small molecule

NUCYNTA

TAPENTADOL HYDROCHLORIDE

Loss of exclusivityJanuary 2027FDA regulatory exclusivity expiry
CompanyCollegium PharmaceuticalView the full company profile on CliffBio

Drug detail

Brand nameNUCYNTA
Active ingredientTAPENTADOL HYDROCHLORIDE
StrengthEQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formSOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2012
Marketing statusDISCN

Regulatory exclusivity

CodeExpires
PEDJanuary 2027
NPPJuly 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

NUCYNTA patent cliff — loss of exclusivity January 2027 | CliffBio