Prices of oral diabetes drugs set to fall as patents near expiry date

The diabetes segment has been growing faster than the country’s overall drug market


Diabetes drug | Patents | AstraZeneca

Sohini Das  | 

The Rs 15,000-crore diabetes drug market in the country is witnessing a churn with many patents reaching their expiry. For patients, that’s good news as far as medicine price is concerned. The diabetes segment has been growing faster than the country’s overall drug market.

A recent Delhi High Court order which dismissed an appeal by British drugmaker AstraZeneca that had sought restraining of the generic versions of its diabetic drug dapagliflozin, has now paved way for further price erosion in this segment.

AstraZeneca holds two patents for this drug in the country – one of which expired last October, and another will expire in May 2023. Already a slew of generic drug makers including Eris, Zydus Cadila, Torrent Pharma, MSN, Intas, Alkem have jumped into this segment launching generic versions at competitive prices. AstraZeneca had sought a restraining order against the marketing of the anti-diabetic drug by generic firms. AstraZeneca’s Dapagliflozin is sold under the brand Forxiga. It is a part of a popular class of anti-diabetic drugs called SGLT2 inhibitors, valued at around Rs 5,000 crore.

“Dapagliflozin prices will see further erosion. We have seen this happen with Vildagliptin and Teneligliptin earlier. The Delhi HC order is a welcome step in this direction, as multi-national firms have a tendency for evergreening their patents,” said a senior executive of an Ahmedabad-based firm.

Sun Pharmaceuticals has acquired the patent license to manufacture and commercialise dapagliflozin and dapagliflozin metformin combination in India from AstraZeneca which came into effect from May 28. Earlier Sun Pharma and AstraZeneca had a distribution agreement. The Sun Pharma brand in the market costs around Rs 30 per tablet, while the cheaper generic versions are in the range of Rs 11-15 per tablet.

The Delhi HC, however, has not found inventive merit over what was already existing in prior art (earlier patent), according to reports.

The churn in the diabetes market started some time back, and at least two key drugs in the gliptins category have gone off patent. In December 2019, Novartis’ novel drug vildagliptin lost its patent, following which over 20 generics have entered the market, resulting in more than 70 per cent price drop within a month or so. The price drop in vildagliptin shook the overall market dynamics in the gliptin space where teneligliptin was the enjoying a lion’s share of the prescriptions.

In January 2020, Rajeev Sibal, president, India Region Formulations, Lupin, one of the leading homegrown diabetes players had told Business Standard, that vildagliptin will eat into the share of a patented drug sitagliptin. “Vildagliptin is in a unique situation currently because of two reasons — when it comes to scientific documentation, it is very well documented (by large clinical trials) just like sitagliptin; and when it comes to price, it is as economical as teneligliptin now,” he said.

Sitagliptin is a Merck Sharp and Dohme drug that is likely to lose patent in July 2022. It is priced around Rs 15-20 per tablet compared to Rs 4-5 for vildagliptin post-patent expiry. 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.

Affordability was the key factor driving the success of teneligliptin so far, despite limited scientific data.

Apart from gliptins, the other category of diabetes drugs gliflozins have now started going off patent Generic drugs in this category will possibly shake up the oral diabetes medicine market in the country.

“So far, Indian players are selling gliflozins as tie-ups with multinationals. Almost every key player has started working on its generic gliflozin and would wait for the patents to expire. These are the latest global therapy and are now priced at around Rs 50 a tablet and prescribed only by specialists. This is the next category for a shake-up,” said the India sales head of a mid-sized Mumbai based pharma company.

Gliflozins have clocked a strong double digit growth since Johson & Johnson launched its canagliflozin in April 2015. This was followed by AstraZeneca’s dapagliflozin in June 2015 and Boehringer Ingelheim’s empagliflozin in November 2015. Since then, these companies have partnered with domestic majors to market their drugs. Recently Glenmark disrupted the market with its low-cost innovation remogliflozin. In December, Glenmark partnered with Mankind Pharma to market this drug.

Diabetes is a lucrative category for two reasons – one these are chronic medicines and the pandemic has shown that demand for such therapies hardly wanes, and secondly only 5 per cent of this market is covered under the National List of Essential Medicines or is under a price cap.

“Most of the time, MNCs are not in a position to employ such large field force required for covering the entire nation effectively; this will always be a major advantage for Indian players and will compel MNCs to partner with strong Indian players to ensure the reach required to make their products accessible to the vast Indian population,” said a senior executive at an Indian firm.

About 80 per cent of the diabetes therapy market is oral medicines, while insulin constitutes 20 per cent. According to the International Diabetes Federation (IDF), India recorded an estimated 77 million diabetes cases in 2019, of which only around 45 per cent were diagnosed. By 2030, this number could touch 100 million.

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