CliffBio
small molecule

KOSELUGO

SELUMETINIB SULFATE

Loss of exclusivityNovember 2032FDA regulatory exclusivity expiry
CompanyASTRAZENECA PHARMACEUTICALS LP

Drug detail

Brand nameKOSELUGO
Active ingredientSELUMETINIB SULFATE
StrengthEQ 10MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalApril 2020
Marketing statusRX

Listed patents

PatentExpiresType
12364684March 2029use U-4357
12220403March 2029product
11813246March 2029product
12318367March 2029product
7425637March 2028substance
9156795December 2026substance, product
9562017December 2026substance
8178693March 2026substance, product

Regulatory exclusivity

CodeExpires
ODE-545November 2032
NPPNovember 2028
NPPSeptember 2028
ODE-288April 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