Merck’s key diabetes drug goes off-patent, paves way for cheaper versions hit the market

INDIA – With Merk’s blockbuster drug, Januvia (Sitagliptin), a key anti-diabetic drug molecule set to go off-patent this month, the Indian pharmaceutical industry expects at least 200 new brands from 50 companies to enter the market in the next two months, Business Standard reports.

Diabetes patients stand to benefit from this as the drug’s prices are expected to crash 50-70 percent soon, say industry insiders.

Sitagliptin, developed by Merck & Co, is set to lose its patent, and a rush to launch copycat drugs is expected in the market.

Gliptin is the nickname for a relatively new group of medicines used to treat Type-2 diabetes. The oral anti-diabetes market in India is estimated at Rs 16,000 crore (about US$2 billion), and within it, gliptins are around Rs 3,500 crore (US$44.1 million) or so.

The launches have already begun. Mumbai-based Glenmark Pharma and Zydus LifeSciences have launched  generic versions of Sitagliptin and its combinations.

The current prices of Sitagliptin brands are in the range of Rs 38-42 (approximately US$0.5) a tablet.

Sheetal Sapale, president of market research firm AWACS, told Business Standard that Sitagliptin going off-patent this month was a key opportunity that players in the Indian pharma market would try to grab.

“There are 200 players now in the oral anti-diabetic market, of which the top 20 players contribute 80 per cent to the value and unit market,” she added.

Already a slew of generic drug makers, including Eris, Torrent Pharma, MSN, Intas, and Alkem, have entered this segment, launching generic versions at competitive prices.

Sapale estimated that more than 200 brands from 50 companies were expected to enter the Sitagliptin market by the end of August.

Her prediction stems from the fact that historically, the Indian pharma market has seen frenzied launches of copycat drugs in the anti-diabetes segment once patents expired.

For example, after Vildagliptin and the Vildagliptin-Metformin combination lost patent, the number of brands increased from 8 to 150 in just one year, and currently there are 209 brands in the domestic market.

Similarly, when Dapagliflozin and the Dapagliflozin-Metformin combination lost patent, the number of brands jumped from 9 (2020) to 80 (2021) in just one year, Sapale pointed out.

Glenmark the first to launch generic drug in India

The churn in the diabetes market started some years back when Teneligliptin lost its patent around 2015, and Glenmark was the first Indian firm to launch the drug at a 55 percent lower price.

 Following Glenmark’s generic entry, several other players stormed the market, leading to a price war. In December 2019, Novartis’ novel drug Vildagliptin lost its patent, following which a slew of generic brands entered the market, resulting in a sharp price drop of 70 percent within a month or so.

The next drug to go off-patent was Dapagliflozin in October 2020, which was innovated by British drugmaker AstraZeneca.

Gliflozins, or SGLT2 inhibitors, are another category of oral diabetic drugs. The originator AstraZeneca had sought the restraining of generic versions of its diabetes drug Dapagliflozin, but the plea was dismissed last year by the Delhi High Court.

AstraZeneca holds two patents for this drug in the country – one of which expired in October 2020 and another will expire in May 2023.

Already a slew of generic drug makers, including Eris, Torrent Pharma, MSN, Intas, and Alkem, have entered this segment, launching generic versions at competitive prices.

Sun Pharmaceuticals has a license to manufacture and commercialize dapagliflozin from AstraZeneca. The Sun Pharma brand in the market costs around Rs 30 (US$0.40) per tablet while the cheaper generic versions are in the range of Rs 11-15 (approximately US$0.20) per tablet.

Several drugs going off-patent in the anti-diabetes category have shaken up the market share dynamics. Sapale said the market share change indicated a shift towards gliptins and gliflozins, primarily pushed due to increased affordability.

From a 14 per cent share in 2018, the share of gliptins has risen to 20 percent of the anti-diabetes market in 2022, while the share of gliflozins has risen from 1 percent in 2018 to 5 percent now, Business Standard reports.

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