Novo Nordisk's blockbuster drug Ozempic's India launch is imminent, so are its generic versions

On September 26, Danish pharma multinational Novo Nordisk got the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO)’s approval to sell its global blockbuster diabetes medicine Semaglutide (known under the brand name Ozempic) in India.

Ozempic, a once-weekly injection for the treatment of type 2 diabetes, had garnered about $ 17 billion in global sales in 2024, to remain the world’s biggest-selling diabetes medicine last year.

The company is yet to announce Ozempic’s launch date in India. However, in a response to a query from Fortune India, it said the highly anticipated launch can be expected soon.

"India is a key market for Novo Nordisk, and we strive to introduce the best-in-class innovations for the people who need it the most. At the same time, we are dedicated to improving access and affordability, so that more patients can benefit from our therapies and achieve better health outcomes”, Vikrant Shrotriya, Managing Director, Novo Nordisk India, said.

Once introduced, Novo Nordisk will have its complete semaglutide portfolio in India, providing a range of treatments to address diverse patient needs— the already launched oral semaglutide for diabetes and advanced obesity management through Semaglutide 2.4 mg injection and the soon-to-be-launched Semaglutide injection in 0.25, 0.5 & 1.0 mg strengths for type 2 diabetes.

While Semaglutide injection (Ozempic) is new, Semaglutide tablet, marketed by Novo Nordisk under the brand name Rybelsus, was first approved for use as a diabetic drug in 2020 in India. In 2022, Novo Nordisk got CDSCO approval to market Semaglutide as an obesity drug under the brand ‘Wegovy” in both tablet and injectable forms. In February 2025, the company got approval to market Wegovy for additional indications like reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. While the company has been selling its Semaglutide tablets under Rybelsus and Wegovy brands for diabetes and obesity indications, respectively, in India, it launched the injectable Wegovy only in June 2025.

With the CDSCO approval for Ozempic, the entire Semaglutide range is going to be available in India soon.

However, that’s only half the story. The main patent protection Semaglutide has in India, as well as in several other key global markets, is about to expire few months from now.

The exciting opportunity the patent expiry offers for India’s generic pharmaceutical companies was highlighted as early as August 2023 in a study published by the Central government’s Department of Pharmaceuticals under the title “An Analysis on leveraging the patent cliff with drug sales worth $ 251 billion going off-patent”. The list of potential beneficiaries of the patent expiry of ‘Semaglutide’ in early 2026, highlighted in the report, included companies like Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Zydus, etc.  

For several months now, Indian generic companies have been actively seeking approvals for phase III clinical trials, bio-equivalence studies, etc, from CDSCO to be ready with market approvals to launch low-cost, generic versions of ‘Semaglutide’ as soon as Novo Nordisk’s patent rights on the medicine get over.  

The Subsequent New Drug Division of CDSCO, which deals with such medicines, has listed out the names of such generic players too. The companies that are trying to launch generic versions of Semaglutide in either injection or tablet or both forms include  Hetero Labs, Intas Pharmaceuticals, Cipla, Dr Reddy's, Biocon, Zydus, etc.

And generic companies are expecting good business not just from India but from other markets too. For instance, in an investor note in May, broking firm ICICI Direct points out that Dr Reddy’s management is targeting to launch Semaglutide not just in India, but also in Canada and Brazil in 2026.

An early launch of Ozempic, hence, is a necessity for Novo Nordisk as it has very little time left to get India’s diabetic patients onto Ozempic before generic floodgates open.