FDA Orange Book
Is there a generic for Qutenza?
Qutenza contains capsaicin. 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 Qutenza (capsaicin). The Orange Book shows its last listed patent expires March 26, 2030.
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Qutenza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| patch, topical | 8% | Marketed (Rx) | None | 0 | None |
NDA 022395, held by AVERITAS PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qutenza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9226903 | December 15, 2028 | Drug product | None | 022395 |
| 8821920 | March 26, 2030 | Drug product | None | 022395 |
Questions
Is there a generic for Qutenza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qutenza (capsaicin). The Orange Book shows its last listed patent expires March 26, 2030.
What is the generic name for Qutenza?
The active ingredient in Qutenza is capsaicin, per the FDA Orange Book.
When does the Qutenza patent expire?
The last patent listed for Qutenza in the Orange Book expires March 26, 2030. 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.