Novartis Expiry of Patent for Blockbuster Vildagliptin to Clear Way for Competitors

New Delhi: The patent protection of blockbuster anti-diabetic drug Vildagliptin manufactured by the Swiss drugmaker, Novartis, will soon expire on December 9, 2019. The expiry is likely to clear the way for other pharma firms eager to unveil the drug and its generic equivalent.

The competition for the launch of the drug has been fierce, however, Novartis had left no stones unturned to protect its formulation from being infringed. 18 pharma firms alone in the state of Gujarat were halted last year from launching the drug prior to the copyright expiry. Novartis had reportedly sought legal intervention to protect its drug against companies that even planned to launch the drug.

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However, after a span of five months, patented Vildagliptin will become vulnerable and a dozen of companies are reportedly preparing to grab a piece of the action in the increasing Rs 13000 crore diabetes therapy by launching the generic equivalent of Vildagliptin. As per the industry lookouts, companies including Zydus Cadila, Glenmark, Mankind Pharma, US Vitamins, Cipla and Abbott are keen to unveil the drug, reports TOI.

Vildagliptin is the first (diabetes) medicine whose end-of-patent life will be witnessed by an industry. It has about 25% share of the gliptins market of Rs 3500 crore. Gliptins, a relatively new class of oral diabetes drug, has emerged as a popular therapy and are contemplated to be the future of treatment.

The introduction of a generic version of the drug will reportedly cut the cost of the therapy by more than 50%, making it affordable for millions of diabetics. The price of the drug may settle around just Rs 10 for a days therapy which is currently priced as Rs 45. More patients will be drawn in advanced Gliptin therapy as the cheaper version will hit the market.

Commenting on the expiry of the drug, a Novartis spokesperson told TOI, "We believe the re-continues to be a huge unmet need in this segment. We are unable to share our plans post-patent expiry, as this is competitive information."

Talking to the daily, Mankind Pharma director Arjun Juneja said, "We have a strategic plan to enter this market. Our current diabetes and metabolic portfolio comprise of all major oral antihyperglycemic agents (OHAs) including Teneligliptin. However it is important to have a molecule in our portfolio which is highly potent, has strong scientific evidence-based efficacy and safety data."