small molecule

OSMOLEX ER

AMANTADINE HYDROCHLORIDE

Loss of exclusivityFebruary 2038latest FDA-listed patent expiry
CompanySupernus PharmaceuticalsView the full company profile on CliffBio

Drug detail

Brand nameOSMOLEX ER
Active ingredientAMANTADINE HYDROCHLORIDE
StrengthEQ 258MG BASE
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2018
Marketing statusDISCN

Listed patents

PatentExpiresType
10213394February 2038use U-2497
10213393February 2038use U-20
10500170February 2038use U-20
10500172February 2038use U-2497
10500171February 2038use U-2497
10512617February 2038use U-2497
8252331March 2030product
8389578January 2028use U-3054

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.

OSMOLEX ER patent cliff — loss of exclusivity February 2038 | CliffBio