small molecule

SPRYCEL

DASATINIB

Loss of exclusivitySeptember 2026latest FDA-listed patent expiry
CompanyBRISTOL MYERS SQUIBB CO

Drug detail

Brand nameSPRYCEL
Active ingredientDASATINIB
Strength140MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2010
Marketing statusRX

Listed patents

PatentExpiresType
7491725*PEDSeptember 2026
7491725March 2026substance, product

Regulatory exclusivity

CodeExpires
PEDJune 2026
ODE-225December 2025

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.

SPRYCEL patent cliff — loss of exclusivity September 2026 | CliffBio