FDA Orange Book
Is there a generic for Entresto Sprinkle?
Entresto Sprinkle contains sacubitril and valsartan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Entresto Sprinkle (sacubitril and valsartan). The Orange Book shows its last listed patent expires February 2, 2037.
Run it in Rivvi
Map Entresto Sprinkle and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Entresto Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, pellets, oral | 15MG;16MG | Marketed (Rx) | None | 0 | None |
| capsule, pellets, oral | 6MG;6MG | Marketed (Rx) | None | 0 | None |
NDA 218591, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Entresto Sprinkle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9388134 | November 8, 2026 | Method of use | U-1723 | 218591 |
| 8877938 | May 27, 2027 | Drug substance, Drug product | None | 218591 |
| 10722471 | February 2, 2037 | Drug product | U-3896 | 218591 |
Entresto Sprinkle NDC codes
Questions
Is there a generic for Entresto Sprinkle?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Entresto Sprinkle (sacubitril and valsartan). The Orange Book shows its last listed patent expires February 2, 2037.
What is the generic name for Entresto Sprinkle?
The active ingredient in Entresto Sprinkle is sacubitril and valsartan, per the FDA Orange Book.
When does the Entresto Sprinkle patent expire?
The last patent listed for Entresto Sprinkle in the Orange Book expires February 2, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.