Novartis fails to stop generic heart drug approval in US court
Novartis lost its attempt to prevent FDA approval of a generic version of its heart failure drug Entresto The court ruled that the FDA didnt exceed its authority in approving MSN Pharmaceuticals generic despite label differences
Novartis‚ a Swiss pharmaceutical giant‚ recently faced a setback in its efforts to maintain market exclusivity for its top-selling heart failure medication‚ Entresto. The companys bid to block the U.S. Food and Drug Administration (FDA) from approving a generic version was unsuccessful
U.S. District Judge Dabney Friedrich made public an order last tuesday that upheld the FDAs decision to approve MSN Pharmaceuticals generic version of Entresto. The ruling stated that the FDA didnt overstep its bounds‚ despite Novartis arguments about label differences and alleged disparities between the drugs
Entresto which earned Novartis more than $6 billion in revenue last year‚ stands as the companys best-selling product. The FDA green-lit MSNʼs generic version about a month ago‚ marking it as the first U.S. generic of the drug
However‚ the path to market for MSNʼs generic isnt clear-cut. Novartis has initiated separate legal proceedings against MSN for patent infringement. While Novartis lost a bid to block MSNʼs generic in that case around two months ago‚ MSN is still barred from launching its product as Novartis appeals the order
The legal battle between Novartis and the FDA began roughly three months ago when Novartis filed a lawsuit shortly after the agency approved MSNʼs application. The company claimed the approval was arbitrary capricious and violated the federal Food Drug‚ and Cosmetic Act (FDCA) in multiple ways
Novartis main argument centered on label differences. Entresto‚ initially approved about nine years ago‚ later expanded its indications based on additional clinical trials. MSNʼs generic label omitted certain indications to avoid patent infringement‚ a practice known as “skinny labels“
The federal Food Drug‚ and Cosmetic Act prevented MSN from “reverting“ to an older label that had been suspended and replaced
Judge Friedrich rejected Novartis arguments‚ citing longstanding precedents and FDA guidelines. The judge also dismissed Novartis claims about differences in drug composition‚ stating that the FDAs scientific judgment deserves deference
Novartis has expressed disagreement with the ruling and plans to appeal the decision. The ongoing legal battles highlight the complex interplay between patent protection‚ generic competition‚ and regulatory decisions in the pharmaceutical industry
