CliffBio
small molecule

KOSELUGO

SELUMETINIB SULFATE

Loss of exclusivityNovember 2032FDA regulatory exclusivity expiry
CompanyASTRAZENECA PHARMACEUTICALS LP

Drug detail

Brand nameKOSELUGO
Active ingredientSELUMETINIB SULFATE
StrengthEQ 5MG BASE
Dosage formGRANULE
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2025
Marketing statusRX

Listed patents

PatentExpiresType
7425637March 2028substance
9562017December 2026substance
9156795December 2026substance, product
8178693March 2026substance, product

Regulatory exclusivity

CodeExpires
ODE*November 2032
NPPNovember 2028
NPSeptember 2028
ODE*April 2027

More from ASTRAZENECA PHARMACEUTICALS LP

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

KOSELUGO patent cliff — loss of exclusivity November 2032 | CliffBio