FDA Orange Book
Is there a generic for Brinsupri?
Brinsupri contains brensocatib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brinsupri (brensocatib). The Orange Book shows its last listed patent expires February 21, 2040 and its last listed exclusivity ends August 12, 2030.
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Brinsupri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
NDA 217673, held by INSMED INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Brinsupri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12054465 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 11814359 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 11773069 | January 21, 2035 | Drug product | U-4257 | 217673 |
| 11673871 | January 21, 2035 | Drug product | U-4257 | 217673 |
| 11655224 | January 21, 2035 | Drug product | U-4257 | 217673 |
| 11655223 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 11655222 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 11655221 | January 21, 2035 | Drug product | U-4257 | 217673 |
| 10669245 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 10287258 | January 21, 2035 | Drug substance | U-4257 | 217673 |
| 9815805 | January 21, 2035 | Method of use | U-4257 | 217673 |
| 9522894 | March 12, 2035 | Drug substance | None | 217673 |
| 12201638 | March 1, 2039 | Drug product | None | 217673 |
| 12059424 | February 21, 2040 | Drug product | None | 217673 |
Brinsupri exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 12, 2030 | 217673 |
Brinsupri NDC codes
Questions
Is there a generic for Brinsupri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brinsupri (brensocatib). The Orange Book shows its last listed patent expires February 21, 2040 and its last listed exclusivity ends August 12, 2030.
What is the generic name for Brinsupri?
The active ingredient in Brinsupri is brensocatib, per the FDA Orange Book.
When does the Brinsupri patent expire?
The last patent listed for Brinsupri in the Orange Book expires February 21, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.