The Indian Patent Office’s decision to revoke Novartis’ patent on its blockbuster cardiac drug, Vymada, is set to reshape the country’s ₹550-crore market for the therapy. The move opens the floodgates for generic competition, likely slashing prices by over 70 per cent and significantly improving access for India’s vast cardiovascular patient base.
Vymada, considered among the most important cardiology drugs globally, commands 2.4 per cent of India’s ₹23,000-crore cardiac drug segment. The therapy has seen a robust 37 per cent annual growth rate, underscoring strong clinical adoption and rising demand.
“Vymada holds a significant presence in India, with sales of around ₹550 crore,” said Group CEO and Co-Founder, Primus Partners, Nilaya Varma.
“With the patent revoked, more than 15 leading Indian pharmaceutical companies are strategically positioned to launch generics within the next two to three months,” Varma added.
With the revocation, analysts expect the Indian market to see a wave of competition. Prices, currently hovering around ₹650–700 per strip, are set to fall sharply.
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The Patent Office, in its ruling, said Novartis’ patent lacked novelty and technical advancement, noting that the company had failed to show enhanced therapeutic efficacy or comparative benefits of its supramolecular complex over prior disclosures. The order invoked Section 3(d) of the Indian Patent Act, the same provision under which Novartis lost its cancer drug Glivec in 2013.
Over the years, generics from Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences were restrained by courts after Novartis’ legal action, even as some players launched “at risk.”
In a rare move, the Indian Pharmaceutical Alliance, along with IPCA and Micro Labs, opposed the patent at the post-grant stage, citing evergreening concerns.
The patent revocation of Vymada opens up a large cardiac market in India, where sacubitril-valsartan has already established itself as a high-value product. “With generics entering, we expect initial launches to price at a premium, but competition will drive a 50-70 per cent correction over the next 12-18 months. This will significantly expand patient access while normalising returns for manufacturers,” said Nirali Shah, Pharma Analyst at Ashika Group.
“Intense competition from generics will likely drive prices down by more than 60 per cent over the next year,” said Varma. “This significant correction will enhance accessibility for millions of patients struggling with cardiovascular disease and high treatment costs.”
While Novartis is expected to challenge the ruling, industry watchers believe the decision marks a decisive shift towards affordability in one of India’s fastest-growing therapeutic areas.
