopal Pareek. Six of his patients are waiting for generic versions to switch from Novo or Lilly drugs.

Lower prices are expected to expand the patient pool.

"Onboarding of patients from lower economic strata may happen on branded generics," said Sheetal Sapale, commercial vice president at Pharmarack, noting that company profits would depend on pricing discipline.

Novo and Lilly did not immediately respond to Reuters requests for a comment.

DOCTORS' CHOICE

Even as prices fall, analysts say the winner in the market will depend not just on cost, but also on doctor confidence.

India's pharmaceutical market is heavily driven by physician prescriptions and uptake will depend on doctors' familiarity and confidence in individual brands.

An initial glut of products is likely to overwhelm prescribers, analysts said, with uneven experiences and aggressive marketing.

Many generic drugmakers are opting for brand names that incorporate "sema," which could also add to confusion.

Over time, analysts expect doctors' trust to consolidate around a handful of players offering reliable supply, quality delivery devices and consistent outcomes.

"Weaker players with poor quality and no differentiation will likely exit within two to three years," Kallianpur said.

(Reporting by Rishika Sadam; Editing by Dhanya Skariachan and Thomas Derpinghaus)

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

• CO AND LUPIN SIGN LICENSING AGREEMENT FOR CO-MARKETING INNOVATIVE SEMAGLUTIDE INJECTION IN INDIA

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

• LUPIN - TAX DEPARTMENT CONCLUDES INSPECTION AT LUPIN'S REGISTERED OFFICE

• LUPIN - NO IMPACT ON LUPIN'S FINANCIALS FROM GST PROCEEDINGS

• LUPIN - NO ADVERSE FINDINGS ISSUED BY TAX DEPARTMENT TO CO

Source text: ID:nNSE6drzdm

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Feb 27 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - VISUFARMA B.V. DEAL ANTICIPATED TO COMPLETE IN APRIL 2026

Source text: ID:nNSE3ylQqz

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Feb 25 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - TAX DEPARTMENT INITIATED INSPECTION AND SEARCH AT CO

• LUPIN - INSPECTION, SEARCH DOESN’T HAVE ANY IMPACT ON CO'S FINANCIALS, OPERATIONS

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Feb 24 (Reuters) - Lupin Ltd LUPN.NS:

• RECEIVES FDA APPROVAL FOR BRIVARACETAM ORAL SOLUTION

Source text: ID:nBSE2nrh2j

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Feb 23 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES EUROPEAN COMMISSION APPROVAL FOR BIOSIMILAR RANIBIZUMAB

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** Shares of India's Lupin LUPN.NS rise 1.35% to 2249.80 rupees

** Drugmaker signs license and supply agreement with Spektus Pharma to commercialize antidepressant Deslaflex in Canada

** Co says deal expands Lupin's central nervous system (CNS) portfolio in the Canadian market

** Trading vols at 424,238 shares vs 30-day-avg of 873,939 shares

** Stock rated "buy" on avg by 35 analysts, median PT at 2421.50 rupees

** LUPN dropped 10.45% in 2025, stock gained 5.3% so far in 2026

(Reporting by Surbhi Misra in Bengaluru)

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Repeats story from 13th Feburary with no changes to text

By Rishika Sadam

Feb 16 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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By Rishika Sadam

Feb 13 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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Adds stock prices in paragraph 4

Feb 12 (Reuters) - India's Zydus Lifesciences ZYDU.NS and its U.S. unit will pay $120 million to Astellas Pharma 4503.T as part of a deal to settle a patent dispute over the Japanese drugmaker's bladder disorder drug Mirabegron, the Indian firm said on Thursday.

Zydus and its unit will also pay a pre-paid per‑unit licensing fee on sales of its generic Mirabegron in the U.S. from the date of the agreement until September 2027, the company said.

The deal will enable the company to continue marketing its generic Mirabegron in the United States, Zydus said, adding that other terms and conditions of the agreement are confidential.

Shares of Zydus climbed as much as 1.3% shortly after the announcement.

The announcement comes days after local peer Lupin LUPN.NS decided to settle its dispute with Astellas over the same drug for $90 million.

At that time, analysts at brokerage Citi said the development could delay the entry of other generic rivals in the U.S. market, potentially providing Zydus and Lupin with a period of limited competition.

(Reporting by Hritam Mukherjee in Bengaluru; Editing by Sherry Jacob-Phillips)

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** Citi Research says Lupin's LUPN.NS $90 million patent settlement with Astellas Pharma 4503.T may prevent other generic drugmakers from launching generic Mirabegron for an extended period, potentially giving Lupin and Zydus Lifesciences ZYDU.NS about 12–18 months of limited competition

** Settlement allows Lupin to continue selling its generic version of Mirabegron, a bladder disorder drug, eliminating legal risks associated with prolonged litigation - Citi

** Citi maintains "buy" on LUPN at PT 2260 rupees

** Stock rated "buy" on avg by 35 analysts; median PT 2350 rupees - data compiled by LSEG

** Stock up 5% YTD; last up 1% at 2218 rupees

(Reporting by Aleef Jahan in Bengaluru)

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