India’s Alkem Laboratories is planning to launch a semaglutide generic drug in the country close to its patent expiration date in March, 2026, hoping to grab a pie in the lucrative diabetes and weight loss market.
Semaglutide, an active ingredient in drugs like Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026.
The multinational drug firm said that clinical trials for the GLP-1 drug were underway following regulatory approval from the Central Drugs Standard Control Organisation (CDSCO).
It aims to launch the drug close to the patent expiration date in March 2026, depending on the outcome of clinical trials and final regulatory approvals.
In a recent conversation, Alkem CEO Vikas Gupta confirmed that the company has sufficient supply chain to support the demand of semaglutide, which is used to treat type 2 diabetes and obesity.
Gupta said that while the company is currently working independently, it remains open to exploring supply chain partnerships if necessary to strengthen its market penetration.
“We are sufficiently covered at this stage. If we need to get another partner to penetrate the market more effectively, we will be open to that,” Gupta said.
Leading pharmaceutical companies, including Dr Reddy, Sun Pharma, Cipla, Mankind Pharma, Natco Pharma among others are already preparing to launch drugs in this category.
The GLP-1 class of drugs currently costs between ₹40,000 and ₹50,000 for a full month’s course. Experts point out that after patents expire, the price of the innovator drug typically falls by around 30-40 per cent, followed by a gradual decline. Eventually it settles at 75-80 per cent of the original price.
Alkem has already received approval from CDSCO to conduct Phase 3 clinical trials for semaglutide in India. CEO Gupta confirmed that the trials have commenced, and the company expects to be ready with the drug once the patent expires in March 2026, provided the clinical outcomes are positive.
“We should be ready in time, closer to the patent expiration, depending on the results of the clinical trials,” Gupta added.
The market size of semaglutide in 2024 was estimated at $27.55 billion, and it is expected to reach $50.34 billion by 2029, growing at a compound annual growth rate (CAGR) of 12.8 per cent.
Alkem is also strategically focused on the Indian market, before considering expansion into global territories. As the company believes India is going to be a big player given the nation's large obese population and the growing demand for effective anti-obesity treatments.
Alkem plans to leverage its distribution network, which spans across Tier 2 to Tier 4 cities in India, to ensure broad access to the drug. The company claims its research and development (R&D) capabilities, along with manufacturing strength, are expected to provide a competitive edge in a market, which is likely to see significant competition from other Indian pharmaceutical companies once the patent expires.
“India is a generic market, and we expect multiple players to enter the space once the patent expires. However, our wide distribution network and strong R&D capabilities will give us an advantage,” Gupta said.
While Alkem is yet to finalise the pricing strategy for semaglutide, the company aims to make the product affordable and accessible to a larger population. The pricing will depend on the cost of raw materials and market conditions closer to the launch date.
Alkem is also considering expanding its GLP-1 portfolio beyond semaglutide. The company is closely monitoring the development of other GLP-1 drugs such as tirzepatide and remains open to introducing new treatments depending on clinical outcomes and market demand.
“GLP-1 is an evolving category if new drugs show promising clinical outcomes, we would be open to adding them to our portfolio given our strength, given our presence in the space,” Gupta noted.