Orange Book product · Brand (NDA)
UBRELVY
UBROGEPANT
At a glance
Dec 23, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2019
6 yr 7 mo ago
Today
Patent 9499545 expires
Listed drug substance patent expiration.
Nov 10, 2031
in 5 yr 6 mo
Patent 9833448 expires
Listed method-of-use patent (U-2718) expiration.
Nov 10, 2031
in 5 yr 6 mo
Patent 8754096 expires
Listed drug substance patent expiration.
Jul 19, 2032
in 6 yr 2 mo
Patent 8912210 expires
Listed drug substance patent expiration.
Dec 23, 2033
in 7 yr 7 mo
Patent 10117836 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 11925709 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 12168004 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 12220408 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 12310953 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 12458632 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 12458633 expires
Listed drug product patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 11717515 expires
Listed method-of-use patent (U-3677) expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 11857542 expires
Listed method-of-use patent (U-3786) expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12194030 expires
Listed method-of-use patent (U-4121) expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12194030 expires
Listed method-of-use patent (U-4122) expiration.
Dec 22, 2041
in 15 yr 9 mo
Patent 12329750 expires
Listed method-of-use patent (U-4213) expiration.
Dec 22, 2041
in 15 yr 9 mo
Pharmaceutical detail
Active ingredient
UBROGEPANT
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211765
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9499545 | Nov 10, 2031 | in 5 yr 6 mo | SubstanceProductU-2718 |
| 9833448 | Nov 10, 2031 | in 5 yr 6 mo | U-2718 |
| 8754096 | Jul 19, 2032 | in 6 yr 2 mo | SubstanceProductU-2717 |
| 8912210 | Dec 23, 2033 | in 7 yr 7 mo | SubstanceProduct |
| 10117836 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 11925709 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 12168004 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 12220408 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 12310953 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 12458632 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 12458633 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 11717515 | Dec 22, 2041 | in 15 yr 9 mo | U-3677 |
| 11857542 | Dec 22, 2041 | in 15 yr 9 mo | U-3786 |
| 12194030 | Dec 22, 2041 | in 15 yr 9 mo | U-4121 |
| 12194030 | Dec 22, 2041 | in 15 yr 9 mo | U-4122 |
| 12329750 | Dec 22, 2041 | in 15 yr 9 mo | U-4213 |
