Aniket PujariNotably, semaglutide is the compound behind the Danish drugmaker’s blockbuster weight-loss drug Ozempic.
A single-judge bench of Justice Manmeet Singh Arora noted prima facie merit in Dr Reddy’s petition challenging the validity of Novo Nordisk’s patent, according to two lawyers close to the development, who requested anonymity.
“This is a significant development as that forms the basis to not grant relief 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 has been released.
While the final written order of the court had not been released till press time, the two lawyers confirmed that Dr Reddy’s can manufacture semaglutide domestically and export to countries where Novo Nordisk does not hold patent protection.
It cannot export until March 2026 to countries where the patent expires that month. In India, too, the patent expires in March 2026, which means the company is barred from selling domestically till then.
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.
