Price of key diabetes drug may crash as Novartis risks losing patent

Topics Novartis

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Come December when India’s 72-million diabetics would cheer a price crash of popular medicine Vildagliptin, drug’s patent holder Novartis would have an uphill task at hand. Reason —  market sources claim the price of the therapy can come down by as much as 75 per cent as players rush to launch their generic versions with the Swiss multinational firm set to lose its patent. 

Novartis has been fighting tooth and nail to stop domestic drug makers from launching its variants of Vildagliptin taking advantage of a first patent expiry in 2017. The secondary patent covering it ends in December. The domestic pharma market is thus abuzz as a key gliptin (nickname for a relatively new group of medicines used to treat Type-2 diabetes), which accounts for nearly 25-30 per cent of the Rs 3,500-crore gliptin market, is set to go off patent. 

Novartis has filed injunctions against several companies in the past few years (industry sources claim over 70 injunctions) to stop them from launching their generic versions of Vildagliptin, which it sells under the brands Galvus and Galvus Met. Galvus Met has clocked a 22.3 per cent value compound annual growth rate (CAGR) in the past five years, the data from market research firm AIOCD AWACS showed. It is not only one of brands of Novartis, but also one of the fastest growing. 

Meanwhile, industry sources claim several Indian companies are ready with their versions of gliptins and would launch in December. At present, the cost of a single dose of Vildagliptin is Rs 20-22, and usually a patient takes two doses per day. 

“The price of the drug can come down to as much as Rs 5 per dose by smaller firms. Such patent expiries are huge opportunities for smaller firms to grow. At least 50 companies (mid-sized and big ones) are ready with their Vildgliptin product and bulk drug supply,” said the national head of the cardio-diabetic division of a mid-sized drug firm. 

His firm is ready with their Vildagliptin with branding and marketing strategies in place. 

A look at the top 10 brands of Novartis in India shows that mature brands like Voveran and Calcium Sandoz are clocking low single-digit growth — 3.6 per cent and 0.6 per cent, respectively. The top 10 brands have multiple vitamin and mineral brands, which are stable, but now face competition from home-grown players. 

Novartis has tie-ups in place with Cipla, USV Pharma, Emcure, and Abbott for vildagliptin. Sources indicate that most of these companies have their own versions of the drug ready. 

“Novartis would be forced to cut prices, but it is unlikely to bring it down to half or so. It would continue to benefit from having a well-entrenched brand in the Indian market, Galvus Met and patients in the chronic category seldom switch to other brands,” said an analyst who tracks multinational drug firms. 

India has over 72 million people suffering from diabetes. We believe that there continues to be a huge unmet need in this segment. We at Novartis will continue our commitment to patients living with diabetes. Our patent for vildagliptin comes to an end in December this year. We are unable to share our plans post expiry of the patent as this is competitive information," said a Novartis spokesperson. 

Gliptins as a category are clocking a 35-40 per cent growth rate, compared to the diabetes segment, which is growing at 12-14 per cent. At least four key gliptins (Sitagliptin, Linagliptin, Vildagliptin, and Saxagliptin) are expected to go off-patent within the next five years.

Earlier, once Mitsubishi Pharma's patent for teneligliptin was over, several domestic players rushed to launch the drug. This had led to a price war. 

Glenmark was the first to launch its generic version in June 2015 at Rs 19.90 per tablet per day treatment. It brought down prices after Mankind Pharma and Zydus Cadila launched teneligliptin priced at Rs 7 per dose. In the next two years, over 100 teneligliptin brands were launched.

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