small molecule

TAGRISSO

OSIMERTINIB MESYLATE

Loss of exclusivityNovember 2042latest FDA-listed patent expiry
CompanyASTRAZENECA PHARMACEUTICALS LP

Drug detail

Brand nameTAGRISSO
Active ingredientOSIMERTINIB MESYLATE
StrengthEQ 80MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2015
Marketing statusRX

Listed patents

PatentExpiresType
12465608November 2042use U-3823
10183020January 2035product
8946235August 2032substance, product
9732058July 2032substance, product
11524951July 2032substance, product

Regulatory exclusivity

CodeExpires
ODE-337December 2027
I-952September 2027
I-941February 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.