BRINSUPRI — FDA application NDA217673
Listed sponsor: INSMED INC · INSM company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | BRINSUPRI | BRENSOCATIB | TABLET | ORAL | 10MG | Prescription | not listed | Yes |
| 002 | BRINSUPRI | BRENSOCATIB | TABLET | ORAL | 25MG | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10287258 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 10287258 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 10669245 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 10669245 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11655221 | 001 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11655221 | 002 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11655222 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11655222 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11655223 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11655223 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11655224 | 001 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11655224 | 002 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11673871 | 001 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11673871 | 002 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11773069 | 001 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11773069 | 002 | listed patent expiry date: 2035-01-21 | drug product, U-4257 |
| Patent 11814359 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 11814359 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 12054465 | 001 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 12054465 | 002 | listed patent expiry date: 2035-01-21 | drug substance, U-4257 |
| Patent 9815805 | 001 | listed patent expiry date: 2035-01-21 | U-4257 |
| Patent 9815805 | 002 | listed patent expiry date: 2035-01-21 | U-4257 |
| Patent 9522894 | 001 | listed patent expiry date: 2035-03-12 | drug substance |
| Patent 9522894 | 002 | listed patent expiry date: 2035-03-12 | drug substance |
| Patent 12201638 | 001 | listed patent expiry date: 2039-03-01 | drug product |
| Patent 12201638 | 002 | listed patent expiry date: 2039-03-01 | drug product |
| Patent 12059424 | 001 | listed patent expiry date: 2040-02-21 | drug product |
| Patent 12059424 | 002 | listed patent expiry date: 2040-02-21 | drug product |
| Exclusivity NCE | 001 | listed exclusivity date: 2030-08-12 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2030-08-12 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- BRENSOCATIB · UNII 25CG88L0BB · lmmol compound AEXFXNFMSAAELR-RXVVDRJESA-N · CHEMBL3900409
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.