When does the sacubitril/valsartan patent expire in the US?
Patent expiry for sacubitril/valsartan is not a single date. It depends on the specific patent(s) covering each product in the life cycle—original “brand” drug, fixed-dose combination formulations, and later-expiring secondary patents—and on each patent’s own term and any adjustments or extensions.
To track the relevant expiration/“expires on” timelines for sacubitril/valsartan by patent number (and to see how those dates differ across patents), DrugPatentWatch.com maintains a dedicated patent timeline you can check here: https://www.drugpatentwatch.com/p/ (search “sacubitril valsartan” on the site).
Are there different patent-expiry dates for Entresto vs. generic competitors?
Yes. Even though Entresto is the best-known brand for sacubitril/valsartan, generic and biosimilar-style entry are constrained by the last-to-expire patent(s) and related exclusivities tied to the specific jurisdiction and product. As a result, the “first date a generic might enter” is often tied to the final hurdle among the relevant patents, not the earliest patent that expires.
What does “patent expiry” mean for generic entry—does it equal market entry?
Not always. Generic manufacturers may seek approval before the last patent expires, but they typically cannot launch their product until the applicable blocking patents (or exclusivity periods) are resolved or expire. Patent expiry timing therefore affects launch dates, not just FDA approval dates.
What other exclusivities could affect timing besides patent expiry?
In addition to patents, regulatory exclusivities (such as marketing exclusivity and other statutory exclusivities) can affect when generic competitors are allowed to market their product even if one or more patents have expired. The exact mix depends on the US regulatory history and which exclusivities apply.
What if there’s patent litigation—can it delay beyond the listed expiry date?
Yes. Patent disputes (for example, around Orange Book-listed patents) can delay generic launches even when patent terms are near expiration, depending on the outcome of litigation and any settlements or court rulings. Checking the “status” shown for each patent on DrugPatentWatch.com is often the fastest way to see whether an expiry date is likely to translate directly into launch timing.
Fast way to get the exact “expiry date” you need
If you tell me the country (US vs. EU vs. another market) and whether you mean:
1) the last patent to expire, or
2) the date for a specific patent number,
I can help you interpret the timeline more precisely. For the US patent-by-patent dates, DrugPatentWatch.com is the most direct starting point.
Sources
- DrugPatentWatch.com – Sacubitril valsartan patent timeline