small molecule

CALDOLOR

IBUPROFEN

Loss of exclusivityMay 2026FDA regulatory exclusivity expiry
CompanyCumberlandSee this company's full patent-cliff portfolio

Drug detail

Brand nameCALDOLOR
Active ingredientIBUPROFEN
Strength400MG/4ML (100MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalJune 2009
Marketing statusDISCN

Regulatory exclusivity

CodeExpires
NPPMay 2026

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

CALDOLOR patent cliff — loss of exclusivity May 2026 | CliffBio