# ARIKAYCE KIT — FDA application NDA207356

Informational only - not investment advice.

Application NDA207356 · type NDA · FDA status: approved · original approval 2018-09-28

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 | ARIKAYCE KIT | AMIKACIN SULFATE | SUSPENSION, LIPOSOMAL | INHALATION | EQ 590MG BASE/8.4ML | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8632804, product 001; listed patent expiry date: 2026-12-05.
- Patent 8642075, product 001; listed patent expiry date: 2026-12-05.
- Patent 8679532, product 001; listed patent expiry date: 2026-12-05.
- Patent 8226975, product 001; listed patent expiry date: 2028-08-15.
- Patent 9566234, product 001; listed patent expiry date: 2034-01-18.
- Patent 10251900, product 001; listed patent expiry date: 2035-05-15.
- Patent 10751355, product 001; listed patent expiry date: 2035-05-15.
- Patent 11446318, product 001; listed patent expiry date: 2035-05-15.
- Patent 12016873, product 001; listed patent expiry date: 2035-05-15.
- Patent 12168021, product 001; listed patent expiry date: 2035-05-15.
- Patent 12168022, product 001; listed patent expiry date: 2035-05-15.
- Patent 12377114, product 001; listed patent expiry date: 2035-05-15.
- Patent 12616708, product 001; listed patent expiry date: 2035-05-15.
- Patent 9895385, product 001; listed patent expiry date: 2035-05-15.
- Exclusivity ODE-214, product 001; listed exclusivity date: 2025-09-28.
- Exclusivity GAIN, product 001; listed exclusivity date: 2030-09-28.

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

- AMIKACIN · UNII 84319SGC3C · no lmmol compound match

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:NDA207356. FDA data retrieved 2026-08-07.

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