Is There a Generic for Entresto?
No, there is no FDA-approved generic version of Entresto (sacubitril/valsartan) available in the US as of now. Entresto, made by Novartis, treats heart failure with reduced ejection fraction. Its main patents block generic entry until at least 2025-2031, depending on specific claims.[1]
When Can Generics Enter the Market?
Novartis holds multiple patents on Entresto listed in the FDA's Orange Book. Key ones expire between 2025 and 2031, with pediatric exclusivity potentially extending some to 2032. No generics have been approved yet, but companies like Alembic, Lupin, and Mylan have filed abbreviated new drug applications (ANDAs) challenging these patents, triggering Paragraph IV litigation. First generic approvals could come after court rulings or settlements, likely not before late 2025.[1][2]
Link to detailed patent info: DrugPatentWatch.com/Entresto
What Patent Challenges Are Underway?
Several generic makers have challenged Novartis's patents via ANDA filings. For example:
- Lupin filed in 2021, facing suits over formulation and method-of-use patents.
- Viatris (Mylan) and others followed, with cases in federal court.
Settlements could delay generics, as seen in past Novartis cases. Track status on FDA's Orange Book or court dockets for updates.[1][3]
How Much Does Entresto Cost Without Generics?
Brand-name Entresto lists at about $600-700 for a 30-day supply (90/90mg tablets), though copay cards and patient assistance lower it for many. Generics would likely cut prices 80-90%, based on similar heart drugs like generic sacubitril/valsartan combos overseas.[4]
What Are the Alternatives Right Now?
No direct generic, but options include:
- Other heart failure drugs like carvedilol (Coreg generic), lisinopril, or spironolactone—often cheaper but less targeted for HFrEF.
- Valsartan alone (generic since 2012) for blood pressure, though it lacks Entresto's sacubitril component for neprilysin inhibition.
Doctors weigh these based on ejection fraction and symptoms; Entresto outperforms ACE inhibitors in trials like PARADIGM-HF.[5]
Sources:
[1]: DrugPatentWatch.com/Entresto
[2]: FDA Orange Book
[3]: USPTO Patent Database
[4]: GoodRx Entresto Pricing
[5]: NEJM PARADIGM-HF Study