Natco Pharma Receives Approval for Generic Semaglutide in India, Launch Planned for March

Natco Pharma Ltd. has received government approval to manufacture and market generic semaglutide injection in India, with the company planning to launch the product in March 2026. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, granted the authorization on February 14, 2026.

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, serving as an adjunct therapy alongside diet and exercise modifications. The drug, a glucagon-like peptide-1 (GLP-1) receptor agonist, is approved by the US Food and Drug Administration as three separate brand name medications: Ozempic, Wegovy, and Rybelsus. It works by helping the pancreas release a fair amount of insulin when blood glucose levels are high. Insulin directs the muscle and fat cells to take in glucose, which is utilised for energy.

The regulatory clearance arrives amid ongoing patent litigation. Natco Pharma has filed a suit before the Delhi High Court seeking the revocation of Novo Nordisk's Indian patent (IN 262697) for semaglutide formulations, a patent set to expire in March 2026. This mirrors a similar challenge initiated by Dr. Reddy's Laboratories, which argued that Novo Nordisk's patents might constitute "evergreening." The Delhi High Court has previously indicated that challenges to Novo Nordisk's patents by Dr. Reddy's and Sun Pharmaceutical Industries are credible, allowing these entities to manufacture and export semaglutide to non-patent jurisdictions while restraining domestic sales until the patent expiry.

The Indian pharmaceutical sector is preparing for a significant influx of generic semaglutide. Sun Pharmaceutical Industries, Zydus Lifesciences, Alkem Laboratories, and Dr. Reddy's Laboratories have also secured approvals for generic semaglutide. Torrent and MSN gained favorable recommendations from the Subject Expert Committee (SEC) of CDSCO. In India, the molecule will lose its patent exclusivity in March, opening the floodgates for generics which is expected to trigger a price drop of at least 70 per cent compared with the innovator's current branded price.

Senior executives told analysts during the third quarter earnings concall that the Indian semaglutide market is expected to be highly competitive with many generics, where Natco will launch its own brand and out-license to two other companies. Semaglutide is projected to be the primary driver for the domestic business, targeting over 20% growth, with 350-400 medical representatives allocated for promotion. In the US, no competitor has FDA approval for semaglutide within 30 months, and Natco Pharma holds sole First-To-File (FTF) exclusivity for significant strengths of both Ozempic and Wegovy, with Ozempic already settled.

The Indian semaglutide market generated $25.8 million in 2024 and is forecasted to reach $347.5 million by 2035, with a compound annual growth rate of 17.8%. In India, the anti-obesity drug market has quadrupled in five years to ₹576 crore as of March 2025, driven by GLP-1 drugs, which account for 75% of the market value. The global market for weight-loss drugs is projected to reach $150 billion by the end of the decade, with GLP-1 receptor agonists like semaglutide leading the charge.

Novo Nordisk's semaglutide franchise generated an estimated $33 billion in 2025 and is projected at $36 billion for 2026. The company's Ozempic and Wegovy generated DKK 215 billion in 2023 for its Diabetes and Obesity Care segment.

Shares of Natco Pharma closed down 2.13% on Friday at ₹822.10, compared to a 1.25% fall in the benchmark BSE Sensex. The company's stock had surged as much as 10.95% to hit an intraday high of ₹914 on the National Stock Exchange (NSE) following the approval announcement. The company's market capitalization stands at approximately ₹14,700 crore. Its trailing twelve months (TTM) Price-to-Earnings (P/E) ratio is around 9.5x. Analysts maintain a 'Neutral' consensus rating for Natco Pharma, with an average 12-month price target of ₹970.36, suggesting a potential upside of over 15%.

Hyderabad-based Natco Pharma develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The company operates 9 manufacturing sites and 2 R&D facilities in India, holding approvals from major global regulatory bodies, including the U.S. FDA and Health Canada, servicing over 50+ global markets.