Amneal's Generic Valsartan & Hydrochlorothiazide Receives Approval in the U.S.
The price of top selling cardiac arrest drug sacubitril/valsartan sold by Swiss pharmaceutical company Novartis and its partners in India is expected fall as much as 60% with several Indian drugmakers gearing up to launch its generic version soon after the Delhi High Court cleared the decks for Indian generic makers by staying Novartis patents on the supra complex compound.
Dr Reddy's Laboratories on Wednesday said it has reduced the price of its cardiovascular drug Cidmus. The drug comprises combination of sacubitril and valsartan and is indicated for heart failure patients.
The Delhi High Court 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 top selling heart failure therapy Vymada, sold internationally as Entresto, till Thursday.
Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements.
Major companies including Natco, Cipla, Torrent, Lupin, Sun Pharma and USV are readying plans to enter the Rs 24,000-crore space to get a slice of the opportunity, with Swiss major Novartis's blockbuster cardiology drug losing patent protection in January.
The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.
Prinston's Generic Nebivolol HCL, Valsartan Receives Approval in the U.S.
As blockbuster heart failure drug Entresto inches toward a patent cliff, Novartis is calling on the FDA—again—to keep early-bird generics at bay.