← Patent-cliff monitor small molecule TAGRISSO OSIMERTINIB MESYLATE
Loss of exclusivity November 2042 latest FDA-listed patent expiry
Company ASTRAZENECA PHARMACEUTICALS LP
Drug detail Brand name TAGRISSO Active ingredient OSIMERTINIB MESYLATE Strength EQ 40MG BASE Dosage form TABLET Route ORAL Modality Small molecule FDA approval November 2015 Marketing status RX
Listed patents Patent Expires Type 12465608 November 2042 use U-3823 10183020 January 2035 product 8946235 August 2032 substance, product 9732058 July 2032 substance, product 11524951 July 2032 substance, product
Regulatory exclusivity Code Expires ODE-337 December 2027 I-952 September 2027 I-941 February 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.