The cardiac drug market in India, worth 200 billion rupees, is set to change as generic versions of Novartis’ heart failure medication Vymada are introduced. On Monday, Glenmark Pharmaceuticals, based in Mumbai, revealed the release of their Sacubitril-valsartan tablets, called Sacu V, with prices ranging from 19 to 35 rupees per tablet.

Sheetal Sapale, President of Marketing at AIOCD-AWACS, stated that around 40 additional brands are predicted to be introduced in this market segment, resulting in a decrease in prices by at least 50%.

In December, JB Pharma, a company that bought the rights to sell the Azmarda brand from Novartis AG in India for 246 crores rupees in April 2022, reduced its prices to 39.6 rupees per tablet. Only four companies were authorized to sell Novartis’ drugs in India, including JB Pharma, Mankind, Dr. Reddy’s Laboratories, and Novartis itself. However, now many generic manufacturers are planning to enter the market.

According to data from IQVIA, as of December 2022, the total cardiology market in India is estimated to be worth 20,730 crores rupees and is growing at a rate of 7.7%. The market for the sacubitril-valsartan combination drug is estimated to be worth 514 crores rupees and is growing at a rate of 37.2%.

The patents for the Entresto fixed-dose combination of sacubitril-valsartan expired on January 16th. The Delhi High Court has directed the Assistant Patent Controller to hear the opposition filed by Natco Pharma, an Indian drug manufacturer, against Novartis’ patent for their heart failure drug, which is a combination of sacubitril and valsartan.

This decision by the court allows Indian pharmaceutical companies to launch generic versions of the heart failure drug Vymada (marketed as Entresto globally). If the court had upheld Novartis’ patent, it would have likely prevented Indian drug companies from launching their generic versions of this widely used cardiac medication.

According to Alok Malik, the executive vice-president and business head of India Formulations at Glenmark Pharma, the rate of heart failure in India is rapidly increasing and affects about 8-10 million individuals, or 1% of the population. Glenmark’s new drug, Sacu V, will provide an affordable treatment option for these patients, as it has been shown to decrease the risk of death from heart failure or hospitalization for heart failure symptoms.”

Currently, 30-35% of heart failure patients have prescribed the sacubitril-valsartan combination, but doctors believe that this percentage could increase to 50-60% with appropriate pricing. 

The Indian government’s price regulator is closely monitoring drugs that are going off-patent, and the government and the pharmaceutical industry are developing a pricing system for these drugs.”