Breather for Natco in Novartis cardiac drug case from Delhi High Court

In a breather to Indian drug makers, the Delhi High Court has advised the assistant patent controller to hear Hyderabad-based drugmaker Natco Pharma’s opposition to Novartis’ patent for the latter’s blockbuster heart failure drug (a combination of sacubitril and valsartan).

This decision by the court assumes significance because it would likely open the door for Indian pharma players to launch their generic versions of the heart failure drug Vymada (sold globally as Entresto).

The court had on Wednesday reserved the order on Natco Pharma’s writ petition over the grant of a patent to Novartis by the Indian Patent Office (IPO) for its drug Vymada.

Natco had argued before Justice C Hari Shankar (of the Delhi High Court) against the grant of the patent by the IPO to the pharmaceutical composition comprising sacubitril and valsartan as a sodium salt complex of the Vymada.

Had the court upheld Novartis’ latest patent, it could have potentially scuttled the plans of several Indian drug companies to launch their generic versions of this popular cardiac drug.

The patents of the Entresto fixed-dose combination are set to expire on January 16.

Industry sources say now with this order in favour of Natco Pharma, Indian companies may start launching generic versions as early as next week.

Vymada is a fixed-dose combination drug advised to heart-failure patients.

Sacubitril (neprilysin inhibitors) works to control blood volume while valsartan is a common anti-hypertensive. This effect reduces work on the heart and reduces blood pressure. The combined effect of the two medicines reduces the strain of the failing heart.

Several Indian drug firms are in the fray to launch the generic of this heart failure medicine, which has already managed to reach a size of Rs 550 crore in the Indian cardiac market.

Globally, this drug is estimated to have a size of $4 billion.

“The top firms are readying to launch the drug, and price slashes would be in the range of 50-70 per cent immediately,” said an industry source. At present, each Vymada 100mg tablet costs around Rs 85.

Dr Reddy’s Laboratories has armed its arsenal by acquiring the Cidmus brand from Novartis earlier this year for Rs 463 crore.

Trade sources say this is one of the fastest-growing drugs in the Rs 23,000 crore cardiac market in the country.