FDA Orange Book
Generic for Seasonique
Seasonique 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 Seasonique is levonorgestrel and ethinyl estradiol. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Seasonique products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.03MG,0.01MG;0.15MG,N/A | Marketed (Rx) | AB | 7 | AB |
NDA 021840, 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 |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 078834 | AB (A-rated, therapeutically equivalent) | May 31, 2011 | 0.03MG,0.01MG;0.15MG,N/A |
| LUPIN LTD | 091467 | AB (A-rated, therapeutically equivalent) | April 10, 2013 | 0.03MG,0.01MG;0.15MG,N/A |
| GLENMARK PHARMACEUTICALS LTD | 203163 | AB (A-rated, therapeutically equivalent) | February 23, 2015 | 0.03MG,0.01MG;0.15MG,N/A |
| XIROMED LLC | 200492 | AB (A-rated, therapeutically equivalent) | May 27, 2015 | 0.03MG,0.01MG;0.15MG,N/A |
| NAARI PTE LTD | 203872 | AB (A-rated, therapeutically equivalent) | December 22, 2015 | 0.03MG,0.01MG;0.15MG,N/A |
| AUROBINDO PHARMA LTD | 206851 | AB (A-rated, therapeutically equivalent) | April 7, 2017 | 0.03MG,0.01MG;0.15MG,N/A |
| XIROMED PHARMA ESPANA SL | 203770 | AB (A-rated, therapeutically equivalent) | December 27, 2017 | 0.03MG,0.01MG;0.15MG,N/A |
Seasonique patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7855190 | December 5, 2028 | Method of use | U-1 | 021840 |
Questions
Is there a generic for Seasonique?
Yes. The generic name for Seasonique is levonorgestrel and ethinyl estradiol. 7 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 Seasonique?
The active ingredient in Seasonique is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
When does the Seasonique patent expire?
The last patent listed for Seasonique 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.