FDA Orange Book
Generic for Brisdelle
Brisdelle contains paroxetine. 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 Brisdelle is paroxetine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Brisdelle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 7.5MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 204516, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic paroxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 207139 | AB (A-rated, therapeutically equivalent) | June 20, 2017 | EQ 7.5MG BASE |
| PRINSTON PHARMACEUTICAL INC | 207188 | AB (A-rated, therapeutically equivalent) | August 18, 2017 | EQ 7.5MG BASE |
Brisdelle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8946251 | August 4, 2026 | Drug substance, Drug product | U-904 | 204516 |
| 9393237 | August 4, 2026 | Method of use | U-904 | 204516 |
| 8658663 | April 6, 2029 | Drug substance, Drug product | U-904 | 204516 |
Brisdelle NDC codes
Questions
Is there a generic for Brisdelle?
Yes. The generic name for Brisdelle is paroxetine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Brisdelle?
The active ingredient in Brisdelle is paroxetine, per the FDA Orange Book.
When does the Brisdelle patent expire?
The last patent listed for Brisdelle in the Orange Book expires April 6, 2029. 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.