FDA Orange Book · active-ingredient family
Sacubitril; valsartan
Sacubitril; valsartan is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ENTRESTO SPRINKLE · NDA 218591
2
Brand (NDA)
14
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, pellets, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENTRESTO SPRINKLERLD×2 | NOVARTIS | NDA 218591 | — | Apr 12, 2024 | |
| ENTRESTORLD×3 | NOVARTIS PHARMS CORP | NDA 207620 | AB | Jul 07, 2015 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SACUBITRIL AND VALSARTAN×3 | SOMERSET THERAPS LLC | ANDA 219983 | AB | Jan 20, 2026 | |
| SACUBITRIL AND VALSARTAN×3 | HETERO LABS LTD III | ANDA 213668 | AB | Jul 17, 2025 | |
| SACUBITRIL AND VALSARTAN×3 | MSN | ANDA 213748 | AB | Jul 16, 2025 | |
| SACUBITRIL AND VALSARTAN×3 | NOVUGEN PHARMA SDN | ANDA 213611 | AB | Jul 16, 2025 | |
| SACUBITRIL AND VALSARTAN×3 | DR REDDYS | ANDA 213627 | AB | Jan 13, 2025 | |
| SACUBITRIL AND VALSARTAN×3 | LUPIN | ANDA 213808 | AB | Jan 08, 2025 | |
| SACUBITRIL AND VALSARTAN×3 | MACLEODS PHARMS LTD | ANDA 213728 | AB | Oct 16, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | ALKEM LABS LTD | ANDA 213764 | AB | Sep 16, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | BIOCON PHARMA | ANDA 213680 | AB | Aug 30, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | TORRENT | ANDA 213604 | AB | Aug 22, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | ZYDUS PHARMS | ANDA 213719 | AB | Jul 09, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | ALEMBIC | ANDA 213682 | AB | May 28, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | CRYSTAL | ANDA 213605 | AB | May 28, 2024 | |
| SACUBITRIL AND VALSARTAN×3 | LAURUS | ANDA 213676 | AB | May 28, 2024 |
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9388134 | Nov 08, 2026 | in 5 mo | U-1723 |
| 9388134*PED | May 08, 2027 | in 11 mo | |
| 8877938 | May 27, 2027 | in 11 mo | SubstanceProduct |
| 8877938*PED | Nov 27, 2027 | in 1 yr 6 mo | |
| 11135192 | Aug 22, 2033 | in 7 yr 3 mo | U-3084 |
| 9517226 | Aug 22, 2033 | in 7 yr 3 mo | U-3084 |
| 9937143 | Aug 22, 2033 | in 7 yr 3 mo | U-3084 |
| 11058667 | May 09, 2036 | in 10 yr | U-3170 |
| 10722471 | Feb 02, 2037 | in 10 yr 9 mo | ProductU-3896 |
Sacubitril; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
