At least 15 drugmakers have entered the race to tap an estimated ₹5,000 crore opportunity arising from the impending patent expiry of semaglutide. However, while the commercial potential is significant, experts caution that access to overseas markets will remain challenging due to stringent regulatory and intellectual property barriers.
According to a recent report by Systematix Group, the expiry of semaglutide patents across India, emerging markets (EM), and select regulated markets such as Canada and Brazil could unlock incremental revenues of over ₹50 billion for generic drugmakers over the next 12–15 months.
India and Emerging Markets Lead Near-Term Potential
The compound patent on semaglutide in India will expire in March 2026. Vishal Manchanda, Senior Vice-President (Institutional Research) at Systematix Group, said that the immediate opportunities are likely to come from India and emerging markets. “Patent expiry of semaglutide in India and EM creates meaningful headroom for generics,” Manchanda informed. He added that approvals in regulated developed markets generally take longer, particularly for peptide-based drugs.
Regulatory Markets Remain Cautious
While Canada and Brazil represent sizeable revenue pools, regulatory authorities in these markets remain cautious. “History shows that there are very few peptide generics approved in markets like Canada or Brazil,” Manchanda noted. Semaglutide, a glucagon-like peptide-1 (GLP-1) analogue developed by Novo Nordisk, is the active ingredient in blockbuster drugs such as Wegovy (for weight loss), Ozempic (for diabetes), and Rybelsus, the oral formulation for adults with type 2 diabetes.
Canada Opens Door
Canada has opened its market to generic semaglutide manufacturers from January. Foreign media reports indicate that several companies—including Apotex, Teva Pharmaceuticals, and Aspen—have already submitted applications seeking approval. However, gaining regulatory clearance remains a lengthy process, even after patent barriers ease.
Indian Players Navigate Legal and Regulatory Pathways
Among Indian drugmakers, Dr Reddy’s Laboratories (DRL) moved early by approaching local courts to secure export permissions. In December 2025, the Delhi High Court allowed DRL to export semaglutide to regions where no patent protection exists. Despite this legal clearance, DRL still awaits regulatory approval to commercially sell the drug in Canada.
Meanwhile, Sun Pharma committed to the Delhi High Court that it would not sell semaglutide in India until Novo Nordisk’s patent expires domestically. The court has, however, permitted the company to manufacture and export the drug.
Exports Limited to Regulatory Filings
Explaining the legal framework, intellectual property expert Rajeshwarie Hariharan said companies are currently allowed to export only limited quantities of semaglutide. “These exports are meant strictly for seeking regulatory approvals and not for commercial sale,” she clarified. In a significant global development, Novo Nordisk announced on December 31, 2025, that China’s Supreme People’s Court had ruled in its favour on semaglutide’s compound patent.
The Danish drugmaker said the court upheld an earlier Beijing IP Court ruling that recognised the validity of the compound patent. However, Novo Nordisk added that this decision would not change its earlier guidance. The company reiterated that patent expiry in certain countries would have only a low single-digit negative impact on its global sales growth in 2026.
Revenue Outlook Varies by Market
Systematix estimates that, in FY27, semaglutide generics could generate incremental revenues of ₹10–₹20 billion in India’s branded formulation space. Regulated markets such as Canada and Brazil could contribute around ₹45 billion, while emerging markets may add another ₹5–₹10 billion. As reported by thehindubusinessline.com, while regulated markets offer large short-term opportunities, the report cautioned that these could taper over time due to pricing pressures and competition. In contrast, India and emerging markets may see slower initial uptake but sustained growth over the long term, with comparatively lower regulatory risks.
