FDA Orange Book
Generic for Esclim
Esclim contains estradiol. 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 Esclim is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.
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Esclim products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, transdermal | 0.025MG/24HR | Discontinued | None | 3 | AB1 |
| system, transdermal | 0.0375MG/24HR | Discontinued | None | 3 | AB1 |
| system, transdermal | 0.05MG/24HR | Discontinued | None | 3 | AB1 |
| system, transdermal | 0.075MG/24HR | Discontinued | None | 3 | AB1 |
| system, transdermal | 0.1MG/24HR | Discontinued | None | 3 | AB1 |
NDA 020847, held by WOMEN FIRST HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN TECHNOLOGIES INC | 201675 | AB1 (A-rated, therapeutically equivalent) | December 19, 2014 | 0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
| AMNEAL PHARMACEUTICALS LLC | 211293 | AB1 (A-rated, therapeutically equivalent) | February 4, 2019 | 0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
| ZYDUS PHARMACEUTICALS USA INC | 206241 | AB1 (A-rated, therapeutically equivalent) | December 1, 2022 | 0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
Questions
Is there a generic for Esclim?
Yes. The generic name for Esclim is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.
What is the generic name for Esclim?
The active ingredient in Esclim is estradiol, 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.