small molecule

ACCUTANE

ISOTRETINOIN

Loss of exclusivityloss of exclusivity
CompanyHOFFMANN LA ROCHE INC

Drug detail

Brand nameACCUTANE
Active ingredientISOTRETINOIN
Strength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMay 1982
Marketing statusDISCN

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

ACCUTANE patent cliff — loss of exclusivity — | CliffBio