Indian API Makers Gear Up For Ozempic Patent Expiry
When these patents lapse in 2026 in key markets such as Brazil, Canada, India, and China, it opens up a potentially huge opportunity for generic drug makers.
Major Indian players like Dr. Reddy's Laboratories and Macleods Pharmaceuticals are positioning themselves to supply the active pharmaceutical ingredients (APIs) required to manufacture generic versions.
APIs are the essential building blocks used to create final drug formulations for patients. Dr. Reddy's has already invested in a facility capable of producing 550 kilograms of peptides, including semaglutide. Similarly, Granules India has created a division, Ascelis Peptides, aiming to increase output of such APIs.
Smaller suppliers are also getting involved. A Surat-based manufacturer, run by Vasu Jindal, is supplying semaglutide to larger generics firms for research and development.
Although the company expects to make only about 10 kg of the API by year-end, projections for demand from next year are much higher-potentially up to 240 kg annually.
Despite the opportunity, challenges loom. Indian manufacturers will compete with Chinese firms, which currently dominate roughly 80% of global supply of generic bulk drugs. Some Indian API producers also depend on China for key chemical inputs, a vulnerability for the supply chain.
Additionally, semaglutide is structurally complex, making scaling up production and maintaining high quality in both starting materials and purification processes critical.
Industry insiders believe the early moves are strategic. By securing consistent raw materials, investing in peptide-making capacity, and preparing quality-assured processes now, India's API sector hopes to capture a substantial share of what could become a multi-billion dollar market.
(KNN Bureau)
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