FDA Orange Book
Generic for Loseasonique
Loseasonique 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 Loseasonique is levonorgestrel 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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Loseasonique products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG,0.1MG;0.01MG,N/A | Marketed (Rx) | AB | 4 | AB |
NDA 022262, 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 levonorgestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LIMITED | 091674 | AB (A-rated, therapeutically equivalent) | October 26, 2011 | 0.02MG,0.1MG;0.01MG,N/A |
| XIROMED LLC | 200493 | AB (A-rated, therapeutically equivalent) | June 17, 2015 | 0.02MG,0.1MG;0.01MG,N/A |
| AUROBINDO PHARMA LTD | 206852 | AB (A-rated, therapeutically equivalent) | April 28, 2017 | 0.02MG,0.1MG;0.01MG,N/A |
| XIROMED PHARMA ESPANA SL | 205131 | AB (A-rated, therapeutically equivalent) | December 14, 2017 | 0.02MG,0.1MG;0.01MG,N/A |
Loseasonique patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7855190 | December 5, 2028 | Method of use | U-1 | 022262 |
Questions
Is there a generic for Loseasonique?
Yes. The generic name for Loseasonique is levonorgestrel 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 Loseasonique?
The active ingredient in Loseasonique is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
When does the Loseasonique patent expire?
The last patent listed for Loseasonique in the Orange Book expires December 5, 2028. A listed patent expiry date is not a generic launch date.
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.