Delhi court tells Sun Pharma to seek approval before launching semaglutide tablets

The Delhi High Court has directed Sun Pharma Laboratories to seek the court's approval before it commercially manufactures or launches semaglutide tablets in India, in a patent infringement suit brought by Novo Nordisk A/S ^[1].

The order, issued by Justice Anup Jairam Bhambhani, is dated 11 August 2026. The court declined to grant Novo Nordisk an interim injunction at this stage. Instead it said: "As and when a manufacturing license is granted to the defendant for the manufacture of Semaglutide Tablets, before taking any steps towards commercial manufacturing or launch of the said product, the defendant shall move an appropriate application before this court seeking prior approval for that purpose." ^[1]

Novo Nordisk argued that Sun Pharma's proposed semaglutide tablets, in 3 mg, 7 mg and 14 mg dosages, would infringe its patent. It pointed to recommendations made by the Subject Expert Committee at a meeting on 24 June 2026, which recommended permission for Sun Pharma to manufacture and market the tablets ^[1]. Novo Nordisk's lawyer, Senior Counsel Amit Sibal, told the court that Sun Pharma had completed clinical trials and was on the verge of launching the drug ^[1].

Sun Pharma's lawyer, Senior Counsel Rajeshwari Hariharan, raised a preliminary objection that the Delhi High Court lacked territorial jurisdiction because none of the parties is based in Delhi. She also argued the suit was premature, since Sun Pharma had not yet applied for a commercial manufacturing license, a process she said would take time ^[1]. The court kept the jurisdiction objection open for a later stage ^[1].

The court also noted what it described as ambiguity in Sun Pharma's position on the composition of its product: "It appears there is ambiguity as to the defendant's stand, in particular as to whether their pharmaceutical product contains Salt of NAC alongwith Semaglutide; and if so, in what proportion/range; and whether the quantity of SNAC contained in the defendant's product maps onto the plaintiffs' patent claim(s)." ^[1]

The case is one of several disputes in India over semaglutide, the molecule in Novo Nordisk's Ozempic, Wegovy and Rybelsus ^[2]. Novo Nordisk's product patent in India, IN262697B, expired on 20 March 2026. Before that, the Delhi High Court allowed Dr. Reddy's Laboratories to produce and export semaglutide while limiting domestic sales until the patent expired, and Torrent Pharmaceuticals effectively got a green light to enter the market hours before the patent lapsed, with no injunction issued ^[2]. Novo Nordisk's remaining leverage in India rests largely on formulation patents, including IN 325669, which covers the absorption enhancer SNAC and is valid until 2031 ^[2].

Why it matters for patients

The case concerns semaglutide tablets, not the injectable forms of the drug. It is being heard in India and applies to the Indian market. Nothing in the order changes what is available or covered in the United States, where semaglutide products are sold under separate approvals and patents. No effect on US supply, pricing or insurance coverage has been reported.

For patients in India, the order does not block a copy version of oral semaglutide outright. It adds a step: Sun Pharma must ask the court before it starts commercial manufacturing or launch, and the court will then consider Novo Nordisk's request for interim relief ^[1]. Sun Pharma said it had not yet applied for a commercial manufacturing license, and the timeline for licensing has not been disclosed ^[1].

The case also shows how formulation patents can outlast a main product patent. SNAC, the absorption enhancer covered by a patent valid to 2031, is central to how oral semaglutide is absorbed ^[2]. Generic makers trying to sell tablets after 2026 may still face claims over that ingredient, and whether Sun Pharma's product contains SNAC in a way that overlaps with Novo Nordisk's patent claims is exactly what the court said remains unclear ^[1].

What happens next

The matter is next listed before the Joint Registrar on 4 November 2026 ^[1]. The court has said it will consider Novo Nordisk's plea for interim relief after Sun Pharma files an application seeking approval to commercially manufacture or launch the product ^[1]. Whether Sun Pharma has filed that application, and when any launch might happen, has not been reported.