small molecule

BELBUCA

BUPRENORPHINE HYDROCHLORIDE

Loss of exclusivityDecember 2032latest FDA-listed patent expiry
CompanyBioDelivery Sciences InternationalView the full company profile on CliffBio

Drug detail

Brand nameBELBUCA
Active ingredientBUPRENORPHINE HYDROCHLORIDE
StrengthEQ 0.3MG BASE
Dosage formFILM
RouteBUCCAL
ModalitySmall molecule
FDA approvalOctober 2015
Marketing statusRX

Listed patents

PatentExpiresType
9901539December 2032use U-1556
8147866July 2027product
9655843July 2027product

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.

BELBUCA patent cliff — loss of exclusivity December 2032 | CliffBio