small molecule

OLPRUVA

SODIUM PHENYLBUTYRATE

Loss of exclusivityOctober 2036latest FDA-listed patent expiry
CompanyAcer, LlcView the full company profile on CliffBio

Drug detail

Brand nameOLPRUVA
Active ingredientSODIUM PHENYLBUTYRATE
Strength5GM/PACKET
Dosage formFOR SUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2022
Marketing statusRX

Listed patents

PatentExpiresType
11202767October 2036use U-3502
11154521October 2036product
11433041October 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.

OLPRUVA patent cliff — loss of exclusivity October 2036 | CliffBio