FDA Orange Book
Generic for Alesse
Alesse contains levonorgestrel 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 Alesse is levonorgestrel and ethinyl estradiol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2. Generics match 1 of the 2 Alesse products the Orange Book lists.
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Alesse products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.02MG;0.1MG | Discontinued | None | 0 | None |
| tablet, oral-28 | 0.02MG;0.1MG | Discontinued | None | 11 | AB1, AB2 |
NDA 020683, held by CADENCE HEALTH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levonorgestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC | 075796 | AB1 (A-rated, therapeutically equivalent) | April 30, 2001 | 0.02MG;0.1MG |
| BARR LABORATORIES INC | 075803 | AB2 (A-rated, therapeutically equivalent) | March 20, 2002 | 0.02MG;0.1MG |
| DR REDDYS LABORATORIES SA | 076625 | AB1 (A-rated, therapeutically equivalent) | November 18, 2004 | 0.02MG;0.1MG |
| DR REDDYS LABORATORIES SA | 077681 | AB2 (A-rated, therapeutically equivalent) | May 31, 2006 | 0.02MG;0.1MG |
| NOVAST LABORATORIES LTD | 090721 | AB1 (A-rated, therapeutically equivalent) | March 28, 2012 | 0.02MG;0.1MG |
| LUPIN LTD | 091425 | AB1 (A-rated, therapeutically equivalent) | January 18, 2013 | 0.02MG;0.1MG |
| XIROMED LLC | 200245 | AB1 (A-rated, therapeutically equivalent) | October 9, 2013 | 0.02MG;0.1MG |
| XIROMED PHARMA ESPANA SL | 201088 | AB1 (A-rated, therapeutically equivalent) | May 21, 2015 | 0.02MG;0.1MG |
| AUROBINDO PHARMA LTD | 206886 | AB1 (A-rated, therapeutically equivalent) | November 14, 2016 | 0.02MG;0.1MG |
| NAARI PTE LTD | 207065 | AB1 (A-rated, therapeutically equivalent) | August 17, 2020 | 0.02MG;0.1MG |
| HETERO LABS LTD | 212298 | AB1 (A-rated, therapeutically equivalent) | February 13, 2023 | 0.02MG;0.1MG |
Questions
Is there a generic for Alesse?
Yes. The generic name for Alesse is levonorgestrel and ethinyl estradiol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2. Generics match 1 of the 2 Alesse products the Orange Book lists.
What is the generic name for Alesse?
The active ingredient in Alesse is levonorgestrel 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.