With the patent for Danish pharmaceutical giant Novo Nordisk’s blockbuster anti-obesity and
anti-diabetes drug semaglutide set to expire in March 2026, three Indian manufacturers have received approval from the Subject Expert Committee (SEC) of the central drug regulator to manufacture and market their versions, subject to regulatory conditions.
Torrent, MSN, and Natco Gain Regulatory Clearance
Among the three firms:
*Torrent Pharmaceuticals received a favorable recommendation for multiple strengths of its oral semaglutide tablets.
*MSN Laboratories secured approval for injectable vials of semaglutide in various strengths.
*Natco Pharma was granted clearance to manufacture multidose prefilled pens for semaglutide injections.
The SEC for Endocrinology and Metabolism made these decisions on January 6, 2026, under the Subsequent New Drugs (SND) division of the Central Drugs Standard Control Organisation (CDSCO). While Cipla Ltd had applied for injectable semaglutide, the company did not present its case during the meeting.
Details of Approved Formulations
MSN Laboratories presented phase III clinical trial data for semaglutide injections in strengths of 2 mg/3 ml (0.68 mg/ml), 4 mg/3 ml (1.34 mg/ml), and 8 mg/3 ml (2.68 mg/ml, synthetic origin). The SEC accepted the trial results and recommended approval, subject to post-marketing surveillance and periodic safety reporting under the NDCT Rules, 2019.
Natco Pharma submitted phase III study data for semaglutide solution in multidose prefilled pens of 2 mg/1.5 ml (1.34 mg/ml), 4 mg/3 ml (1.34 mg/ml), and 8 mg/3 ml (2.68 mg/ml, synthetic origin). The SEC granted approval with similar post-marketing conditions.
Torrent Pharmaceuticals obtained clearance for semaglutide tablets in strengths of 3 mg, 7 mg, and 14 mg (synthetic origin), also based on phase III study results.
All three formulations are indicated for adults with inadequately controlled type 2 diabetes, as an adjunct to diet and exercise. They can be used as monotherapy when metformin is unsuitable or in combination with other diabetes treatments.
Semaglutide: The Blockbuster Drug
Semaglutide, patented by Novo Nordisk, is marketed under multiple brands:
Rybelsus – oral tablets
Ozempic – injectable for diabetes
Wegovy – injectable for obesity
According to health data firm IQVIA, semaglutide ranks as the world’s second-best-selling prescription medicine, generating $26 billion in 2024 with annual growth of nearly 40%.
With the March 2026 patent expiry, Indian generics makers are racing to launch affordable versions. Companies like Sun Pharma, Dr. Reddy’s Laboratories, and Alkem already hold regulatory approvals for generics.
Market Opportunity for Indian Generics
Over 10 companies have filed SEC submissions in India to conduct Phase III trials for semaglutide, with 7 focusing on oral formulations, aiming to differentiate from injectable versions.
Systematix Institutional Equities projected in a January 2, 2026 report that semaglutide’s patent expiry could unlock over Rs. 5,000 crore in incremental revenue for generics in the next 12–15 months. The opportunity is expected to be shared among 10–15 domestic and global players:
*India: Rs. 10–20 billion
*Regulated markets (Canada, Brazil): Rs. 45 billion
*Emerging markets: Rs. 5–10 billion
The India launch could boost the Indian Pharmaceutical Market (IPM) growth by 0.5–1% in FY27, driven by higher adoption of GLP-1 therapies and lower price points—potentially 30–50% below current levels, with prices possibly dropping 70–75% over time. The GLP-1 segment is expected to remain concentrated among the top 5–10 players, including Novo Nordisk, Emcure, Sun Pharma, Eris Lifesciences, Cipla, Lupin, Torrent, Dr. Reddy’s, Alkem, and Zydus Lifesciences.
Novo Nordisk Launches Ozempic in India
Novo Nordisk launched Ozempic in India in December 2025, offering multidose pens in 0.25 mg, 0.5 mg, and 1 mg doses. The reported monthly prices are:
*0.25 mg: Rs. 8,800
*0.5 mg: Rs. 10,170
*1 mg: Rs. 11,175
As reported by pharmabiz.com, with generic alternatives poised for launch in 1QFY27, the market could witness a sharp rise in adoption due to affordable pricing and wider access.