← Patent-cliff monitor small molecule IMBRUVICA IBRUTINIB
Loss of exclusivity April 2035 latest FDA-listed patent expiry
Drug detail Brand name IMBRUVICA Active ingredient IBRUTINIB Strength 70MG Dosage form CAPSULE Route ORAL Modality Small molecule FDA approval December 2017 Marketing status RX
Listed patents Patent Expires Type 10463668*PED April 2035 — 10695350*PED April 2035 — 9795604*PED April 2035 — 10463668 October 2034 use U-2654 9795604 October 2034 use U-2969 10695350 October 2034 use U-2846 9296753*PED April 2034 — 9540382*PED February 2034 — 10294231*PED December 2033 — 9725455*PED December 2033 — 10106548*PED December 2033 — 9713617*PED December 2033 — 10125140*PED December 2033 — 10961251*PED December 2033 — 10294232*PED December 2033 — 9296753 October 2033 substance 9540382 August 2033 use U-1650 10106548 June 2033 substance, product 10961251 June 2033 product 9713617 June 2033 product 10294231 June 2033 product 9725455 June 2033 substance 10294232 June 2033 product 10125140 June 2033 substance, product 10004746*PED December 2031 — 9801883*PED December 2031 — 9125889*PED December 2031 — 10751342*PED December 2031 — 10478439*PED December 2031 — 9801881*PED December 2031 — 8999999*PED December 2031 — 10016435*PED December 2031 — 10004746 June 2031 use U-2241 9801881 June 2031 use U-1491 8999999 June 2031 use U-1946 9801883 June 2031 use U-2159 9125889 June 2031 use U-1650 10016435 June 2031 use U-1650 10478439 June 2031 use U-3422 11672803 June 2031 use U-1684 10751342 June 2031 use U-2943 8008309*PED May 2028 — 8008309 November 2027 substance, product 8563563*PED October 2027 — 8957079*PED June 2027 — 8735403*PED June 2027 — 9181257*PED June 2027 — 8703780*PED June 2027 — 8497277*PED June 2027 — 8476284*PED June 2027 — 8697711*PED June 2027 — 7514444*PED June 2027 — 8754091*PED June 2027 — 8952015*PED June 2027 — 8563563 April 2027 use U-1491 9181257 December 2026 substance 8957079 December 2026 substance, product 8754091 December 2026 product 7514444 December 2026 substance, product 8735403 December 2026 substance, product 8476284 December 2026 use U-1650 8703780 December 2026 use U-1491 8497277 December 2026 use U-3422 8952015 December 2026 use U-1491 8697711 December 2026 substance, product
Regulatory exclusivity Code Expires PED February 2030 ODE-405 August 2029 PED February 2026 NPP August 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.