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StrengthEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2013
Marketing statusDISCN

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
9125910June 2027use U-2309
9125909June 2027use U-2309
9125908June 2027use U-2309
8969355June 2027use U-1668
9227946June 2027use U-1668
11458134June 2027product
9861630June 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