FDA Orange Book
Generic for Ortho Evra
Ortho Evra contains norelgestromin and ethinyl 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 Ortho Evra is norelgestromin and ethinyl estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ortho Evra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 0.035MG/24HR;0.15MG/24HR | Discontinued | None | 4 | AB |
NDA 021180, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic norelgestromin and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN TECHNOLOGIES INC | 200910 | AB (A-rated, therapeutically equivalent) | April 16, 2014 | 0.035MG/24HR;0.15MG/24HR |
| AMNEAL PHARMACEUTICALS LLC | 213950 | AB (A-rated, therapeutically equivalent) | February 25, 2021 | 0.035MG/24HR;0.15MG/24HR |
| TEVA PHARMACEUTICALS USA INC | 213977 | AB (A-rated, therapeutically equivalent) | August 25, 2021 | 0.035MG/24HR;0.15MG/24HR |
| ZYDUS PHARMACEUTICALS USA INC | 214594 | AB (A-rated, therapeutically equivalent) | September 14, 2023 | 0.035MG/24HR;0.15MG/24HR |
Questions
Is there a generic for Ortho Evra?
Yes. The generic name for Ortho Evra is norelgestromin and ethinyl estradiol. 4 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 Ortho Evra?
The active ingredient in Ortho Evra is norelgestromin and ethinyl 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.