FDA Orange Book
Generic for Quartette
Quartette 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 Quartette is levonorgestrel and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Quartette products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | Marketed (Rx) | AB | 1 | AB |
NDA 204061, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC. 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 |
|---|---|---|---|---|
| XIROMED LLC | 206053 | AB (A-rated, therapeutically equivalent) | October 2, 2017 | 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A |
Quartette patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8415332 | March 11, 2029 | Drug product | None | 204061 |
Questions
Is there a generic for Quartette?
Yes. The generic name for Quartette is levonorgestrel and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Quartette?
The active ingredient in Quartette is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
When does the Quartette patent expire?
The last patent listed for Quartette in the Orange Book expires March 11, 2029. 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.