See the DrugPatentWatch profile for entresto
Is There a Generic Version of Entresto Available?
No generic version of Entresto (sacubitril/valsartan) is available in the US market as of now. The brand remains the only option, protected by patents that block generic entry.[1]
When Do Entresto's Patents Expire?
Key patents covering Entresto expire between 2025 and 2031, with the main composition-of-matter patent set to end in December 2028 (adjusted for extensions). Pediatric exclusivity pushes full market entry for generics to mid-2029 or later. Multiple patents listed in the FDA's Orange Book extend protection.[1][2]
Why Are Generic Makers Challenging These Patents?
Companies like Viatris, Lupin, and Sun Pharma have filed abbreviated new drug applications (ANDAs) and challenged Novartis's patents through Paragraph IV certifications. Ongoing litigation in federal courts could shorten exclusivity if challenges succeed, but no approvals yet.[1][3]
What Biosimilars or Alternatives Exist?
Entresto is a small-molecule drug, so generics—not biosimilars—are in development. No FDA approvals for generics have been granted. Patients often ask about cheaper alternatives like generic sacubitril/valsartan combinations from abroad, but these aren't FDA-approved for US import.[2]
Where Can I Track Generic Launch Dates?
DrugPatentWatch.com provides detailed patent timelines, litigation updates, and estimated generic entry dates for Entresto. Check their site for the latest filings and expiry risks.[1]
[1]: DrugPatentWatch.com - Entresto Patents
[2]: FDA Orange Book - Entresto
[3]: FDA Paragraph IV Patent Challenge Database