At least 15 pharmaceutical companies are gearing up to tap the estimated ₹5,000 crore opportunity emerging from the impending patent expiry of semaglutide. However, while the commercial potential is significant, experts caution that expanding into foreign markets will involve complex regulatory and intellectual property hurdles.
₹50 Billion Revenue Potential Over the Next 12–15 Months
According to a recent report by the Systematix Group, the expiry of semaglutide’s patent in India, emerging markets, and select regulated markets such as Brazil and Canada could unlock incremental revenues exceeding ₹50 billion for generic drugmakers over the next 12–15 months.
In India, the compound patent for semaglutide is set to expire in March 2026. Consequently, India and emerging markets are expected to be the primary growth drivers in the near term, said Vishal Manchanda, Senior Vice-President (Institutional Research) at Systematix Group.
Regulated Markets Present Slower Pathways
In contrast, developed regulated markets typically take longer to approve peptide-based generics. Manchanda noted that regulators in these regions remain cautious, especially when it comes to complex molecules like peptides. Historically, very few peptide generics have secured approvals in markets such as Canada and Brazil, limiting immediate upside.
Semaglutide: A Blockbuster Molecule
Semaglutide, a glucagon-like peptide-1 (GLP-1) analogue developed by Novo Nordisk, forms the backbone of blockbuster drugs including Wegovy for weight loss, Ozempic for type 2 diabetes, and Rybelsus, its oral formulation for diabetes management.
Canada Opens Doors, But Approvals Remain Pending
As reported by Hindu Business Line, Canada opened its market to semaglutide generics in January, prompting several global players to file applications. Foreign media reports suggest that companies such as Apotex, Teva Pharmaceuticals, and Aspen have already submitted dossiers to regulators.
However, approvals remain pending, underscoring the cautious stance of regulatory authorities.
Indian Drugmakers Navigate Legal and Regulatory Barriers
Among Indian companies, Dr Reddy’s Laboratories (DRL) moved early by approaching local courts for permission to export semaglutide. In December 2025, the Delhi High Court allowed DRL to export the drug to countries where no patent protection exists.
Despite this legal clearance, DRL still awaits regulatory approval to commercialise semaglutide in Canada.
Similarly, Sun Pharma assured the Delhi High Court that it would not sell semaglutide in India until Novo Nordisk’s patent expires domestically. However, the company remains free to manufacture and export the drug to permitted regions.
Exports Limited to Regulatory Filings, Not Commercial Sale
Intellectual property expert Rajeshwarie Hariharan clarified that courts have allowed companies to export only limited quantities of semaglutide strictly for regulatory submissions. These exports do not permit commercial sales, ensuring that patent rights remain protected until expiry.
China Court Ruling Strengthens Novo Nordisk’s IP Position
In a parallel development, Novo Nordisk announced on December 31, 2025, that China’s Supreme People’s Court had ruled in its favour on the intellectual property rights related to the semaglutide compound patent. The court upheld an earlier decision by the Beijing IP Court affirming the patent’s validity.
Nevertheless, Novo Nordisk reiterated that patent expiries in certain countries would likely have only a low single-digit negative impact on its global sales growth in 2026.
Revenue Outlook Varies Across Markets
Looking ahead, the Systematix report estimates that semaglutide generics could generate ₹10–₹20 billion in incremental revenues in India’s branded formulations market in FY27. Meanwhile, regulated markets such as Canada and Brazil could contribute around ₹45 billion, while emerging markets may add ₹5–₹10 billion.
While regulated markets may offer a sharp initial revenue spike, the report cautions that opportunities could taper over time due to pricing pressure and competition. In contrast, India and emerging markets may grow more gradually but steadily, supported by lower regulatory risk and expanding patient access.
Balancing Opportunity with Risk
Overall, while semaglutide’s patent expiry presents a lucrative opportunity, drugmakers must balance near-term gains with regulatory complexity and commercial risk. As companies navigate this evolving landscape, success will hinge on regulatory strategy, manufacturing capabilities, and market timing.