small molecule

NOXAFIL

POSACONAZOLE

Loss of exclusivityJanuary 2029FDA regulatory exclusivity expiry
CompanyMERCK SHARP AND DOHME CORP

Drug detail

Brand nameNOXAFIL
Active ingredientPOSACONAZOLE
Strength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET, DELAYED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2013
Marketing statusDISCN

Regulatory exclusivity

CodeExpires
NPPJanuary 2029
ODE-355June 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.

NOXAFIL patent cliff — loss of exclusivity January 2029 | CliffBio