FDA Orange Book
Generic for Alora
Alora 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 Alora is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2, AB3.
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Alora products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 0.025MG/24HR | Discontinued | None | 4 | AB2, AB3 |
| film, extended release, transdermal | 0.05MG/24HR | Discontinued | None | 4 | AB2, AB3 |
| film, extended release, transdermal | 0.075MG/24HR | Discontinued | None | 4 | AB2, AB3 |
| film, extended release, transdermal | 0.1MG/24HR | Discontinued | None | 4 | AB2, AB3 |
NDA 020655, 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 estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN TECHNOLOGIES INC | 075182 | AB2 (A-rated, therapeutically equivalent) | January 26, 2005 | 0.025MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
| MYLAN TECHNOLOGIES INC | 206685 | AB3 (A-rated, therapeutically equivalent) | August 15, 2018 | 0.025MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
| AMNEAL PHARMACEUTICALS LLC | 211396 | AB3 (A-rated, therapeutically equivalent) | September 28, 2020 | 0.025MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
| ZYDUS PHARMACEUTICALS USA INC | 202985 | AB2 (A-rated, therapeutically equivalent) | March 29, 2023 | 0.025MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR |
Questions
Is there a generic for Alora?
Yes. The generic name for Alora is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2, AB3.
What is the generic name for Alora?
The active ingredient in Alora 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.