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

Notably, semaglutide is the compound behind the Danish drugmaker’s blockbuster weight-loss drug Ozempic.

The order, released on Wednesday evening and reviewed by Mint, rejected Novo Nordisk’s plea to restrain Dr. Reddy’s from manufacturing and exporting the drug.

The bench of Justice Manmeet Pritam Singh Arora held that Novo had not established a strong enough case to justify an interim ban and noted that any financial losses could be compensated later if Novo ultimately succeeds after the full trial.

“Accordingly, the plaintiff (Nova) has failed to make out a prima facie case for the grant of an interim injunction… any damages suffered by the plaintiff can be adequately compensated after the trial," the order states.

The ruling observed that Novo only imports semaglutide into India and does not manufacture it locally. On that basis, the court permitted Dr. Reddy’s to continue production and export.

“Since the plaintiff is not manufacturing in India and only importing to India, this Court accepts the undertaking by the defendants and permits them to manufacture the impugned drug in India and export it to countries where the plaintiff does not have a patent registration," the judgment noted.

The court found that Dr. Reddy’s had raised a credible challenge to Novo’s patent, pointing out that semaglutide had already been disclosed in an earlier 2004 patent, raising concerns regarding novelty and whether the later patent represented an attempt to extend monopoly protection.

The court also recorded Dr. Reddy’s undertaking that it will not sell semaglutide in India, permitting only exports, and directed the company to place on record the manufacturing and export details since April, when production began.

However, the court clarified that Dr. Reddy’s cannot sell the drug in India until the patent expires in March 2026, noting that the company began manufacturing in April but did not challenge Novo’s patent until 12 March, doing so at its own risk.

The judge also clarified all observations are prima facie and will not influence the final outcome of the trial.

The development is expected to have significant implications for India’s generic drugmakers, which are raring to enter the fast-growing anti-obesity drug market.

On the patent’s expiry, several Indian drugmakers, including DRL, Sun Pharma, Mankind Pharma and Natco Pharma, plan to launch cheaper generics of the drug, according to company statements.

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

The background

At the centre of the dispute between Novo Nordisk and Dr Reddy’s is semaglutide’s patent structure. The primary composition patent for the molecule, held by Novo, expired in September 2024, opening the door to generic competition.

However, Novo still holds a formulation patent covering delivery mechanisms meant to improve stability, valid until March 2026.

Dr Reddy’s has challenged this under Section 64 of the Patents Act, calling it an attempt at “evergreening" to extend monopoly protection. The company argues it secured regulatory approval in December 2024 to manufacture semaglutide solely for export, claiming protection under India’s Bolar exemption (Section 107A), which permits export of patented drugs to countries where patents have expired.

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

On 12th May, Dr Reddy’s challenged the validity of Novo’s second patent in the Delhi High Court, saying that it lacks novelty. Soon after, Novo Nordisk filed a patent infringement suit against Dr Reddy’s and its contract manufacturer, OneSource Specialty Pharma, accusing them of attempting to manufacture and market semaglutide formulations without a licence.

On 29 May, Justice Amit Bansal barred Dr. Reddy’s from selling semaglutide in India, but allowed the company to manufacture and export it until the case is finally decided. In July, Novo Nordisk filed an appeal against the May order.

Novo then appealed to a division bench, seeking clarity on how long export would be allowed. On 23 July, the division bench sent the issue back to the single bench to decide specifically on exports.

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

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

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 obesity treatment, with studies showing patients could lose 15-23% of body weight. The drug mimics the GLP-1 hormone, signalling fullness to the brain, slowing digestion, and reducing cravings.

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

Novo introduced Wegovy in India in June, priced initially between ₹17,345 and ₹26,050 a month. The launch coincided with a surge in demand for obesity treatments.

India’s anti-obesity drug market has jumped from ₹133 crore in March 2021 to ₹576 crore in March 2025, according to PharmaTrac data, with semaglutide contributing about ₹397 crore.

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

The latter has rapidly overtaken Wegovy, becoming the top-selling brand in October with ₹100 crore in monthly sales, nearly 10 times Wegovy’s revenue, data from research firm Pharmarack showed. Mounjaro is priced between ₹14,000 and ₹27,500 a month.

Facing competitive pressure, Novo cut Wegovy prices by 37% in November, reducing the entry-level dose to ₹10,850.