Novartis recorded both a win and a loss last week in patent fights over its blockbuster heart drug Entresto.
Basel, July 07, 2023 — Novartis today announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. Novartis strongly believes the combination patent is valid and will appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) to reverse the District Court’s decision.
Basel, 31 March, 2023 — Novartis announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Entresto (sacubitril/valsartan) for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in pediatric patients aged from 1 to <18 years.
Sacubitril Valsartan`s USDMF has been submitted to USDMF
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.
JB Pharma on Monday announced a 50% price cut for its heart failure drug Azmarda, which is a sacubitril-valsartan combination, in anticipation of stiff competition with the drug going off-patent in January 2023.
Novartis files another Entresto patent suit to fight generics
Novartis is already suing a long list of generics producers that aim to bring copycats of the company's popular heart failure drug Entresto to market. Now, the Swiss pharma itself has become target in a patent infringement lawsuit.
Novartis income edges higher on strong Sandoz, Entresto
Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.