FDA Orange Book
Is there a generic for Twirla?
Twirla 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Twirla (levonorgestrel and ethinyl estradiol). The Orange Book shows its last listed patent expires August 26, 2028.
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Twirla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, transdermal | 0.01MG/24HR;0.04MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 204017, held by AGILE THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Twirla patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8747888 | July 10, 2028 | Drug product | None | 204017 |
| 9050348 | July 10, 2028 | Drug product | None | 204017 |
| 8246978 | August 26, 2028 | Drug product | None | 204017 |
Twirla NDC codes
Questions
Is there a generic for Twirla?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Twirla (levonorgestrel and ethinyl estradiol). The Orange Book shows its last listed patent expires August 26, 2028.
What is the generic name for Twirla?
The active ingredient in Twirla is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
When does the Twirla patent expire?
The last patent listed for Twirla in the Orange Book expires August 26, 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.
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