← Patent-cliff monitor small molecule ORKAMBI IVACAFTOR; LUMACAFTOR
Loss of exclusivity June 2031 latest FDA-listed patent expiry
Company VERTEX PHARMACEUTICALS INC
Drug detail Brand name ORKAMBI Active ingredient IVACAFTOR; LUMACAFTOR Strength 94MG/PACKET;75MG/PACKET Dosage form GRANULE Route ORAL Modality Small molecule FDA approval September 2022 Marketing status RX
Listed patents Patent Expires Type 8993600*PED June 2031 — 8507534*PED March 2031 — 8716338*PED March 2031 — 8993600 December 2030 product 8507534 September 2030 substance, product 8716338 September 2030 product 9192606*PED March 2030 — 11564916*PED February 2030 — 12458635*PED February 2030 — 10646481*PED February 2030 — 8846718*PED January 2030 — 9192606 September 2029 product 10646481 August 2029 product 12458635 August 2029 product 11564916 August 2029 use U-3526 8846718 July 2029 use U-3427 12065432*PED June 2029 — 9150552*PED June 2029 — 8653103*PED June 2029 — 10597384*PED June 2029 — 10597384 December 2028 substance, product 12065432 December 2028 use U-3983 9150552 December 2028 use U-3427 8653103 December 2028 product 8324242*PED February 2028 — 7495103*PED November 2027 — 8324242 August 2027 use U-3424 8410274*PED June 2027 — 9931334*PED June 2027 — 8754224*PED June 2027 — 9670163*PED June 2027 — 7495103 May 2027 substance, product 7973038*PED May 2027 — 9216969*PED May 2027 — 8741933*PED May 2027 — 9931334 December 2026 product 9670163 December 2026 product 8754224 December 2026 substance, product 8410274 December 2026 product 7973038 November 2026 use U-3424 9216969 November 2026 product 8741933 November 2026 use U-3424
Regulatory exclusivity Code Expires PED March 2030 ODE-408 September 2029 PED June 2028 M-14 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.