In a setback to Sun Pharma’s push into the fast-growing weight-loss and diabetes drug market, the Delhi High Court on Tuesday directed the company to seek the court’s approval before launching semaglutide tablets, following a patent infringement suit filed by the innovator, Novo Nordisk.
The Danish drugmaker lost patent exclusivity for semaglutide in March, the compound behind injectables like Ozempic and Wegovy, which saw a rush of copycat generics being launched in India. However, Novo Nordisk’s oral semaglutide, Rybelsus, is protected by a separate formulation patent, which it claims Sun has infringed. Novo has pursued a similar suit against Torrent Pharma over semaglutide tablets.
The generic semaglutide market continues to grow steadily, driven by intense competition among domestic players. In July, oral semaglutide also saw a significant uptick, driven by generics, according to data from Pharmarack.
After hearing the matter for more than two hours, Justice Anup Bhambani directed Sun Pharma that if and when it receives a commercial manufacturing licence, it must file an application before the court before taking any further steps to launch the drug. The court will then decide whether any further orders are required.
“If and when a manufacturing license is granted to them (Sun Pharma) for the manufacture…the defendants (Sun Pharma) shall move an application before the court, at which stage the court may consider if any further orders are required to be passed,” judge Anup J. Bhambhani said in an oral order.
Queries sent to Sun Pharma and Novo Nordisk were not answered till press time.
Senior counsel Amit Sibal, appearing for Novo Nordisk, argued that Sun Pharma's proposed product could infringe its patent on an oral semaglutide formulation that uses Salcaprozate sodium (SNAC), a compound that aids the absorption of large drug molecules in the stomach.
Sibal also pointed out that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has approved Sun Pharma for the permit to manufacture semaglutide tablets. “The moment they get the marketing approval, they will launch,” Sibal told the court, arguing that this created an ‘imminent threat’ to Novo’s patent.
Opposing the plea, Sun Pharma argued that the Delhi High Court should not hear the case because the company is based in Mumbai and does not yet have a manufacturing licence for the proposed drug.
The Sun Pharma counsel also added that SEC approval is not the final marketing approval; the company must obtain other regulatory licenses before it can manufacture and sell the drug.
The court said it was concerned about the ‘ambiguity’ over the composition that Sun Pharma has proposed for its product.
Sun Pharma is currently the second-largest generic semaglutide player in the domestic market, after Torrent. Meanwhile, Novo Nordisk is desperately trying to hold on to its market share against the generic onslaught by reducing costs and banking on its doctor outreach.
In July, sales of semaglutide injectables by generic drugmakers were at ₹46 crore, while Novo Nordisk's sales totalled ₹27 crore, according to Pharmarack. For oral semaglutide, Novo Nordisk reported ₹20 crore in sales, while generic tablet sales stood at ₹11 crore. However, generic tablets have seen a pickup in sales over the past month, while Novo has remained largely flat, according to data from Pharmarack.
In March 2026, Novo Nordisk approached the Delhi High Court to block Dr. Reddy’s from launching a generic version of semaglutide under the brand name ‘Olymviq’, arguing that it is phonetically and structurally similar to Ozempic and risks confusing patients and prescribers.