FDA Orange Book
Generic for Epaned
Epaned contains enalapril. 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 Epaned is enalapril. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Epaned products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/ML | Marketed (Rx) | AB | 5 | AB |
NDA 208686, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic enalapril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BIONPHARMA INC | 212408 | AB (A-rated, therapeutically equivalent) | August 10, 2021 | 1MG/ML |
| ANNORA PHARMA PRIVATE LTD | 214467 | AB (A-rated, therapeutically equivalent) | February 24, 2022 | 1MG/ML |
| ALKEM LABORATORIES LTD | 213714 | AB (A-rated, therapeutically equivalent) | March 30, 2022 | 1MG/ML |
| AMNEAL PHARMACEUTICALS LLC | 212894 | AB (A-rated, therapeutically equivalent) | June 29, 2022 | 1MG/ML |
| AUROBINDO PHARMA LTD | 216458 | AB (A-rated, therapeutically equivalent) | January 8, 2024 | 1MG/ML |
Epaned patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9808442 | March 25, 2036 | Method of use | U-71 | 208686 |
| 9808442 | March 25, 2036 | Method of use | U-1723 | 208686 |
| 9808442 | March 25, 2036 | Method of use | U-185 | 208686 |
| 10154987 | March 25, 2036 | Method of use | U-3 | 208686 |
| 10154987 | March 25, 2036 | Method of use | U-1892 | 208686 |
| 10154987 | March 25, 2036 | Method of use | U-185 | 208686 |
| 10154987 | March 25, 2036 | Method of use | U-71 | 208686 |
| 9808442 | March 25, 2036 | Method of use | U-1892 | 208686 |
| 9808442 | March 25, 2036 | Method of use | U-3 | 208686 |
| 10154987 | March 25, 2036 | Method of use | U-1723 | 208686 |
| 11040023 | March 25, 2036 | Drug product | None | 208686 |
| 9669008 | March 25, 2036 | Drug product | None | 208686 |
| 10772868 | March 25, 2036 | Drug product | None | 208686 |
| 10786482 | March 25, 2036 | Drug product | None | 208686 |
| 10039745 | March 25, 2036 | Drug product | None | 208686 |
| 11173141 | March 25, 2036 | Drug product | None | 208686 |
| 11141405 | March 25, 2036 | Drug product | None | 208686 |
Epaned NDC codes
Questions
Is there a generic for Epaned?
Yes. The generic name for Epaned is enalapril. 5 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 Epaned?
The active ingredient in Epaned is enalapril, per the FDA Orange Book.
When does the Epaned patent expire?
The last patent listed for Epaned in the Orange Book expires March 25, 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.