Larger HC Bench clears way for export of semaglutide generics by Dr Reddy's

The Delhi High Court division bench on Friday declined to interfere with a single-judge decision permitting Dr. Reddy’s Laboratories to manufacture and export the diabetes and weight-loss drug semaglutide to countries where Novo Nordisk — the maker of weight-loss drug Ozempic — does not hold a patent. Dr. Reddy’s is not allowed to sell its semaglutide formulation drugs in India until Novo Nordisk’s India patent expires in March 2026.

 

Novo Nordisk’s appeal was listed for hearing on Friday before a bench of Justice C Hari Shankar and Justice Om Prakash Shukla. The Danish pharma firm has contested the December 2 order of Justice Manmeet Pritam Singh Arora, which allowed Hyderabad-based Dr. Reddy’s to continue manufacturing and exporting the drug to non-patent jurisdictions but restrained any domestic sales until the patent’s expiry.

 

In that order, Justice Arora had refused Novo’s plea for an interim injunction blocking exports, holding that the company had not established a sufficiently strong case. The court said any financial losses Novo may incur could be compensated if it ultimately succeeds in the main trial.

 

The judge had also noted that Novo currently imports semaglutide into India and does not produce it locally, whereas Dr. Reddy’s operations were limited to exports. The court recorded Dr. Reddy’s undertaking not to sell the drug in India and directed it to furnish manufacturing and export details from April 2025, when production began. It reiterated that Dr. Reddy’s cannot market semaglutide domestically until March 2026, when Novo Nordisk’s patent lapses.

 

On December 10, the same single-judge bench extended the reasoning in Dr. Reddy’s case to Sun Pharmaceutical Industries, permitting it to manufacture and export semaglutide to non-patent countries under similar conditions, while barring domestic sales. That order came after Novo filed a separate suit to prevent Sun Pharma’s anticipated early launch of its generic version of the drug.