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With the patent for Danish drug major Novo Nordisk's blockbuster anti-obesity and anti-diabetes drug semaglutide meets expiry by March, 2026, three Indian manufacturers have received nod from the Subject Expert Committee (SEC) of the central drug regulator to manufacture and market their formulations for treatment of type 2 diabetes subject to conditions.
Out of the three companies, Torrent Pharmaceuticals received favourable recommendation for various strengths of its oral formulation, while MSN Laboratories and Natco Pharma received recommendation for grant of permission to manufacture and market injection vials and multidose pens of various strengths, respectively.
The decision was made by the SEC on endocrinology and metabolism, on January 6, 2026, considering the application of these companies under the Subsequent New Drugs (SND) division of the Central Drugs Standard Control Organisation (CDSCO). While it was also scheduled to consider the application of Cipla Ltd for the injection form of the drug, the company did not turn up for presentation.
MSN Laboratories applied for semaglutide Injection 2 mg/3 ml (0.68 mg/ml), 4 mg/3 ml (1.34 mg/ml) & 8 mg/3 ml (2.68 mg/ml) (Synthetic Origin), and presented phase III clinical trial report for type 2 diabetes before the Committee. The Committee accepted the report and recommended for grant of permission for manufacture and market the formulations for certain indications with condition for submission of post marketing surveillance and periodic safety update reports, as per the NDCT Rules, 2019.
Natco's application for semaglutide solution for Injection, multidose prefilled pens 2 mg/1.5 ml (1.34 mg/ml), 4 mg/3 ml (1.34 mg/ml) & 8 mg/3 ml (2.68 mg/ml) (synthetic origin), was also considered with phase III study report and similar decision was made during the meeting.
Torrent's application for semaglutide tablets 3mg, 7 mg & 14 mg (synthetic origin) was considered along with phase III study report and approved for the same indications.
The approval for all the three formulations are indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, as monotherapy, when metformin is considered inappropriate due to intolerance or contradictions and as an addition to other medicinal products for the treatment of diabetes.
Semaglutide, the patented blockbuster from Novordisk, is sold under the brand name Rybelsus as oral formulation, Ozempic as an injectable for diabetes, and Wegovy, as an injectable for treatment of obesity. According to health information technology firm IQVIA, it is the world’s second-best selling prescription medicine, with combined sales of $26 billion in 2024 and growing annually at a staggering 40%.
With the patent scheduled to expire in March, this year, Novo Nordisk has locked horns with various Indian generic manufacturers to block the launch of generic equivalents. Indian manufacturers Sun Pharma, Dr Reddy's Laboratories, and Alkem already have the necessary regulatory approvals at present for the generic version of the drug, according to reports.
Over 10 companies have filed SEC submissions in India to conduct Phase III studies for semaglutide, with 7 of them focusing on oral semaglutide, seemingly looking to differentiate away from the most common presentation.
Systematix Institutional Equities, in a report on January 2, 2026, said that the patent expiry of semaglutide in India, emerging markets and regulated markets (Brazil, Canada) could create an incremental revenue opportunity of over Rs. 5,000 crore for generic versions over the next 12-15 months.
"This opportunity is likely to be shared among 10- 15 players, comprising Indian and global generic manufacturers. For FY27E, we see this as a Rs. 10-Rs. 20 billion incremental revenue opportunity in India branded formulation space, ~Rs. 45 billion in regulated markets (Canada and Brazil) and Rs. 5 billion-Rs. 10 billion for emerging markets (EM)," said the report.
The India launch can add about 0.5 to 1 per cent to the Indian Pharmaceutical Market (IPM) growth in FY27, and it expects the adoption of GLP-1 therapy among diabetics to rise sharply, following the launch of generic semaglutide version in 1QFY27, and driven by an affordable price point - potentially 30% to 50% lower versus the current level, said the report.
Over time, prices could further correct as low as 70%-75% from current levels, while the market share within the GLP-1 segment may remain concentrated among the top Top 5-10 players, including Novo Nordisk, Emcure, Sun Pharma, Eris Lifesciences, Cipla, Lupin, Torrent Pharmaceuticals, Dr Reddy's, Alkem and Zydus Lifesciences, added the market research firm.
A report by the new agency Reuters said that Novo Nordisk launched Ozempic in India in December, 2025, with plans to sell the multidose pen format with strengths of 0.25 mg, 0.5 mg and 1 mg doses. A news agency report states that the monthly price of the drug would be Rs. 8,800 for 0.25 mg, Rs. 10,170 for 0.5 mg and Rs. 11,175 for 1 mg.
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