small molecule

ONAPGO

APOMORPHINE HYDROCHLORIDE

Loss of exclusivityFebruary 2028FDA regulatory exclusivity expiry
CompanyMDD US OPERATIONS LLC A SUB OF SUPERNUS PHARMACEUTICALS INC

Drug detail

Brand nameONAPGO
Active ingredientAPOMORPHINE HYDROCHLORIDE
Strength98MG/20ML (4.9MG/ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalFebruary 2025
Marketing statusRX

Regulatory exclusivity

CodeExpires
NPFebruary 2028

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

ONAPGO patent cliff — loss of exclusivity February 2028 | CliffBio