FDA Orange Book
Generic for Entresto
Entresto 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
Yes. The generic name for Entresto is sacubitril and valsartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Entresto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 24MG;26MG | Marketed (Rx) | AB | 16 | AB |
| tablet, oral | 49MG;51MG | Marketed (Rx) | AB | 16 | AB |
| tablet, oral | 97MG;103MG | Marketed (Rx) | AB | 16 | AB |
NDA 207620, 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.
Approved generic sacubitril and valsartan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 213682 | AB (A-rated, therapeutically equivalent) | May 28, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| CRYSTAL PHARMACEUTICAL SUZHOU CO LTD | 213605 | AB (A-rated, therapeutically equivalent) | May 28, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| LAURUS LABS LTD | 213676 | AB (A-rated, therapeutically equivalent) | May 28, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| ZYDUS PHARMACEUTICALS USA INC | 213719 | AB (A-rated, therapeutically equivalent) | July 9, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| TORRENT PHARMACEUTICALS LTD | 213604 | AB (A-rated, therapeutically equivalent) | August 22, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| BIOCON PHARMA LTD | 213680 | AB (A-rated, therapeutically equivalent) | August 30, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| ALKEM LABORATORIES LTD | 213764 | AB (A-rated, therapeutically equivalent) | September 16, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| MACLEODS PHARMACEUTICALS LTD | 213728 | AB (A-rated, therapeutically equivalent) | October 16, 2024 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| LUPIN INC | 213808 | AB (A-rated, therapeutically equivalent) | January 8, 2025 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| DR REDDYS LABORATORIES LTD | 213627 | AB (A-rated, therapeutically equivalent) | January 13, 2025 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| MSN LABORATORIES PRIVATE LTD | 213748 | AB (A-rated, therapeutically equivalent) | July 16, 2025 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| NOVUGEN PHARMA SDN BHD | 213611 | AB (A-rated, therapeutically equivalent) | July 16, 2025 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| HETERO LABS LTD UNIT III | 213668 | AB (A-rated, therapeutically equivalent) | July 17, 2025 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| SOMERSET THERAPEUTICS LLC | 219983 | AB (A-rated, therapeutically equivalent) | January 20, 2026 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| UMEDICA LABORATORIES PRIVATE LTD | 219946 | AB (A-rated, therapeutically equivalent) | August 4, 2026 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
| AUROBINDO PHARMA LTD | 213631 | AB (A-rated, therapeutically equivalent) | September 2, 2026 | 24MG;26MG, 49MG;51MG, 97MG;103MG |
Entresto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9388134 | November 8, 2026 | Method of use | U-1723 | 207620 |
| 9388134*PED | May 8, 2027 | Method of use | None | 207620 |
| 8877938 | May 27, 2027 | Drug substance, Drug product | None | 207620 |
| 8877938*PED | November 27, 2027 | Method of use | None | 207620 |
| 11135192 | August 22, 2033 | Method of use | U-3084 | 207620 |
| 9517226 | August 22, 2033 | Method of use | U-3084 | 207620 |
| 9937143 | August 22, 2033 | Method of use | U-3084 | 207620 |
| 11058667 | May 9, 2036 | Method of use | U-3170 | 207620 |
Entresto NDC codes
Questions
Is there a generic for Entresto?
Yes. The generic name for Entresto is sacubitril and valsartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Entresto?
The active ingredient in Entresto is sacubitril and valsartan, per the FDA Orange Book.
When does the Entresto patent expire?
The last patent listed for Entresto in the Orange Book expires May 9, 2036. 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.
More on Entresto and Sacubitril and Valsartan
- What is Entresto used for?FDA label uses
- Is Entresto a controlled substance?Federal schedule
- Generic for Entresto SprinkleFDA Orange Book
- Angiotensin 2 Receptor Blockers listFDA drug class
- Neprilysin Inhibitors listFDA drug class
- Entresto Medicare Part D coverageBy plan and state
- NDC 0078-0659Entresto NDC record
- NDC 0078-0696Entresto NDC record
- NDC 0078-0777Entresto NDC record