FDA Orange Book
Is there a generic for Addyi?
Addyi contains flibanserin. 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 Addyi (flibanserin). The Orange Book shows its last listed patent expires May 9, 2028 and its last listed exclusivity ends December 13, 2028.
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Addyi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 022526, held by SPROUT PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Addyi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7151103 | May 9, 2028 | Method of use | U-1734 | 022526 |
Addyi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-983 | New indication | December 13, 2028 | 022526 |
Addyi NDC codes
Questions
Is there a generic for Addyi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Addyi (flibanserin). The Orange Book shows its last listed patent expires May 9, 2028 and its last listed exclusivity ends December 13, 2028.
What is the generic name for Addyi?
The active ingredient in Addyi is flibanserin, per the FDA Orange Book.
When does the Addyi patent expire?
The last patent listed for Addyi in the Orange Book expires May 9, 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.