CliffBio
small molecule

OTREXUP

METHOTREXATE

Loss of exclusivityMay 2031latest FDA-listed patent expiry
CompanyASSERTIO SPECIALTY PHARMACEUTICALS LLC

Drug detail

Brand nameOTREXUP
Active ingredientMETHOTREXATE
Strength7.5MG/0.4ML (7.5MG/0.4ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalNovember 2014
Marketing statusDISCN

Listed patents

PatentExpiresType
8814834May 2031product
8579865March 2030product
12357642March 2030product
11497753March 2030product
8945063March 2030product
9421333March 2030product
8480631March 2030product
10709844March 2029product
11684723March 2029product
9867949March 2029product
8021335October 2026product
9533102January 2026product
9629959January 2026product
8562564January 2026product
11446441January 2026product

More from ASSERTIO SPECIALTY PHARMACEUTICALS LLC

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.

OTREXUP patent cliff — loss of exclusivity May 2031 | CliffBio