sacubitril; valsartan · Novartis · NDA 218591
Entresto Sprinkle
Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Feb 2037
Blocked by patent: US 10722471.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10722471 | drug product, use U-3896 · sets the listed date | 2 Feb 2037 |
| US 8877938 | drug substance, drug product | 27 May 2027 |
| US 9388134 | use U-1723 | 8 Nov 2026 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218591 · 001 · RLD | capsule, pellets, oral | 6MG;6MG | 2 Feb 2037 |
| 218591 · 002 · RLD | capsule, pellets, oral | 15MG;16MG | 2 Feb 2037 |