Dr Reddy’s wins Delhi HC nod to export semaglutide to non-patent markets

Semaglutide, in particular, is the compound behind the Danish drugmaker’s blockbuster weight-loss drug Ozempic.

Single-judge bench of Justice Manmeet Singh Arora According to two lawyers familiar with the development who wished to remain anonymous, Dr. It was stated that Reddy’s petition challenging the validity of Novo Nordisk’s patent was prima facie justified.

“This is an important development because it forms the basis for denying aid to Novo Nordisk,” one of the lawyers told Mint.

Both Dr Reddy’s and Novo Nordisk declined to comment on the development until the official order is issued.

Although the court’s final written decision was not published by press time, two lawyers confirmed that Dr Reddy’s could produce semaglutide domestically and export to countries where Novo Nordisk does not have patent protection.

Exports cannot be made until March 2026 to countries where the patent expires in that month. In India, too, the patent expires in March 2026, meaning the company is prohibited from selling domestically until then.

The development is expected to have significant impacts on India’s generic products. drug manufacturers eager to enter the rapidly growing anti-obesity drug market.

According to company statements, once the patent expires, many Indian drug manufacturers, including DRL, Sun Pharma, Mankind Pharma and Natco Pharma, are planning to launch cheaper generics of the drug.

Meanwhile, Novo has tied up with Pune-based Emcure Pharmaceuticals to distribute the drug under the brand name Poviztra in India, aiming for deeper penetration beyond metros.

Background

Novo Nordisk and Dr. Semaglutide’s patent structure is at the heart of the dispute between Reddy’s. Novo’s primary composition patent for the molecule expired in September 2024, opening the door to generic competition.

However, Novo still holds a formulation patent valid until March 2026 that covers delivery mechanisms intended to improve stability.

Dr Reddy’s opposed it under Section 64 of the Patents Act, calling it an “evergreen” attempt to extend monopoly protection. The company claims to have received regulatory approval in December 2024 to produce semaglutide for export only, seeking protection under India’s Bolar exemption (Section 107A), which allows export of patented drugs to countries where patents have expired.

Novo rejects this view, citing Section 48, which gives the patentee exclusive rights to make, use, sell and export the invention and argues that exports cannot be used to bypass an active patent.

On May 12, Dr. Reddy challenged the validity of Novo’s second patent in the Delhi High Court, saying it lacked innovation. Shortly afterwards, Novo Nordisk filed a patent infringement lawsuit against Dr Reddy’s and its contract manufacturer, OneSource Specialty Pharma, accusing them of attempting to manufacture and market semaglutide formulations without a licence.

Justice Amit Bansal banned on May 29 Dr. Reddy sells semaglutide in India but has allowed the company to manufacture and export semaglutide until the case is finally decided. In July, Novo Nordisk appealed the May decision.

Novo then approached a departmental panel and sought clarity on how long exports would be allowed. On July 23, the division bench sent the matter back to the single bench for decision, especially on exports.

On Tuesday, Justice Manmeet Pritam Singh Arora, Dr. It ruled that Reddy’s could continue exporting semaglutide until March, but the ban on sales in India remains.

Meanwhile, in August, Natco Pharma also filed an infringement suit in the Delhi High Court, claiming that its version does not infringe Novo’s patents and should be allowed to enter the market. The matter is currently in the mediation stage.

What is semaglutide?

Semaglutide, the active ingredient in Novo Nordisk’s GLP-1 drugs (Ozempic, Wegovy, and Rybelsus), was originally developed for type 2 diabetes and later approved for the treatment of obesity; Studies have shown that patients can lose 15-23% of their body weight. By mimicking the GLP-1 hormone, the drug signals satiety to the brain, slows down digestion and reduces appetite.

Semaglutide was developed by Novo around 2012, approved as Ozempic in 2017, and relaunched at a higher dose in 2021 as Wegovy.

Novo launched Wegovy in India in June. ₹17,345 and ₹26,050 per month. The launch coincided with rising demand for obesity treatments.

India’s anti-obesity drug market jumps ₹133 crore in March 2021 ₹576 crore in March 2025, according to PharmaTrac data, semaglutide’s contribution is approx. ₹397 crore.

India’s weight loss drug market is currently dominated by Novo’s semaglutide series and tirzepatide, sold by Eli Lilly as Mounjaro.

The second is quickly left behind Wegovy became the best-selling brand of October ₹100 crore in monthly sales, almost 10 times Wegovy’s revenue, according to data from research firm Pharmarack. Price of Mounjaro ₹14,000 and ₹27,500 per month.

Faced with competitive pressure, Novo cut its Wegovy prices by 37% in November to increase its entry-level dose. ₹10,850.