FDA Orange Book
Is there a generic for Qbrexza?
Qbrexza contains glycopyrronium. 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 Qbrexza (glycopyrronium). The Orange Book shows its last listed patent expires February 28, 2033.
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Qbrexza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cloth, topical | EQ 2.4% BASE | Marketed (Rx) | None | 0 | None |
NDA 210361, held by JOURNEY MEDICAL CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qbrexza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10052267 | October 17, 2028 | Drug product | U-2398 | 210361 |
| 8618160 | December 10, 2029 | Drug product | U-2398 | 210361 |
| 9744105 | July 18, 2030 | Drug product | U-2398 | 210361 |
| 8859610 | February 28, 2033 | Drug product | U-2398 | 210361 |
| 9259414 | February 28, 2033 | Method of use | U-2398 | 210361 |
| 10004717 | February 28, 2033 | Drug product | U-2398 | 210361 |
| 10548875 | February 28, 2033 | Drug substance, Drug product | U-2398 | 210361 |
| 10543192 | February 28, 2033 | Drug product | None | 210361 |
Qbrexza NDC codes
Questions
Is there a generic for Qbrexza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qbrexza (glycopyrronium). The Orange Book shows its last listed patent expires February 28, 2033.
What is the generic name for Qbrexza?
The active ingredient in Qbrexza is glycopyrronium, per the FDA Orange Book.
When does the Qbrexza patent expire?
The last patent listed for Qbrexza in the Orange Book expires February 28, 2033. 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.