FDA Orange Book
Generic for Mircette
Mircette contains desogestrel 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 Mircette is desogestrel and ethinyl estradiol. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mircette products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.15MG,N/A;0.02MG,0.01MG | Discontinued | None | 9 | AB |
NDA 020713, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desogestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 075863 | AB (A-rated, therapeutically equivalent) | April 5, 2002 | 0.15MG,N/A;0.02MG,0.01MG |
| GLENMARK PHARMACEUTICALS LTD | 091346 | AB (A-rated, therapeutically equivalent) | April 2, 2012 | 0.15MG,N/A;0.02MG,0.01MG |
| NOVAST LABORATORIES LTD | 091247 | AB (A-rated, therapeutically equivalent) | August 1, 2013 | 0.15MG,N/A;0.02MG,0.01MG |
| XIROMED LLC | 202296 | AB (A-rated, therapeutically equivalent) | August 30, 2013 | 0.15MG,N/A;0.02MG,0.01MG |
| LUPIN LTD | 202226 | AB (A-rated, therapeutically equivalent) | August 12, 2015 | 0.15MG,N/A;0.02MG,0.01MG |
| XIROMED PHARMA ESPANA SL | 202689 | AB (A-rated, therapeutically equivalent) | September 9, 2016 | 0.15MG,N/A;0.02MG,0.01MG |
| AUROBINDO PHARMA LTD | 206853 | AB (A-rated, therapeutically equivalent) | March 22, 2017 | 0.15MG,N/A;0.02MG,0.01MG |
| NAARI PTE LTD | 209170 | AB (A-rated, therapeutically equivalent) | June 5, 2017 | 0.15MG,N/A;0.02MG,0.01MG |
| ANNORA PHARMA PRIVATE LTD | 219670 | AB (A-rated, therapeutically equivalent) | July 7, 2026 | 0.15MG,N/A;0.02MG,0.01MG |
Questions
Is there a generic for Mircette?
Yes. The generic name for Mircette is desogestrel and ethinyl estradiol. 9 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 Mircette?
The active ingredient in Mircette is desogestrel 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.