small molecule

NUCYNTA

TAPENTADOL HYDROCHLORIDE

Loss of exclusivityJanuary 2027FDA regulatory exclusivity expiry
CompanyCollegium PharmaceuticalSee this company's full patent-cliff portfolio

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

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

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