Prescription medicine
Brensocatib Brand names: Brinsupri
Brensocatib (Brinsupri) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the brensocatib FDA label on DailyMed (effective March 16, 2026, Insmed Incorporated); the NDA 217673 record on Drugs@FDA; every brensocatib label on DailyMed.
Highlights of the record
FDA label of March 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.
Forms and strengths
- 10 mg
- 25 mg
Tablet.
On the market
- Earliest approval on file
- August 12, 2025 Brinsupri, Insmed Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 21, 2040 Brinsupri tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,017 through July 30, 2026
What is brensocatib used for?
From the label: indications and usageBRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.
Source: FDA drug label (Brinsupri), Insmed Incorporated, effective March 16, 2026 (SPL set b56986ae-e7db-421e-b622-a7f41e321f3d), via openFDA; the full label on DailyMed
Is there a generic for brensocatib (Brinsupri)?
No generic brensocatib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Brinsupri tablets: the compound patent runs to March 12, 2035, and the last listed entry to February 21, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for brensocatib?
The FDA Adverse Event Reporting System holds 2,017 reports that list brensocatib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 257 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Brensocatib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other