The impending patent expiry of semaglutide, a blockbuster GLP-1 therapy used for diabetes and weight management, is shaping up to be a monumental opportunity for the global generic drugs market, particularly for Indian pharmaceutical companies. According to a recent ET Pharma report, the expiration of semaglutide’s patent across India, emerging economies, and select regulated markets like Canada and Brazil could unlock a revenue pool exceeding Rs. 50,000 crores for generic drugmakers over the next 12–15 months.
This seismic shift in the pharmaceutical landscape is likely to reshape competitive dynamics in metabolic and obesity treatment segments while offering patients far more affordable access to these life-changing therapies.
What Is Semaglutide and Why It Matters
Semaglutide the active ingredient in blockbuster drugs like Ozempic (for diabetes) and Wegovy (for weight management), has seen explosive demand worldwide due to its effectiveness in controlling blood sugar, reducing weight, and improving cardiometabolic outcomes.
Developed by Danish pharmaceutical giant Novo Nordisk, semaglutide has consistently generated billions in annual sales, with Wegovy alone posting multi-billion-dollar revenue figures before patent expirations loomed. Its success is tied not only to clinical benefits but also to growing global prevalence of type-2 diabetes and obesity. With the active ingredient central to both therapeutic segments, semaglutide commands a premium in markets where it is still under patent protection.
Patent Expiry: Opening the Generics Floodgates
The patent protection covering semaglutide will begin lapsing in several major jurisdictions from March 2026, a turning point that opens the field to generic competition in many regions including India, Brazil, and Canada.
In India, the initial composition patent expired in September 2024, and subsequent formulation and delivery system patents are scheduled to lapse in March 2026. These expiries remove key legal barriers that have shielded branded semaglutide products from competition, allowing domestic and international generics companies to file for regulatory approvals.
Why Indian Pharma Is Well Positioned
Indian pharmaceutical companies are among the most capable generic drug producers globally, boasting advanced manufacturing capacity, proven regulatory expertise, and competitive cost structures. Companies such as Dr. Reddy’s Laboratories, Sun Pharma, Alkem Laboratories, Zydus Lifesciences, Biocon, and others are already positioning themselves to launch generic semaglutide products as soon as regulatory approvals are secured.
Several of these players have secured regulatory approvals in India for semaglutide, and others are in the pipeline, signaling intense competition. With expected price reductions of 30–50% initially compared with branded originals, and deeper cuts possible over time, generic semaglutide is anticipated to drive broad adoption across price-sensitive markets.
Potential Challenges and Regulatory Hurdles:
Despite the promising financial prospects, bringing generic semaglutide to market is not without obstacles. Regulatory approval processes in regulated markets can be rigorous and time-consuming, requiring extensive bioequivalence and safety data. For example, Dr. Reddy’s Laboratories recently received a Notice of Non-Compliance from Canada’s drug regulator, prompting additional clarifications on its marketing application, a setback that could delay the launch there.
Furthermore, the highly competitive landscape means that only a handful of companies may capture substantial market share, while others might face pricing pressures and market fragmentation. Analysts note that generic entrants’ success will depend not just on speed to market but also on securing formulary inclusion and payer acceptance, especially in regulated healthcare systems.
Implications for Patients and Healthcare Costs:
One of the most profound impacts of semaglutide’s patent expiry will be on patient access and affordability. With generics priced substantially lower than branded versions, more patients, particularly in price-sensitive regions, could gain access to effective diabetes and weight-management treatments.
Conclusion: A Turning Point for the Pharma Industry
The expiry of semaglutide patents represents one of the most significant generics opportunities in recent years, a potential Rs. 50,000 crore revenue pool that could reshape competitive dynamics in the pharmaceutical sector. While regulatory and commercial challenges remain, Indian drugmakers and global generics firms are well poised to capitalize on this transition.
As competition intensifies and prices fall, patients stand to benefit from broader access to a therapy that has transformed diabetes and obesity treatment. At the same time, the broader industry will be watching closely as market share battles unfold across regions, regulatory landscapes evolve, and the era of affordable GLP-1 therapy dawns.
Source - ETPharma
