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 5MG 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—
9125908June 2027use U-2309
9861630June 2027use U-1668
9227946June 2027use U-1668
11458134June 2027product
9125909June 2027use U-2309
8969355June 2027use U-1668
9125910June 2027use U-2309
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.