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Last Updated : Dec 17, 2019 09:07 PM IST | Source: Moneycontrol.com

Vildagliptin's patent expiry to make way for new SGLT2-based drugs for type-2 diabetes treatment

The market for SGLT2 inhibitors stood around Rs 996 crore, as moving annual total (MAT) on November 2019, growing little above 20 percent.

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The Rs 15,000 crore Indian anti-diabetes drug market is in for a shake-up as companies shift their focus towards promoting the latest generation of SGLT2 inhibitor molecules, which are expensive and protected by patents.

The loss of patent exclusivity by Novartis' Vildagliptin is expected to hasten the transition.

There are four versions of SGLT2 (sodium glucose co-transporter-2) inhibitors or gliflozins sold in India.

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They are: dapagliflozin (Farxiga), made by British drug maker Astrazeneca, US-based Johnson & Johnson’s canagliflozin (Invokana), Germany-based Boehringer Ingelheim's empagliflozin (Jardiance) and Glenmark’s remogliflozin etabonate (Remo).

The cost of the first three molecules range anywhere between Rs 450 to Rs 550 for 10 tablets. Glenmark’s Remo is priced the lowest at Rs 125 for 10 tablets. The tablets are meant to be taken twice daily.

Around half a dozen drug companies market these four molecules in India under co-marketing licenses from these four companies. Sun Pharma and Abbott sell dapagliflozin, USV and Cipla sell canagliflozin, Lupin sell empagliflozin and Torrent Pharma  sell remogliflozin. However the innovator companies will tightly control the pricing and marketing of these drugs.

USV, Abbott and Cipla are marketing vildagliptin.

The move from gliptins to gliflozins 

The market for SGLT2 inhibitors stood around Rs 996 crore, as moving annual total (MAT) on November 2019, growing little above 20 percent, according to AIOCD. The market for gliptins (DPP-4 inhibitors) in India, is around Rs 3,510 crore. Apart from Vildagliptin, there are other gliptins like Sitagliptin, Saxagliptin and Teneligliptin.

"This is an innovator-patented category. It is really picking up well. The companies will definitely promote SGLT2 (inhibitor brands) aggressively compared to gliptins," said Hari Natarajan, Founder and Managing Director of Pronto Consult, specialising in doctor perception studies and market insights in India and Middle East.

"With Glenmark also jumping into the fray, we expect there to be significant traction of SGLT2 inhibitor molecules going forward," Natarajan said.

Another executive at a large India drug maker who deals with diabetes initiatives said while gliptins continue to rule,  the market for SGLT-2 inhibitors is  expanding.

"If you look at the global developments all the (clinical trial) evidences  - show SGLT2 inhibitors good in terms of cardiovascular benefit and renal protection and all that. None of the gliptins have shown cardiovascular benefit, and the market for gliptins is not growing globally," the executive said.

The clinical studies of Dapagliflozin (Astrazeneca's Farxiga) showed a reduced risk of mortality and heart failure (HF) events, improved symptoms in patients with heart failure both with and without type-2 diabetes, according to latest clinical results presented at the American Heart Association 2019 Scientific Sessions.

"The cardiologists are writing SGLT2 inhibitors, more actively," the above executive said.

Sources told Moneycontrol that SGLT2 inhibitors are now prescribed after trying metformin or with metformin as first line in treating type-2 diabetes.

Metformin is usually prescribed as first line of treatment along with excercise and diet for people with type-2 diabetes.

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First Published on Dec 17, 2019 09:05 pm
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