India Pharma Outlook Team | Wednesday, 12 August 2026
The oral semaglutide race in India has hit a fresh legal hurdle. The Delhi High Court has asked Sun Pharma to seek its approval before launching the tablets.
The order follows a patent infringement plea filed by Danish drugmaker Novo Nordisk. The company claims patent protection for the tablet form of semaglutide.
The case could affect the timing of Sun Pharma's planned entry into India's growing GLP-1 drug market. It also highlights the patent challenges facing Indian drugmakers entering this market.
Justice Anup Jairam Bhambhani directed Sun Pharma Laboratories to seek court approval before launching its tablets. The direction will apply if the company receives a license for commercial manufacturing. Sun Pharma must then inform the court before taking steps to launch the product.
The court has also sought Sun Pharma's response to Novo Nordisk's patent infringement petition. Novo Nordisk claims Sun Pharma's proposed tablets could violate its patent rights. The company has sought a restraint order against the launch.
Novo Nordisk argued that Sun Pharma could launch soon after receiving marketing approval. It also said withdrawing the product later could prove difficult.
Sun Pharma has already received approval from the subject expert committee for manufacturing tablets in three strengths:
The dispute now puts the commercial launch under closer court scrutiny.
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Semaglutide is used in diabetes and weight-management treatments. Its oral form could make treatment more convenient than injectable options. The patent dispute comes as Indian drugmakers prepare to enter the semaglutide market. The expiry of key patent protection has opened opportunities for lower-cost versions.
However, different patents can cover different forms or formulations of the same drug. That distinction is central to the current dispute. Novo Nordisk says its latest patent covers semaglutide tablets. It also pointed out that its primary patent for the injectable version expired in India in March.
Sun Pharma has challenged Novo Nordisk's position on several grounds. The company argued that the Delhi High Court lacks territorial jurisdiction because Sun Pharma is based in Maharashtra. It also said Novo Nordisk must establish similarity between the products.
Sun Pharma further argued that its product was being compared against an expired patent. Novo Nordisk countered that Sun Pharma Laboratories has a Delhi address and conducts business there. It also sells products through online and offline channels in Delhi.
The company said Sun Pharma could sell the semaglutide tablets in Delhi after receiving approval.
The legal battle comes as competition in India's semaglutide market is expected to intensify. Indian drugmakers are looking to offer more affordable versions of popular diabetes and obesity medicines. The entry of generics could create stronger price competition in the market.
For Sun Pharma, the immediate issue is whether it can move from regulatory approval toward commercial launch. For Novo Nordisk, the case is about protecting patent rights around its oral formulation.
The court's latest direction does not settle the patent dispute. It places an additional step before any potential Sun Pharma launch. The outcome could therefore have wider implications for India's oral GLP-1 market and competition among pharmaceutical companies.
