FDA Orange Book
Is there a generic for Femlyv?
Femlyv contains norethindrone acetate 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 Femlyv (norethindrone acetate and ethinyl estradiol). The Orange Book shows its last listed patent expires June 24, 2041 and its last listed exclusivity ends July 22, 2027.
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Femlyv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 0.02MG;1MG | Marketed (Rx) | None | 0 | None |
NDA 218718, held by MILLICENT MANUFACTURING PR LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Femlyv patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12178824 | June 24, 2041 | Drug product | None | 218718 |
Femlyv exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | July 22, 2027 | 218718 |
Questions
Is there a generic for Femlyv?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Femlyv (norethindrone acetate and ethinyl estradiol). The Orange Book shows its last listed patent expires June 24, 2041 and its last listed exclusivity ends July 22, 2027.
What is the generic name for Femlyv?
The active ingredient in Femlyv is norethindrone acetate and ethinyl estradiol, per the FDA Orange Book.
When does the Femlyv patent expire?
The last patent listed for Femlyv in the Orange Book expires June 24, 2041. 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.