small molecule

APADAZ

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Loss of exclusivityFebruary 2031latest FDA-listed patent expiry
CompanyZEVRA THERAPEUTICS

Drug detail

Brand nameAPADAZ
Active ingredientACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Strength325MG;EQ 8.16MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJanuary 2019
Marketing statusDISCN

Listed patents

PatentExpiresType
8461137February 2031substance, product
9132125July 2030substance, product
8828978July 2030product
9549923July 2030substance, product
8748413July 2030substance, product

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.

APADAZ patent cliff — loss of exclusivity February 2031 | CliffBio