← Patent-cliff monitor small molecule KALYDECO IVACAFTOR
Loss of exclusivity February 2030 latest FDA-listed patent expiry
Company VERTEX PHARMACEUTICALS INC
Drug detail Brand name KALYDECO Active ingredient IVACAFTOR Strength 150MG Dosage form TABLET Route ORAL Modality Small molecule FDA approval January 2012 Marketing status RX
Listed patents Patent Expires Type 11564916*PED February 2030 — 12458635*PED February 2030 — 10646481*PED February 2030 — 12458635 August 2029 product 10646481 August 2029 product 11564916 August 2029 use U-3530 8324242*PED February 2028 — 7495103*PED November 2027 — 8324242 August 2027 use U-1906 9670163*PED June 2027 — 8410274*PED June 2027 — 8754224*PED June 2027 — 7495103 May 2027 substance, product 8354427*PED January 2027 — 8754224 December 2026 substance, product 8410274 December 2026 product 9670163 December 2026 product 8354427 July 2026 use U-1311
Regulatory exclusivity Code Expires PED June 2028 ODE-338 December 2027
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.