← Patent-cliff monitor small molecule KALYDECO IVACAFTOR
Loss of exclusivity August 2033 latest FDA-listed patent expiry
Company VERTEX PHARMACEUTICALS INC
Drug detail Brand name KALYDECO Active ingredient IVACAFTOR Strength 25MG/PACKET Dosage form GRANULE Route ORAL Modality Small molecule FDA approval April 2019 Marketing status RX
Listed patents Patent Expires Type 8883206*PED August 2033 — 12214083*PED August 2033 — 11752106*PED August 2033 — 11147770*PED August 2033 — 10272046*PED August 2033 — 12214083 February 2033 product 11752106 February 2033 product 10272046 February 2033 product 11147770 February 2033 product 8883206 February 2033 product 10646481*PED February 2030 — 11564916*PED February 2030 — 12458635*PED February 2030 — 12458635 August 2029 product 11564916 August 2029 use U-3528 10646481 August 2029 product 8324242*PED February 2028 — 7495103*PED November 2027 — 8324242 August 2027 use U-2963 8410274*PED June 2027 — 9670163*PED June 2027 — 8754224*PED June 2027 — 7495103 May 2027 substance, product 8354427*PED January 2027 — 8410274 December 2026 product 8754224 December 2026 substance, product 9670163 December 2026 product 8354427 July 2026 use U-2964
Regulatory exclusivity Code Expires PED November 2028 PED June 2028 M-14 May 2028 ODE-338 December 2027 PED October 2026 ODE-236 April 2026
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.