small molecule

TRINTELLIX

VORTIOXETINE HYDROBROMIDE

Loss of exclusivitySeptember 2032latest FDA-listed patent expiry
CompanyTAKEDA PHARMACEUTICALS USA INC

Drug detail

Brand nameTRINTELLIX
Active ingredientVORTIOXETINE HYDROBROMIDE
StrengthEQ 10MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2013
Marketing statusRX

Listed patents

PatentExpiresType
9278096*PEDSeptember 2032
9278096March 2032use U-2436
8722684*PEDDecember 2031
8722684June 2031substance, product
11458134*PEDDecember 2027
8969355*PEDDecember 2027
9227946*PEDDecember 2027
9125908*PEDDecember 2027
9125909*PEDDecember 2027
9125910*PEDDecember 2027
9861630*PEDDecember 2027
8969355June 2027use U-1668
9125910June 2027use U-2309
9861630June 2027use U-1668
9125908June 2027use U-2309
11458134June 2027product
9125909June 2027use U-2309
9227946June 2027use U-1668
7144884*PEDDecember 2026
7144884June 2026substance, product

Regulatory exclusivity

CodeExpires
PEDFebruary 2027
M-232August 2026

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.

TRINTELLIX patent cliff — loss of exclusivity September 2032 | CliffBio