Lupin's Generic Entresto Approved by USFDA, Set to Rival Novartis' Bestseller
Mumbai: In a fresh challenge to Novartis' blockbuster heart failure drug Entresto, Indian generics maker Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its generic version of Sacubitril and Valsartan Tablets. This comes amid an ongoing legal tussle between Novartis and generics manufacturers, including MSN Pharmaceuticals.
Announcing the approval, Lupin confirmed that its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets has been cleared by the FDA. These tablets are indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure and reduced ejection fraction, as well as for treating symptomatic heart failure in pediatric patients aged one year and older.
Also Read: Lupin receives USFDA approval for heart failure drug
Entresto remains one of Novartis' top-selling drugs, according to a recent media report in ET, generating over USD 6 billion in the U.S. drug market in 2023. However, the Swiss pharmaceutical giant has been aggressively defending its patent, leading to multiple lawsuits against generics manufacturers.
In 2022, Novartis sued MSN Pharmaceuticals and other companies in a Delaware federal court, alleging patent infringement over their generic versions of Entresto. It also took legal action against the FDA, arguing that the agency’s approval of MSN’s generic was “unlawful.”
Also Read: US Appeals Court decision favors MSN Pharma in Novartis heart drug Entresto generic dispute
Despite these efforts, Novartis faced setbacks. In August 2023, U.S. District Judge Richard Andrews denied the company’s request for a preliminary injunction, stating that Novartis was unlikely to succeed in its infringement claims. However, MSN’s generic launch was temporarily paused as Novartis pursued an appeal.
Most recently, a Washington, D.C. federal judge rejected Novartis’ last-minute attempt to block MSN’s generic launch, paving the way for the first U.S. generic version of Entresto.
With Lupin now securing FDA approval, Novartis is set to face yet another challenge to its multibillion-dollar heart failure drug in the generics market.
