small molecule

OSMOLEX ER

AMANTADINE HYDROCHLORIDE

Loss of exclusivityFebruary 2038latest FDA-listed patent expiry
CompanySupernus PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameOSMOLEX ER
Active ingredientAMANTADINE HYDROCHLORIDE
StrengthEQ 193MG BASE
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2018
Marketing statusDISCN

Listed patents

PatentExpiresType
10213394February 2038use U-2497
10500172February 2038use U-2497
10500170February 2038use U-20
10500171February 2038use U-2497
10512617February 2038use U-2497
11890261February 2038use U-2497
10213393February 2038use U-20
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