small molecule

XARTEMIS XR

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Loss of exclusivityMay 2032latest FDA-listed patent expiry
CompanyMALLINCKRODT INC

Drug detail

Brand nameXARTEMIS XR
Active ingredientACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2014
Marketing statusDISCN

Listed patents

PatentExpiresType
8658631May 2032product
8741885May 2032product
9468636May 2032use U-1499
9050335May 2032product
8992975May 2032product
8597681December 2030product
8980319December 2030product
8377453November 2029product
8372432March 2029product
8668929March 2029use U-1499
8394408March 2029product
7976870June 2027use U-1498

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.

XARTEMIS XR patent cliff — loss of exclusivity May 2032 | CliffBio