FDA Orange Book · active-ingredient family
Revefenacin
Revefenacin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:YUPELRI · NDA 210598
1
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| YUPELRIRLD | MYLAN IRELAND LTD | NDA 210598 | — | Nov 09, 2018 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7288657 | Oct 31, 2028 | in 2 yr 5 mo | Substance |
| 11008289 | Jul 14, 2030 | in 4 yr 2 mo | U-2440 |
| 11858898 | Jul 14, 2030 | in 4 yr 2 mo | SubstanceProductU-2440 |
| 10550081 | Jul 14, 2030 | in 4 yr 2 mo | Substance |
| 9765028 | Jul 14, 2030 | in 4 yr 2 mo | Substance |
| 11691948 | Jul 14, 2030 | in 4 yr 2 mo | Product |
| 8541451 | Aug 25, 2031 | in 5 yr 3 mo | Substance |
| 12285417 | Aug 29, 2039 | in 13 yr 5 mo | U-2440 |
| 12048692 | Aug 29, 2039 | in 13 yr 5 mo | U-2440 |
| 11484531 | Oct 23, 2039 | in 13 yr 6 mo | U-2440 |
Revefenacin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
