FDA Orange Book
Is there a generic for Yupelri?
Yupelri contains revefenacin. 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 Yupelri (revefenacin). The Orange Book shows its last listed patent expires October 23, 2039.
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Yupelri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | 175MCG/3ML | Marketed (Rx) | None | 0 | None |
NDA 210598, held by MYLAN IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Yupelri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7288657 | October 31, 2028 | Drug substance | None | 210598 |
| 11008289 | July 14, 2030 | Method of use | U-2440 | 210598 |
| 11858898 | July 14, 2030 | Drug substance, Drug product | U-2440 | 210598 |
| 10550081 | July 14, 2030 | Drug substance | None | 210598 |
| 9765028 | July 14, 2030 | Drug substance | None | 210598 |
| 11691948 | July 14, 2030 | Drug product | None | 210598 |
| 8541451 | August 25, 2031 | Drug substance | None | 210598 |
| 12285417 | August 29, 2039 | Method of use | U-2440 | 210598 |
| 12048692 | August 29, 2039 | Method of use | U-2440 | 210598 |
| 11484531 | October 23, 2039 | Method of use | U-2440 | 210598 |
Yupelri NDC codes
Questions
Is there a generic for Yupelri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yupelri (revefenacin). The Orange Book shows its last listed patent expires October 23, 2039.
What is the generic name for Yupelri?
The active ingredient in Yupelri is revefenacin, per the FDA Orange Book.
When does the Yupelri patent expire?
The last patent listed for Yupelri in the Orange Book expires October 23, 2039. 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.