FDA Orange Book · active-ingredient family
Sacubitril; valsartan
Sacubitril; valsartan: 2 brands, 15 generics; first approved Jul 07, 2015; generic available.
Generic available
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
15
Listed patents
9
Next patent expiry
Nov 08, 2026
in 2 mo
Brand (NDA) products
Originator applications
- NOVARTISNDA 21859120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG;6MG CAPSULE, PELLETS ORAL Rx — 15MG;16MG CAPSULE, PELLETS ORAL Rx — - ENTRESTORLDNOVARTIS PHARMS CORPNDA 20762020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB
Generic (ANDA) products (15)
Abbreviated applications
- UMEDICAANDA 21994620263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - SOMERSET THERAPS LLCANDA 21998320263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - HETERO LABS LTD IIIANDA 21366820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - MSNANDA 21374820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - NOVUGEN PHARMA SDNANDA 21361120253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - DR REDDYSANDA 21362720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - LUPINANDA 21380820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - MACLEODS PHARMSANDA 21372820243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - ALKEM LABS LTDANDA 21376420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - BIOCON PHARMAANDA 21368020243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - TORRENTANDA 21360420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - ZYDUS PHARMSANDA 21371920243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - ALEMBICANDA 21368220243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - CRYSTALANDA 21360520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB - LAURUSANDA 21367620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG;26MG TABLET ORAL Rx AB 49MG;51MG TABLET ORAL Rx AB 97MG;103MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9388134 | in 2 mo | U-1723 | |
| 9388134*PED | in 8 mo | ||
| 8877938 | in 8 mo | SubstanceProduct | |
| 8877938*PED | in 1 yr 3 mo | ||
| 11135192 | in 7 yr | U-3084 | |
| 9517226 | in 7 yr | U-3084 | |
| 9937143 | in 7 yr | U-3084 | |
| 11058667 | in 9 yr 9 mo | U-3170 | |
| 10722471 | in 10 yr 6 mo | ProductU-3896 |
Approval history
FDA approval span
First approval
11 yr 4 mo ago
Most recent approval
1 mo ago
Approvals span 2015–2026 across 17 FDA applications.
Brand (NDA) 212%
Generic (ANDA) 1588%
Sacubitril; valsartan: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
