Orange Book product · Brand (NDA)
YUPELRI
REVEFENACIN
At a glance
Nov 09, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2018
7 yr 9 mo ago
Today
Patent 7288657 expires
Listed drug substance patent expiration.
Oct 31, 2028
in 2 yr 5 mo
Patent 10550081 expires
Listed drug substance patent expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 11008289 expires
Listed method-of-use patent (U-2440) expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 11691948 expires
Listed drug product patent expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 11858898 expires
Listed drug substance patent expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 9765028 expires
Listed drug substance patent expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 8541451 expires
Listed drug substance patent expiration.
Aug 25, 2031
in 5 yr 3 mo
Patent 12048692 expires
Listed method-of-use patent (U-2440) expiration.
Aug 29, 2039
in 13 yr 5 mo
Patent 12285417 expires
Listed method-of-use patent (U-2440) expiration.
Aug 29, 2039
in 13 yr 5 mo
Patent 11484531 expires
Listed method-of-use patent (U-2440) expiration.
Oct 23, 2039
in 13 yr 6 mo
Pharmaceutical detail
Active ingredient
REVEFENACIN
Strength
175MCG/3ML
Dosage form
SOLUTION
Route
INHALATION
TE code
Not listed
Application
NDA 210598
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7288657 | Oct 31, 2028 | in 2 yr 5 mo | Substance |
| 10550081 | Jul 14, 2030 | in 4 yr 2 mo | Substance |
| 11008289 | Jul 14, 2030 | in 4 yr 2 mo | U-2440 |
| 11691948 | Jul 14, 2030 | in 4 yr 2 mo | Product |
| 11858898 | Jul 14, 2030 | in 4 yr 2 mo | SubstanceProductU-2440 |
| 9765028 | Jul 14, 2030 | in 4 yr 2 mo | Substance |
| 8541451 | Aug 25, 2031 | in 5 yr 3 mo | Substance |
| 12048692 | Aug 29, 2039 | in 13 yr 5 mo | U-2440 |
| 12285417 | Aug 29, 2039 | in 13 yr 5 mo | U-2440 |
| 11484531 | Oct 23, 2039 | in 13 yr 6 mo | U-2440 |

