FDA Orange Book
Generic for Vivelle
Vivelle 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 Vivelle 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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Vivelle 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 020323, held by SANDOZ 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 Vivelle?
Yes. The generic name for Vivelle 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 Vivelle?
The active ingredient in Vivelle 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.