CliffBio
small molecule

NUCYNTA

TAPENTADOL HYDROCHLORIDE

Loss of exclusivityJanuary 2027FDA regulatory exclusivity expiry
CompanyCollegium Pharmaceutical →View the full company profile on CliffBio

Drug detail

Brand nameNUCYNTA
Active ingredientTAPENTADOL HYDROCHLORIDE
StrengthEQ 75MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2008
Marketing statusRX

Regulatory exclusivity

CodeExpires
PEDJanuary 2027
NPPJuly 2026

More from Collegium Pharmaceutical

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