Torrent Pharmaceuticals is preparing to launch both oral and injectable forms of semaglutide in India after Novo Nordisk’s patent expires in March 2026. The move positions Torrent as a leading player in the upcoming GLP-1 generics market.
✔️ Phase III Trials Approved
Torrent secured regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) to begin Phase III clinical trials for semaglutide tablets (3 mg, 7 mg, and 14 mg) in April 2025. The trials are a crucial step toward gaining marketing authorization after the patent expiry.
📄 Torrent gets CDSCO nod for semaglutide Phase III trial – Medical Dialogues
🧬 Patent Expiry Sparks Race Among Generics
Novo Nordisk’s semaglutide patent is set to expire in India by March 2026. This has opened doors for Indian pharma companies to enter the diabetes and obesity drug segment, currently dominated by Ozempic and Wegovy.
🏭 Government Support via PLI Scheme
To boost local manufacturing, the Indian government plans to introduce a production-linked incentive (PLI) scheme starting in 2026. The initiative aims to encourage domestic firms to produce GLP-1 class drugs, including semaglutide.
⚖️ Legal Hurdles for Early Launches
Despite growing interest, companies like Dr. Reddy’s and OneSource Specialty Pharma face legal barriers. Novo Nordisk has filed patent infringement suits in Indian courts to block early entry. The Delhi High Court has restricted domestic sales of semaglutide by these firms pending further hearings.
⚖️ Delhi High Court action on semaglutide generics – LawyersArc
🏁 Competition Heats Up
Apart from Torrent, major Indian pharma companies including Sun Pharma, Cipla, Zydus Lifesciences, Aurobindo Pharma, Natco, Lupin, and Biocon are actively exploring opportunities in the GLP-1 space.
- Dr. Reddy’s aims to launch semaglutide in 87 countries by 2026.
- Biocon targets approvals in India and Canada by late 2026.
📦 Delivery Devices in Demand
Companies producing injection pens and delivery devices, such as Shaily Engineering Plastics, are scaling operations to meet growing demand for semaglutide delivery systems.
📌 Key Highlights
- Patent expiry in March 2026 opens Indian market for semaglutide generics.
- Torrent’s Phase III trials approved for oral formulations.
- PLI incentives to support local GLP-1 production.
- Legal battles delay some competitors from launching early.
- India’s pharma giants eyeing a share of the $150 billion global GLP-1 market.