FDA Orange Book
Generic for Enablex
Enablex contains darifenacin. 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 Enablex is darifenacin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Enablex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 15MG BASE | Discontinued | None | 6 | AB |
| tablet, extended release, oral | EQ 7.5MG BASE | Discontinued | None | 6 | AB |
NDA 021513, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic darifenacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CIPLA LTD | 207664 | AB (A-rated, therapeutically equivalent) | September 1, 2016 | EQ 15MG BASE, EQ 7.5MG BASE |
| AUROBINDO PHARMA LTD | 206743 | AB (A-rated, therapeutically equivalent) | September 19, 2016 | EQ 15MG BASE, EQ 7.5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 205209 | AB (A-rated, therapeutically equivalent) | November 17, 2016 | EQ 15MG BASE, EQ 7.5MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 207302 | AB (A-rated, therapeutically equivalent) | July 28, 2017 | EQ 15MG BASE, EQ 7.5MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 207681 | AB (A-rated, therapeutically equivalent) | December 8, 2017 | EQ 15MG BASE, EQ 7.5MG BASE |
| ALICORA INC | 211045 | AB (A-rated, therapeutically equivalent) | January 6, 2020 | EQ 15MG BASE, EQ 7.5MG BASE |
Questions
Is there a generic for Enablex?
Yes. The generic name for Enablex is darifenacin. 6 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 Enablex?
The active ingredient in Enablex is darifenacin, per the FDA Orange Book.
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.