FDA Orange Book
Generic for Balcoltra
Balcoltra 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 Balcoltra is levonorgestrel and ethinyl estradiol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB3.
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Balcoltra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG;0.1MG | Marketed (Rx) | AB3 | 2 | AB3 |
NDA 208612, held by AVION PHARMACEUTICALS 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 PHARMA ESPANA SL | 214640 | AB3 (A-rated, therapeutically equivalent) | August 16, 2023 | 0.02MG;0.1MG |
| LUPIN LTD | 217087 | AB3 (A-rated, therapeutically equivalent) | February 15, 2024 | 0.02MG;0.1MG |
Balcoltra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7838042 | June 1, 2027 | Drug substance | U-3251 | 208612 |
Questions
Is there a generic for Balcoltra?
Yes. The generic name for Balcoltra is levonorgestrel and ethinyl estradiol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB3.
What is the generic name for Balcoltra?
The active ingredient in Balcoltra is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
When does the Balcoltra patent expire?
The last patent listed for Balcoltra in the Orange Book expires June 1, 2027. 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.