Pricing regulator closely watching prices of diabetes drug going off patent

With more patients shifting to new gliptins (a category of diabetes drugs) as they go off-patent, the national pharma pricing regulator has moved quickly to cap prices of two diabetes molecules Sitagliptin and Linagliptin and their combinations.

Around nine per cent of India’s 1.4 billion population has Type-2 diabetes, and this has crossed 11 per cent in few urban pockets. It is thus estimated that 100 million people in India have diabetes, but about half the Type-2 diabetes cases go undiagnosed.

Government sources reveal that the regulator is keeping a keen watch on diabetes drug prices, and also on the new category of drugs (gliptins and gliflozins) that are now going off-patent. “As generic brands enter the market, the competition is bringing the prices down. Thus patients, who could not afford these drugs earlier, are shifting. Therefore, it’s necessary to keep a tab on the prices,” said the official.

The National Pharmaceutical Pricing Authority (NPPA) has capped the prices of these two drugs in the range of Rs 16-25 per tablet. While Sitagliptin and its combinations (with metformin etc) have been capped between Rs 16-21 per tablet, for linagliptin and its molecules it has been capped at Rs 16-25 per tablet. Linagliptin, a Boehringer Ingelheim drug, is set to go off-patent next year.

Sheetal Sapale, president-marketing, AWACS, a research and analytics firm explained that 5 per cent of Sitagliptin (plain doses) is captured already by generic brands within a month of this molecule going off patent. Around 27 players with 85 generic brands have already flooded the market, and over the next few months around 50 players with 100 sitagliptin and its combination brands are expected to hit the Indian market.

She says that prices have already crashed-–while the innovator price of Sitagliptin is Rs 36-45 per tablet, the generic brands are priced in the range of Rs 7-15. “The generic brands are one-third of the innovator prices. And there is also a large price range among generic brands-–the lowest priced one is half that of the highest priced generic brand,” she adds.

While many patients who can afford it may prefer to stay with the innovator brand, this patent expiry may also generate fresh prescriptions. People who are now on basic treatment using an old class of sulphonylurea drugs, and who have not opted for gliptins due to affordability concerns, may now shift to gliptins. Already drugs in this space, such as vildagliptin, teneligliptin have gone off patent.

Sitagliptin (plain) has clocked a 54 per cent jump in volumes in July over June, according to AWACS data, while there has been a value growth of 14 per cent.

The overall anti-diabetes market has declined by one per cent during the past 12 months (up to July), but in July alone, there has been a value growth of 12.7 percent owing to this one drug going off patent.

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

Overall	Sitagliptin	Sitagliptin +Metformin combination
Players	27	27	27
Brands	85	34	36
MSD (MRP/tablet)	Rs 36-45	Rs 20-23
Others	Rs 9-21	Rs 12-21

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