small molecule

TASIGNA

NILOTINIB HYDROCHLORIDE

Loss of exclusivityOctober 2032latest FDA-listed patent expiry
CompanyNovartisView the full company profile on CliffBio

Drug detail

Brand nameTASIGNA
Active ingredientNILOTINIB HYDROCHLORIDE
StrengthEQ 50MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2018
Marketing statusRX

Listed patents

PatentExpiresType
9061029*PEDOctober 2032
9061029April 2032substance
8163904*PEDFebruary 2029
8163904August 2028substance, product
8293756*PEDMarch 2028
8293756September 2027product
8501760*PEDJanuary 2027
8415363*PEDJanuary 2027
8389537*PEDJanuary 2027
8389537July 2026use U-1374
8501760July 2026product
8415363July 2026substance, product

Regulatory exclusivity

CodeExpires
PEDMarch 2029
ODE-380September 2028

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.

TASIGNA patent cliff — loss of exclusivity October 2032 | CliffBio