Novo Nordisk gets US FDA approval for higher-dose Wegovy, as India's generic Semaglutide war begins
Semaglutide went off patent in India on March 20, immediately drawing in generic manufacturers with prices starting as low as Rs 220 a shot. A day earlier, Novo Nordisk had secured US FDA approval for a higher-dose Wegovy delivering 20.7% mean weight loss that none of its new Indian rivals can currently match
- Mar 20, 2026,
- Updated Mar 20, 2026 6:42 PM IST
The day before semaglutide went off-patent in India, Danish drug maker Novo Nordisk got US Food and Drug Administration approval for a higher-dose version of Wegovy, its blockbuster weight loss drug that generic manufacturers are not yet positioned to match. The announcement comes at a time when its original semaglutide molecule faces generic competition in India and other markets.
The new formulation, Wegovy HD, contains semaglutide at 7.2 mg, compared to the 2.4 mg dose in the existing Wegovy injection. The FDA approval came on March 19, 2026, and the company expects to launch the product in the US in April.
In the STEP UP clinical trial, Wegovy HD demonstrated a mean weight loss of 20.7% in participants with obesity over 72 weeks. Around one in three patients achieved 25% or greater weight loss. In a separate trial involving patients with both obesity and type 2 diabetes, the mean weight loss was 14.1%. The company said the safety and tolerability profile was consistent with earlier semaglutide trials.
The approval was granted under the FDA Commissioner's National Priority Voucher pilot programme, which accelerates review for products addressing critical national health priorities in the US. Novo Nordisk said this was the first GLP-1 treatment to receive approval under this programme.
Wegovy HD is already approved in the European Union and the United Kingdom. Novo Nordisk said it expects regulatory decisions on a single-dose pen version in both markets in the second half of 2026.
Semaglutide's patent expired in India on March 20, 2026, opening the market to an estimated 40-plus generic manufacturers. To defend its position in the anti-obesity market, Novo Nordisk has responded on multiple fronts, cutting prices on existing Wegovy doses in India by up to 37% in November 2025, partnering with Emcure to bring another semaglutide brand to the Indian market, and now moving to a higher-dose formulation that generics cannot replicate immediately.
Wegovy HD uses a dose strength that is not part of the standard semaglutide patent being challenged by Indian generics manufacturers. In India, Wegovy currently costs between Rs 10,850 and Rs 16,400 per month depending on the dose, after the November 2025 price cut.
The company also noted that a once-daily oral version of Wegovy has already been launched in the US this year, giving it three distinct semaglutide-based offerings in the weight management space, a pill, a standard injectable and now a high-dose injectable.
"Since its launch in 2021, Wegovy has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk," said Mike Doustdar, president and CEO of Novo Nordisk.
"Earlier this year, we launched the Wegovy pill, and with the accelerated approval of Wegovy HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy HD to help even more people reach their weight and health goals."
On the same day as the patent expiry, Natco Pharma and Eris Lifesciences announced the launch of generic semaglutide in India. Natco is entering with a multi-dose vial format under the brands Semanat and Semafull, priced at Rs 1,290 per month for lower strengths and Rs 1,750 for the highest strength, approximately 90% lower than the innovator product. Eris is marketing its version under the brand name SUNDAE at Rs 220 per shot, with a pen device version expected in April priced between Rs 4,000 and Rs 4,500 per month depending on dose strength.
The broader GLP-1 market continues to grow rapidly. Novo Nordisk's combined revenues from Ozempic and Wegovy crossed $26 billion in 2024. According to Eli Lilly's full year 2024 results, Mounjaro and Zepbound together posted combined sales of $16.47 billion. According to Goldman Sachs Research, the global anti-obesity drug market is projected to reach $95 billion by 2030.
The day before semaglutide went off-patent in India, Danish drug maker Novo Nordisk got US Food and Drug Administration approval for a higher-dose version of Wegovy, its blockbuster weight loss drug that generic manufacturers are not yet positioned to match. The announcement comes at a time when its original semaglutide molecule faces generic competition in India and other markets.
The new formulation, Wegovy HD, contains semaglutide at 7.2 mg, compared to the 2.4 mg dose in the existing Wegovy injection. The FDA approval came on March 19, 2026, and the company expects to launch the product in the US in April.
In the STEP UP clinical trial, Wegovy HD demonstrated a mean weight loss of 20.7% in participants with obesity over 72 weeks. Around one in three patients achieved 25% or greater weight loss. In a separate trial involving patients with both obesity and type 2 diabetes, the mean weight loss was 14.1%. The company said the safety and tolerability profile was consistent with earlier semaglutide trials.
The approval was granted under the FDA Commissioner's National Priority Voucher pilot programme, which accelerates review for products addressing critical national health priorities in the US. Novo Nordisk said this was the first GLP-1 treatment to receive approval under this programme.
Wegovy HD is already approved in the European Union and the United Kingdom. Novo Nordisk said it expects regulatory decisions on a single-dose pen version in both markets in the second half of 2026.
Semaglutide's patent expired in India on March 20, 2026, opening the market to an estimated 40-plus generic manufacturers. To defend its position in the anti-obesity market, Novo Nordisk has responded on multiple fronts, cutting prices on existing Wegovy doses in India by up to 37% in November 2025, partnering with Emcure to bring another semaglutide brand to the Indian market, and now moving to a higher-dose formulation that generics cannot replicate immediately.
Wegovy HD uses a dose strength that is not part of the standard semaglutide patent being challenged by Indian generics manufacturers. In India, Wegovy currently costs between Rs 10,850 and Rs 16,400 per month depending on the dose, after the November 2025 price cut.
The company also noted that a once-daily oral version of Wegovy has already been launched in the US this year, giving it three distinct semaglutide-based offerings in the weight management space, a pill, a standard injectable and now a high-dose injectable.
"Since its launch in 2021, Wegovy has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk," said Mike Doustdar, president and CEO of Novo Nordisk.
"Earlier this year, we launched the Wegovy pill, and with the accelerated approval of Wegovy HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy HD to help even more people reach their weight and health goals."
On the same day as the patent expiry, Natco Pharma and Eris Lifesciences announced the launch of generic semaglutide in India. Natco is entering with a multi-dose vial format under the brands Semanat and Semafull, priced at Rs 1,290 per month for lower strengths and Rs 1,750 for the highest strength, approximately 90% lower than the innovator product. Eris is marketing its version under the brand name SUNDAE at Rs 220 per shot, with a pen device version expected in April priced between Rs 4,000 and Rs 4,500 per month depending on dose strength.
The broader GLP-1 market continues to grow rapidly. Novo Nordisk's combined revenues from Ozempic and Wegovy crossed $26 billion in 2024. According to Eli Lilly's full year 2024 results, Mounjaro and Zepbound together posted combined sales of $16.47 billion. According to Goldman Sachs Research, the global anti-obesity drug market is projected to reach $95 billion by 2030.