Sun Pharma can manufacture and export, but the Delhi High Court bars Indian sales until Novo Nordisk’s patent expires in 2026.
The Delhi High Court has handed down a closely watched order in India’s fast-heating GLP-1 drug industry, allowing major Indian multinational pharmaceutical Sun Pharma to manufacture and export its semaglutide-based weight-loss drug, but prohibiting any sale within India until March 2026, when Novo Nordisk’s secondary patent expires.
The ruling gives India’s largest drugmaker a partial green light: it may produce and ship semaglutide formulations to any country where Novo Nordisk does not hold a patent. Domestically, however, the door remains shut.
Justice Pritam Singh Arora directed Sun Pharma to submit, within two weeks, an undertaking confirming that exports will be strictly limited to non-patented markets. The company must also file quarterly statements detailing export accounts until the patent expiry date. The matter returns to court on February 19.
The dispute stems from Novo Nordisk’s efforts to protect its blockbuster GLP-1 portfolio, marketed globally as Ozempic and Wegovy for Type-2 diabetes and weight management.
GLP-1 agonists mimic a natural hormone called glucagon-like peptide-1. The drug helps regulate blood sugar, slows digestion, reduces appetite and boosts insulin release, a combination that results in significant weight loss for many patients.
Two patents underpin Novo Nordisk’s position in India:
- Patent No. 275964 (expired September 2024) – covered the basic semaglutide compound. Its expiry last year unlocked the pathway for Indian companies to explore generic versions.
- Patent No. 262697 (valid until March 2026) – covers specific formulations and delivery mechanisms that improve stability and administration.
With the base patent gone, pharma companies across India have been gearing up for a “Day 1” launch in March 2026. The court’s decision in the Sun Pharma case reinforces a pattern: companies can manufacture and export, but cannot sell domestically until the remaining patent lapses.
Novo Nordisk’s action against Sun Pharma mirrors a similar petition it filed against Indian pharmaceutical Dr Reddy’s Laboratories (DRL) [1]. Last week, the Delhi High Court refused to grant interim relief to Novo Nordisk, concluding that DRL had raised a credible challenge to the validity of the 2026 patent.
DRL remains permitted to manufacture and export its version of semaglutide, but like Sun Pharma, cannot enter the Indian market until the patent expires. The DRL ruling has been widely interpreted as a favorable signal for the broader domestic industry, including Mankind Pharma and Cipla, who are exploring GLP-1 opportunities.
The latest suit against Sun Pharma has now been transferred to the bench overseeing the DRL matter.
During the Wednesday hearing, Sun Pharma acknowledged that it is already producing semaglutide. Justice Arora reminded the company that the benefit of the December 2 DRL ruling comes with compliance obligations.
“Export to countries in which they don’t have [a] patent. That is the affidavit in that matter,” the judge said, directing Sun Pharma to file a formal confirmation [2].
Semaglutide sits at the center of a global weight-loss and metabolic-health boom. Demand for GLP-1 drugs has skyrocketed, with shortages and waitlists becoming common in many markets.
India’s weight-loss therapeutics market is small but fast-growing. The market currently offers only two Novo Nordisk products: one is Rybelsus (oral semaglutide), approved for Type-2 diabetes, and Wegovy (injectable semaglutide), which was launched in India for weight management in June 2025.
Ozempic remains unavailable in the Indian market.
Given soaring global demand, Indian companies have begun scaling peptide manufacturing capacities, partnering on injection devices and aligning regulatory strategies so they can launch generics immediately once the patent cliff hits in 2026.
The outcome of the Sun Pharma and DRL cases could form a template for how India manages the entry of generic GLP-1 drugs, a category likely to reshape the country’s metabolic-health landscape.
The stakes are high. Affordability, supply security and India’s position in the global generics market all depend on how these cases unfold. For now, Sun Pharma and other generics makers must operate in a narrow lane: manufacture, export and wait.
[1] https://spicyip.com/wp-content/uploads/2025/06/novo-nordisk.pdf
[2] https://www.barandbench.com/news/litigation/delhi-high-court-allows-sun-pharma-to-manufacture-and-export-ozempic-like-drug-but-no-sale-in-india
