Glenmark pharma launches generic version of Novartis' heart failure drug

Opens floodgates for more generic launches; 40 new brands expected

India’s Rs 20,000-crore cardiac drug market is in for a shake-up as generic launches of Novartis’ heart-failure drug Vymada begin. Mumbai-based Glenmark Pharmaceuticals on Monday announced the launch of their own brand of Sacubitril-valsartan tablets Sacu V, priced between Rs 19-35 per tablet.

Sheetal Sapale, president (marketing), AIOCD-AWACS said that at least 40 more brands are expected to be launched in this category, leading to a price erosion of at least 50 per cent.

Earlier in December, JB Pharma, which had acquired the Azmarda brand from Novartis AG, Switzerland for the India region for a consideration of Rs 246 crores in April 2022, had slashed its prices by half to Rs 39.6 per tablet. Only four companies were marketing Novartis’ drug in India who had acquired the brands from the innovator – Mankind, Dr Reddy’s Laboratories, JB Pharma apart from Novartis itself. Now, a slew of generic makers is set to enter.

According to IQVIA sales data, as of December 2022 moving annual turnover (MAT), the total cardiology market is estimated to be Rs 20,730 crore, growing at 7.7 per cent. The market for sacubitril-valsartan combination is estimated to be Rs 514 crore, with an annual growth of 37.2 per cent.

The patents of the Entresto fixed-dose combination of sacubitril-valsartan expired on January 16. 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 heart failure drug (a combination of sacubitril and valsartan).

This decision by the court opens the door for Indian pharma players to launch their generic versions of the heart failure drug Vymada (sold globally as Entresto). 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.

Alok Malik, executive vice-president and business head, India Formulations, Glenmark Pharma said, “Heart failure is growing in India at an alarming rate; its prevalence is about 1 per cent and affects around 8-10 million individuals.” Sacu V will be an affordable treatment option for patients for a drug that has shown to reduce the risk of cardiovascular death or heart failure hospitalisation and to improve symptoms associated with heart failure.

The sacubitril-valsartan combination is currently prescribed to 30-35 per cent of heart failure patients, and doctors believe that this share can go up to 50-60 per cent with the right pricing.

Meanwhile, India’s price regulator is keeping a close watch on key drugs going off-patent. The Centre and the industry are working on a pricing mechanism for drugs that are going off-patent.

“While a final decision is yet to be made, the pricing mechanism is likely to set a ceiling price for drugs going off patent at 50 percent of the innovator price. Add to this, if there is any other drug which is already under price control in combination with the patented molecule, then one may take a ceiling price which is 20 per cent lower than the prevailing ceiling price,” an industry source explained.