Orange Book product · Brand (NDA)
BRINSUPRI
BRENSOCATIB
At a glance
Aug 12, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 2025
10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 12, 2030
in 4 yr 3 mo
Patent 10287258 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 10669245 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11655221 expires
Listed drug product patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11655222 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11655223 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11655224 expires
Listed drug product patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11673871 expires
Listed drug product patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11773069 expires
Listed drug product patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11814359 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 12054465 expires
Listed drug substance patent expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 9815805 expires
Listed method-of-use patent (U-4257) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 9522894 expires
Listed drug substance patent expiration.
Mar 12, 2035
in 8 yr 10 mo
Patent 12201638 expires
Listed drug product patent expiration.
Mar 01, 2039
in 12 yr 11 mo
Patent 12059424 expires
Listed drug product patent expiration.
Feb 21, 2040
in 13 yr 11 mo
Pharmaceutical detail
Active ingredient
BRENSOCATIB
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217673
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)
- NCENew chemical entity exclusivity (5 years)
Aug 12, 2030
in 4 yr 3 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10287258 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 10669245 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11655221 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11655222 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11655223 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11655224 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11673871 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11773069 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11814359 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 12054465 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 9815805 | Jan 21, 2035 | in 8 yr 9 mo | U-4257 |
| 9522894 | Mar 12, 2035 | in 8 yr 10 mo | Substance |
| 12201638 | Mar 01, 2039 | in 12 yr 11 mo | Product |
| 12059424 | Feb 21, 2040 | in 13 yr 11 mo | Product |
