← Patent-cliff monitor small molecule ARIKAYCE KIT AMIKACIN SULFATE
Loss of exclusivity May 2035 latest FDA-listed patent expiry
Company Insmed → View the full company profile on CliffBio Drug detail Brand name ARIKAYCE KIT Active ingredient AMIKACIN SULFATE Strength EQ 590MG BASE/8.4ML Dosage form SUSPENSION, LIPOSOMAL Route INHALATION Modality Small molecule FDA approval September 2018 Marketing status RX
Listed patents Patent Expires Type 12168021 May 2035 use U-2414 12168022 May 2035 use U-2414 12616708 May 2035 use U-2414 10251900 May 2035 use U-2414 12377114 May 2035 use U-2414 9895385 May 2035 use U-2417 12016873 May 2035 use U-2414 10751355 May 2035 use U-2414 11446318 May 2035 use U-2414 9566234 January 2034 product 8226975 August 2028 product 8642075 December 2026 product 8632804 December 2026 use U-2416 8679532 December 2026 use U-2415
Regulatory exclusivity Code Expires GAIN September 2030 ODE-214 September 2025
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.