small molecule

ORTIKOS

BUDESONIDE

Loss of exclusivitySeptember 2036latest FDA-listed patent expiry
CompanySUN PHARMACEUTICAL INDUSTRIES INC

Drug detail

Brand nameORTIKOS
Active ingredientBUDESONIDE
Strength9MG
Dosage formCAPSULE, DELAYED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalJune 2019
Marketing statusDISCN

Listed patents

PatentExpiresType
10172802September 2036use U-2554
9707182September 2036product

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.

ORTIKOS patent cliff — loss of exclusivity September 2036 | CliffBio