← Patent-cliff monitor small molecule IMBRUVICA IBRUTINIB
Loss of exclusivity September 2036 latest FDA-listed patent expiry
Drug detail Brand name IMBRUVICA Active ingredient IBRUTINIB Strength 560MG Dosage form TABLET Route ORAL Modality Small molecule FDA approval February 2018 Marketing status DISCN
Listed patents Patent Expires Type 9655857*PED September 2036 — 10828259*PED September 2036 — 10010507*PED September 2036 — 10213386*PED September 2036 — 10010507 March 2036 product 10213386 March 2036 product 9655857 March 2036 product 10828259 March 2036 product 10695350*PED April 2035 — 9795604*PED April 2035 — 10463668*PED April 2035 — 10695350 October 2034 use U-2846 10463668 October 2034 use U-2654 9795604 October 2034 use U-2970 9296753*PED April 2034 — 10125140*PED December 2033 — 9725455*PED December 2033 — 10961251*PED December 2033 — 10106548*PED December 2033 — 9296753 October 2033 substance 9725455 June 2033 substance 10125140 June 2033 substance, product 10106548 June 2033 substance, product 10961251 June 2033 product 10478439*PED December 2031 — 8999999*PED December 2031 — 10751342*PED December 2031 — 9801881*PED December 2031 — 10653696*PED December 2031 — 10004746*PED December 2031 — 9125889*PED December 2031 — 9814721*PED December 2031 — 8754090*PED December 2031 — 10016435*PED December 2031 — 9801883*PED December 2031 — 9125889 June 2031 use U-1650 9801881 June 2031 use U-2242 8999999 June 2031 use U-2242 10004746 June 2031 use U-2242 10016435 June 2031 use U-1650 8754090 June 2031 use U-1456 9814721 June 2031 use U-1947 10478439 June 2031 use U-1684 9801883 June 2031 use U-2159 10653696 June 2031 use U-1456 10751342 June 2031 use U-1491 8008309*PED May 2028 — 8008309 November 2027 substance, product 8563563*PED October 2027 — 8497277*PED June 2027 — 8754091*PED June 2027 — 9181257*PED June 2027 — 8703780*PED June 2027 — 8957079*PED June 2027 — 8476284*PED June 2027 — 8735403*PED June 2027 — 7514444*PED June 2027 — 8952015*PED June 2027 — 8697711*PED June 2027 — 8563563 April 2027 use U-2242 8952015 December 2026 use U-2241 8697711 December 2026 substance, product 8957079 December 2026 substance, product 8735403 December 2026 substance, product 7514444 December 2026 substance, product 9181257 December 2026 substance 8754091 December 2026 product 8476284 December 2026 use U-2241 8497277 December 2026 use U-1456 8703780 December 2026 use U-2242
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.