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Novartis Keeps Faith That Six-Month Entresto Extension Will ‘Be Respected’

MSN’s ANDA Still Barred By Administrative Stay In US Topsy-Turvy Legal Battle

 
• By Dean Rudge

Reporting global Entresto sales of more than $7.8bn in 2024, Novartis spoke to investors on the latest legal dynamics for its best-selling product as the threat of US generic competition from MSN Laboratories continues to loom.

patent
• Source: Alamy

As MSN Laboratories continues to battle hard in court to accelerate the launch of its US generic version of Novartis’ Entresto (sacubitril/valsartan), the Swiss originator has told investors that “we currently believe we will be able to secure” a six-month pediatric extension for one of its key Entresto patents, maintaining expected loss-of-exclusivity for the heart failure mega-blockbuster in the middle of 2025.

With US Food and Drug Administration approval for its Entresto abbreviated new drug application product in hand, MSN Labs had last month pushed to launch its generic with the expiry...

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