Register entry
- Registered sites
- 0
- Active NDC listings
- 3
- Live patents
- 42
- Exclusivities
- 2
- Countries
- 0
Catalogue
Drug listings by form and route
33 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.
| Dosage form | NDCs |
|---|---|
| tablet | 2 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 2 |
| respiratory (inhalation) | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| insmed incorporated | 3 |
Exclusivity
Patents and exclusivities
42| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8632804 | ARIKAYCE KITamikacin sulfate | use | Dec 2026 |
| 8642075 | ARIKAYCE KITamikacin sulfate | product | Dec 2026 |
| 8679532 | ARIKAYCE KITamikacin sulfate | use | Dec 2026 |
| 8226975 | ARIKAYCE KITamikacin sulfate | product | Aug 2028 |
| 9566234 | ARIKAYCE KITamikacin sulfate | product | Jan 2034 |
| 10287258 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 10669245 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 11655221 | BRINSUPRIbrensocatib | product | Jan 2035 |
| 11655222 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 11655223 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 11655224 | BRINSUPRIbrensocatib | product | Jan 2035 |
| 11673871 | BRINSUPRIbrensocatib | product | Jan 2035 |
| 11773069 | BRINSUPRIbrensocatib | product | Jan 2035 |
| 11814359 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 12054465 | BRINSUPRIbrensocatib | substance | Jan 2035 |
| 9815805 | BRINSUPRIbrensocatib | use | Jan 2035 |
| 9522894 | BRINSUPRIbrensocatib | substance | Mar 2035 |
| 10251900 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 10751355 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 11446318 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12016873 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12168021 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12168022 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12377114 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12616708 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 9895385 | ARIKAYCE KITamikacin sulfate | use | May 2035 |
| 12201638 | BRINSUPRIbrensocatib | product | Mar 2039 |
| 12059424 | BRINSUPRIbrensocatib | product | Feb 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| ARIKAYCE KITAMIKACIN SULFATE | GAIN Qualified infectious disease product (GAIN) | Sept 2030 |
| BRINSUPRIBRENSOCATIB | NCE New chemical entity | Aug 2030 |
Catalogue
Marketed products
3| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ARIKAYCE | Amikacin | suspension, respiratory (inhalation) | 71558-590NDA |
| Brinsupri | Brensocatib | tablet, oral | 71558-001NDA |
| Brinsupri | Brensocatib | tablet, oral | 71558-002NDA |
Enquiry
Common questions
- Is Insmed Incorporated FDA approved?
- Insmed Incorporated holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Insmed Incorporated make?
- 3 products are listed under Insmed Incorporated in the openFDA NDC Directory, most often as tablet; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.