The potential of more affordable diabetic care comes in the wake of Swiss major Novartis-owned Vildagliptin losing patent on Monday — a development closely watched for months. Dozens of companies have readied plans to get a slice of the action in the growing Rs 14,000-crore diabetes therapy market, with the number of players expected to cross 50 soon.
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With the drug’s patent expiry, the price may drop to Rs 6 per tablet over the next few months, from the existing Rs 20-25 each. What makes the patent expiry significant for Indian pharma is that Vildagliptin is the first among the gliptins, a relatively new class of oral diabetes drugs, to get off the block, and also the first diabetes medicine whose end of patent life is being seen by industry. Vildagliptin is a part of a class of diabetes medications called dipeptidyl peptidase IV or DPP4 inhibitors.
The innovator brand Galvus (along with combination of Metformin) cornered around Rs 600 crore, a lion’s share of total Vildagliptin market of Rs 950 crore (moving annual total (MAT) November 2019). The company also has agreements with USV, Cipla and Abbott, with their brands Jalra, Vysov and Zomelis respectively available in 50mg Vildagliptin, and in combination with Metformin.
Days before the launch, the market started hotting up with Mumbai-based Eris Lifesciences acquiring Zomelis from Novartis for around Rs 100 crore, and USV reportedly being in talks to acquire Jalra. When contacted, a Novartis spokesperson said, “When patents expire, high-quality generics help lower the overall cost of healthcare and improve access to medicines for societies around the world, in a circle of discovery, development, commercialisation and loss of market exclusivity. We will continue to serve people living with diabetes through the innovator molecule in India, Galvus.”
Several players are expected to launch generic Vildagliptin including Zydus, Panacea Biotec, Emcure, Eris, Macleods, Aristo Pharma, Cipla, Micro Labs, USV, Intas, Mankind Pharma, as well as smaller regional players.
“This is a high-volume and high-growth market so there is room for good players. Pricing can vary, depending on the differential positioning and brand equity of the company”, Emcure Pharma executive director, Namita Thapar told TOI, adding it will enter the market this month. The company had ended its agreement three years back with Novartis.
“Price per tablet will come down hence market will shift to a more affordable treatment, which can then be prescribed to larger set of patients”, Rajesh Jain, MD Panacea Biotec, said.
Vildagliptin has a fourth of the over Rs 3600 crore gliptins’ market,, even as prescriptions are dominated by low-priced teneligliptin. Teneligliptin, disrupted the market with its affordability, and became the first molecule ever to reach the crucial milestone of touching 100-plus brands over a period of two years. A similar trend is expected in the case of Vildagliptin, considered a better and safer formulation, with several companies entering the fray. With the entry of over 25 players, price of the drug may settle around Rs 10 for a day’s therapy, drastically changing the landscape and bring in more patients in the advanced gliptin therapy, experts added.