Details for New Drug Application (NDA): 217673
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NDA 217673 describes BRINSUPRI, which is a drug marketed by Insmed Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the BRINSUPRI profile page.
The generic ingredient in BRINSUPRI is brensocatib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brensocatib profile page.
The generic ingredient in BRINSUPRI is brensocatib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brensocatib profile page.
Summary for 217673
| Tradename: | BRINSUPRI |
| Applicant: | Insmed Inc |
| Ingredient: | brensocatib |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217673
Generic Entry Date for 217673*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 217673
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRINSUPRI | brensocatib | TABLET;ORAL | 217673 | NDA | Insmed Incorporated | 71558-001 | 71558-001-30 | 30 TABLET in 1 BOTTLE (71558-001-30) |
| BRINSUPRI | brensocatib | TABLET;ORAL | 217673 | NDA | Insmed Incorporated | 71558-002 | 71558-002-30 | 30 TABLET in 1 BOTTLE (71558-002-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 12, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 12, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,287,258 | Patent Expiration: | Jan 21, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF NON-CYSTIC FIBROSIS BRONCHIECTASIS IN PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,669,245 | Patent Expiration: | Jan 21, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF NON-CYSTIC FIBROSIS BRONCHIECTASIS IN PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
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