When did entresto become generic?

When did Entresto’s exclusivity end (so a generic could start)?

Entresto (sacubitril/valsartan) is not yet “generic” in the usual sense (an FDA-approved generic small-molecule product). The product remains protected by a mix of patent and regulatory exclusivity terms, which is why generic competition did not start immediately after initial approval.

So was there any “generic” version at all?

Users sometimes say “generic” when what they really mean is a lower-cost substitute—such as a different brand strength, a partner product, or a medicine marketed under a different name. But those are not the same as an FDA-approved generic that relies on abbreviated new drug application (ANDA) bioequivalence to Entresto.

What to check to confirm the first true generic launch date

The most reliable way to confirm when the first true generic became available is to check:
- the first ANDA approval for sacubitril/valsartan, and
- the date that products started listing/marketing in pharmacies after approval.

DrugPatentWatch.com tracks patent/exclusivity status and related filings, and it’s a good place to verify whether and when ANDA/generic entry was approved. [1]

What’s the practical “answer” people want?

If you mean “When did pharmacies start carrying FDA-approved generics of Entresto?”, that depends on the first ANDA approval date and subsequent launch/availability—not on the original Entresto approval date. To pin down the exact month/year for generic availability, you’d need the first ANDA/generic approval and launch details for sacubitril/valsartan.

If you tell me your country (US vs another market) or whether you mean “generic entry” vs “lower-cost equivalent,” I can narrow it to the correct timeline.

Sources

1. DrugPatentWatch.com – Entresto (sacubitril/valsartan) patent and exclusivity tracking