Delhi High Court orders Sun Pharma to seek approval before launching semaglutide tablets

The Delhi High Court has ordered Sun Pharma Laboratories to seek prior approval from the court before it commercially manufactures or launches its semaglutide tablets, in a patent suit brought by Novo Nordisk ^[1]. Justice Anup Jairam Bhambhani issued the direction on August 11 but stopped short of granting Novo Nordisk an interim injunction at this stage ^[1].

The case centers on Sun Pharma's proposed tablets in 3 mg, 7 mg and 14 mg doses, which Novo Nordisk says would infringe its patents ^[1]. Sun Pharma has not yet obtained a commercial manufacturing licence for the product, and the court said that once such a licence is granted, Sun Pharma must file an application asking the court for approval before taking any steps toward launch ^[1]. The judge pointed to unresolved questions about the tablet's makeup, writing that it was unclear whether Sun Pharma's product contains SNAC, an absorption-enhancer ingredient, alongside semaglutide, and whether the amount used would fall within Novo Nordisk's patent claims ^[1].

This dispute is one of several playing out in India since Novo Nordisk's core product patent on semaglutide, IN262697B, expired on March 20, 2026 ^[2]. That expiry opened the door for Indian generic makers, and Torrent Pharmaceuticals was allowed to launch its own semaglutide products, Sembolic and Semalix, just hours before the patent lapsed, after the Delhi High Court declined to grant Novo Nordisk an injunction in that case too ^[2]. Dr. Reddy's Laboratories had earlier been permitted by the same court to manufacture and export semaglutide, with domestic sales allowed only after the March 2026 expiry ^[2].

With the core product patent gone, Novo Nordisk's remaining legal tool in India is largely a separate formulation patent covering SNAC, the ingredient that helps the body absorb oral semaglutide, which is valid until 2031 ^[2]. In the Torrent case, Novo Nordisk argued that Torrent's product infringed this SNAC patent even though the underlying semaglutide molecule patent had expired ^[2]. In the Sun Pharma case, the same SNAC composition question is now central to whether an injunction will eventually be granted ^[1].

Sun Pharma's lawyers argued the Delhi court lacks jurisdiction because neither company is based in Delhi, and that the suit is premature since Sun Pharma has not yet applied for a manufacturing licence ^[1]. The court left the jurisdiction question open for later and said it would revisit Novo Nordisk's request for interim relief once Sun Pharma actually applies to launch ^[1]. The case is next scheduled before the Joint Registrar on November 4, 2026 ^[1].

Why it matters for patients

This case is unfolding in India, not the United States, and it does not change what is approved or available at US pharmacies. But it matters to American readers who follow the global GLP-1 supply picture, because India is a major source of generic drug manufacturing, and how these formulation-patent fights resolve could shape future global competition and pricing once molecule patents expire elsewhere, including eventually in the US ^[1][2].

The broader pattern also shows that even after a core patent expires, drugmakers can still use narrower formulation patents, like the one covering SNAC, to slow down or contest generic launches ^[2]. Indian courts have so far been reluctant to block generic entry late in a patent's life when the underlying patent's validity or scope is in dispute, which has repeatedly gone against Novo Nordisk in cases involving Torrent and Dr. Reddy's ^[2]. Whether that same caution applies to Sun Pharma remains open, since the court has not yet ruled on the merits of the SNAC infringement question ^[1].

What happens next

The Sun Pharma matter returns to a Joint Registrar on November 4, 2026 ^[1]. The court has said it will only consider Novo Nordisk's request for an injunction after Sun Pharma obtains a manufacturing licence and formally applies to launch ^[1]. Until then, whether or how soon Sun Pharma's tablets reach the Indian market is not yet known ^[1].