small molecule

ZEJULA

NIRAPARIB TOSYLATE

Loss of exclusivityMarch 2038latest FDA-listed patent expiry
CompanyGlaxoSmithKlineView the full company profile on CliffBio

Drug detail

Brand nameZEJULA
Active ingredientNIRAPARIB TOSYLATE
StrengthEQ 100MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2017
Marketing statusDISCN

Listed patents

PatentExpiresType
11673877March 2038product
11091459March 2038product
8859562August 2031use U-2655
8071623March 2031substance, product
8436185April 2029substance
8143241August 2027use U-2655
8071579August 2027use U-2655

Regulatory exclusivity

CodeExpires
ODE-295April 2027
ODE-277October 2026

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.

ZEJULA patent cliff — loss of exclusivity March 2038 | CliffBio