grepcent public filings, reorganized for comparison

ARIKAYCE KIT — FDA application NDA207356

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

Listed sponsor: INSMED INC · INSM company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001ARIKAYCE KITAMIKACIN SULFATESUSPENSION, LIPOSOMALINHALATIONEQ 590MG BASE/8.4MLPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 8632804001listed patent expiry date: 2026-12-05U-2416
Patent 8642075001listed patent expiry date: 2026-12-05drug product
Patent 8679532001listed patent expiry date: 2026-12-05U-2415
Patent 8226975001listed patent expiry date: 2028-08-15drug product
Patent 9566234001listed patent expiry date: 2034-01-18drug product, U-2415
Patent 10251900001listed patent expiry date: 2035-05-15U-2414
Patent 10751355001listed patent expiry date: 2035-05-15U-2414
Patent 11446318001listed patent expiry date: 2035-05-15U-2414
Patent 12016873001listed patent expiry date: 2035-05-15U-2414
Patent 12168021001listed patent expiry date: 2035-05-15U-2414
Patent 12168022001listed patent expiry date: 2035-05-15U-2414
Patent 12377114001listed patent expiry date: 2035-05-15U-2414
Patent 12616708001listed patent expiry date: 2035-05-15U-2414
Patent 9895385001listed patent expiry date: 2035-05-15U-2417
Exclusivity ODE-214001listed exclusivity date: 2025-09-28FDA code as listed
Exclusivity GAIN001listed exclusivity date: 2030-09-28FDA code as listed
NDA207356 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207356 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207356 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002018-09-281.002025-09-281.002026-12-051.002028-08-151.002030-09-281.002034-01-181.002035-05-151.00

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

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

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

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