Orange Book product · Brand (NDA)
ALUNBRIG
BRIGATINIB
At a glance
Apr 28, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2017
9 yr 3 mo ago
Today
Exclusivity ends · ODE-300
Orphan-drug exclusivity (7 years)
May 22, 2027
in 11 mo
Patent 9273077 expires
Listed method-of-use patent (U-2837) expiration.
May 21, 2029
in 3 yr
Patent 9012462 expires
Listed drug substance patent expiration.
Apr 28, 2031
in 4 yr 11 mo
Patent 9611283 expires
Listed method-of-use patent (U-2837) expiration.
Apr 10, 2034
in 7 yr 11 mo
Patent 10385078 expires
Listed drug substance patent expiration.
Nov 10, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
BRIGATINIB
Strength
30MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208772
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.
Marketing exclusivity (1)
- ODE-300Orphan-drug exclusivity (7 years)
May 22, 2027
in 11 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9273077 | May 21, 2029 | in 3 yr | U-2837 |
| 9012462 | Apr 28, 2031 | in 4 yr 11 mo | Substance |
| 9611283 | Apr 10, 2034 | in 7 yr 11 mo | U-2837 |
| 10385078 | Nov 10, 2035 | in 9 yr 6 mo | SubstanceProductU-2837 |
