small molecule

TASIGNA

NILOTINIB HYDROCHLORIDE

Loss of exclusivityOctober 2032latest FDA-listed patent expiry
CompanyNovartisSee this company's full patent-cliff portfolio

Drug detail

Brand nameTASIGNA
Active ingredientNILOTINIB HYDROCHLORIDE
StrengthEQ 150MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalJune 2010
Marketing statusRX

Listed patents

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

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