NATCO Pharma, Eris Lifesciences Partner to Launch Semaglutide Generic in India

NATCO Pharma has out-licensed its semaglutide generic formulation India market rights to Eris Lifesciences, with a launch expected in March 2026. NATCO Pharma recently received Central Drugs Standard Control Organisation (CDSCO) approval to manufacture semaglutide for the Indian market.

According to regulatory disclosures, NATCO has secured approval for 2mg, 4mg, and 8mg one weekly injection for the management of type 2 diabetes. The product will target type 2 diabetes management, aligning with unmet needs in India's expanding metabolic care landscape.

Semaglutide, a once-weekly GLP-1 receptor agonist, is indicated for the treatment of type-2 diabetes as an adjunct to diet and exercise, as monotherapy, when metformin is considered inappropriate due to intolerance or contraindications. Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

A GLP-1 receptor agonist, Semaglutide has emerged globally as a transformative therapy in the management of Type 2 diabetes and chronic weight management. Initially approved for type 2 diabetes, the drug gained strong clinical backing for chronic weight management, as its GLP-1–mimicking action helps curb appetite and reduce food intake in obese patients. It is an active ingredient in Novo Nordisk's weight loss drug Wegovy and diabetes drug Ozempic.

The novel peptide is Novo Nordisk's best-selling asset, generating more than $25 billion in revenue in 2025, with $20 billion from Ozempic and around $13 billion from Wegovy.

The collaboration builds on Eris's robust commercial and diabetes franchise presence and Natco's manufacturing and regulatory prowess in complex formulations. The chairman and MD stated the company had been proactively preparing its commercial strategy to participate meaningfully in the GLP-1 opportunity and views this partnership as a long-term value driver for the company.

Eris Lifesciences, which took over Biocon's India generics business—a company also developing a generic formulation—stated that its partnership covers only recombinant human insulin (RHI), glargine (long-acting insulin) and aspart (rapid-acting insulin) and it will continue to be its partner for these three products.

Both companies have kept the pricing of the partnered brand undisclosed, and Eris Lifesciences is yet to announce any plans for field force expansion, training, or marketing support for the licensed product.

In India, the molecule will lose its patent exclusivity in March this year, opening the floodgates for generics which is further expected to trigger a price drop of at least 60 per cent compared with the innovator's current branded price. Eris and Natco Pharma figure among a clutch of Indian drugmakers gearing up for the patent expiry on Semaglutide next month in the country. Alongside NATCO, several other drugmakers — such as Sun Pharma, Dr Reddy's, Alkem Laboratories and Zydus Lifesciences— have secured regulatory nod to market their respective generic brands and all are expected to hit the market on Day 1 of the first-wave opportunity.

A Natco leadership team told an investor call recently that the company is positive about Semaglutide launch though the market is expected to be extremely competitive in view of several generics. For the India market, Natco will be outsourcing the production to a fill finish source. Besides launching its own brand, Natco will be also outsourcing the product to two other entities.