FDA Orange Book · active-ingredient family
Brensocatib
Brensocatib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BRINSUPRI · NDA 217673
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRINSUPRIRLD×2 | INSMED INC | NDA 217673 | — | Aug 12, 2025 |
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Aug 12, 2030
in 4 yr 3 mo
- NCENew chemical entity exclusivity (5 years)
Aug 12, 2030
in 4 yr 3 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12054465 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11814359 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11773069 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11673871 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11655224 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 11655223 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11655222 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 11655221 | Jan 21, 2035 | in 8 yr 9 mo | ProductU-4257 |
| 10669245 | Jan 21, 2035 | in 8 yr 9 mo | SubstanceU-4257 |
| 10287258 | 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 |
Brensocatib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
