As popular diabetes drug ‘vildagliptin’, marketed by Novartis here as ‘Galvus’, has gone off-patent in India, its price is expected to have dropped as much as 70 per cent with the introduction of cheaper copies.
While experts expect the development to improve patient access, some add the impact may not be as substantial as portrayed.
Vildagliptin, which belongs to a class of drugs called DPP-4, was first launched in the country in 2008 for the treatment of type-2 diabetes.
Today, vildagliptin, in combination with metformin, is the second-largest gliptin by market size after the sitagliptin-metformin combination. The drug is usually prescribed to be taken twice a day.
Once a drug’s patent expires, the firm with the patent loses its rights to exclusively market the formulation in the country, allowing other companies to enter the market with cheaper versions of the formulation known as ‘generics’.
Over 20 firms launched generic versions of vildagliptin and the vildagliptin-metformin combination on Tuesday, said industry analysts.
This includes firms like Zydus Cadila, expected to have launched Vinglyn (vildagliptin) and Vinglyn M (vildagliptin-metformin) and Eris Lifesciences, which had earlier this month announced the acquisition of the trademark for vildgliptin brand Zomelis from Novartis for a “head-start” over other generics. Panacea Biotec on Tuesday told the BSE that it had launched its generic brands ViLACT and ViLACT M.
India may see over 50 new brands launched in this space in the coming days, said Karishma Shah, founder and director of Pronto Consult.
Several companies have been scrambling for a piece of the vildagliptin market over the last few months, with the National Pharmaceutical Pricing Authority receiving applications from as many as 14 companies to fix the retail prices of their vildagliptin-metformin combinations in October. The prices for these combinations were set between Rs 6 and Rs 24 per tablet, depending on the strength of metformin and the company.
“The current price, which was around Rs 20-22 per tablet is set to see low prices as seen with Vinglyn at Rs 4.95 per tablet (for only vildagliptin) from Zydus and Vilglipt at Rs 6.50 per tablet from Vitabolik Pharmaceuticals,” said Hari Natarajan, founder and MD, Pronto Consult.
At the same time, doctors expect the price drop to have a marginal impact on improving access. “This drug will be more accessible to the middle class and lower-middle class population but, even when the patent was there, there were enough cheaper alternatives … I expect the number of patients benefitting from this to be miniscule because the price is not dropping to an insignificant value,” said Shashank Joshi, senior consultant-endocrinology, Lilavati Hospital.
“Drugs like sitagliptin, linagliptin, alogliptin and saxagliptin have documented cardiac safety trials, which vildagliptin does not have. Because of the cost of vildagliptin coming down, there may be a pressure on all evidence-based gliptins (to reduce its price),” he added.
“Gliptins are an important class of medication, but all of them are equally effective and there have always been cheaper gliptins like teneligliptin already available in the market. Bringing the cost down will not make much difference, at least to my practice,” said Richa Chaturvedi, senior consultant-endocrinology at Indraprastha Apollo Hospital.
“Most people with diabetes require several medicines apart from antidiabetic medicines, like blood pressure or cholestrol lowering medicines and certain vitamins. If the cost is not substantially low, there is no point prescribing this drug because it hasn’t proven itself to be substantially safer than the other gliptins,” she added.
The vildagliptin and vildagliptin-metformin market, valued at over Rs 900 crore in November 2019, accounts for roughly a fourth of the over Rs 3,500-crore gliptins market, as per data from AIOCD Awacs PharmaTrac.
“We will continue to serve people living with diabetes through the innovator molecule in India, Galvus. We will not be able to share our strategy as that is confidential information,” said a Novartis spokesperson.