# BRINSUPRI — FDA application NDA217673

Informational only - not investment advice.

Application NDA217673 · type NDA · FDA status: approved · original approval 2025-08-12

Listed sponsor: INSMED INC · [INSM company profile](/company/INSM/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 10287258, product 001; listed patent expiry date: 2035-01-21.
- Patent 10287258, product 002; listed patent expiry date: 2035-01-21.
- Patent 10669245, product 001; listed patent expiry date: 2035-01-21.
- Patent 10669245, product 002; listed patent expiry date: 2035-01-21.
- Patent 11655221, product 001; listed patent expiry date: 2035-01-21.
- Patent 11655221, product 002; listed patent expiry date: 2035-01-21.
- Patent 11655222, product 001; listed patent expiry date: 2035-01-21.
- Patent 11655222, product 002; listed patent expiry date: 2035-01-21.
- Patent 11655223, product 001; listed patent expiry date: 2035-01-21.
- Patent 11655223, product 002; listed patent expiry date: 2035-01-21.
- Patent 11655224, product 001; listed patent expiry date: 2035-01-21.
- Patent 11655224, product 002; listed patent expiry date: 2035-01-21.
- Patent 11673871, product 001; listed patent expiry date: 2035-01-21.
- Patent 11673871, product 002; listed patent expiry date: 2035-01-21.
- Patent 11773069, product 001; listed patent expiry date: 2035-01-21.
- Patent 11773069, product 002; listed patent expiry date: 2035-01-21.
- Patent 11814359, product 001; listed patent expiry date: 2035-01-21.
- Patent 11814359, product 002; listed patent expiry date: 2035-01-21.
- Patent 12054465, product 001; listed patent expiry date: 2035-01-21.
- Patent 12054465, product 002; listed patent expiry date: 2035-01-21.
- Patent 9815805, product 001; listed patent expiry date: 2035-01-21.
- Patent 9815805, product 002; listed patent expiry date: 2035-01-21.
- Patent 9522894, product 001; listed patent expiry date: 2035-03-12.
- Patent 9522894, product 002; listed patent expiry date: 2035-03-12.
- Patent 12201638, product 001; listed patent expiry date: 2039-03-01.
- Patent 12201638, product 002; listed patent expiry date: 2039-03-01.
- Patent 12059424, product 001; listed patent expiry date: 2040-02-21.
- Patent 12059424, product 002; listed patent expiry date: 2040-02-21.
- Exclusivity NCE, product 001; listed exclusivity date: 2030-08-12.
- Exclusivity NCE, product 002; listed exclusivity date: 2030-08-12.

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](https://lmmol.com/compound/AEXFXNFMSAAELR-RXVVDRJESA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/INSM/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217673. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.