FDA Orange Book
Generic for Angeliq
Angeliq contains drospirenone and 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 Angeliq is drospirenone and estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Angeliq products the Orange Book lists.
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Angeliq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.25MG;0.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.5MG;1MG | Marketed (Rx) | AB | 1 | AB |
NDA 021355, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic drospirenone and estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVAST LABORATORIES LTD | 218031 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 0.5MG;1MG |
Angeliq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8906890 | October 22, 2031 | Drug product | None | 021355 |
Angeliq NDC codes
Questions
Is there a generic for Angeliq?
Yes. The generic name for Angeliq is drospirenone and estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Angeliq products the Orange Book lists.
What is the generic name for Angeliq?
The active ingredient in Angeliq is drospirenone and estradiol, per the FDA Orange Book.
When does the Angeliq patent expire?
The last patent listed for Angeliq in the Orange Book expires October 22, 2031. 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.