small molecule

ZUBSOLV

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Loss of exclusivitySeptember 2032latest FDA-listed patent expiry
CompanyEDENBRIDGE PHARMACEUTICALS LLC DBA DEXCEL PHARMA USA

Drug detail

Brand nameZUBSOLV
Active ingredientBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
StrengthEQ 5.7MG BASE;EQ 1.4MG BASE
Dosage formTABLET
RouteSUBLINGUAL
ModalitySmall molecule
FDA approvalJuly 2013
Marketing statusRX

Listed patents

PatentExpiresType
9439900September 2032product
9259421September 2032product
10946010September 2032product
11020388September 2032product
11433066September 2032use U-3131
11020387September 2032product
8940330September 2032product
10874661September 2032product
8470361May 2030product
8658198December 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.

ZUBSOLV patent cliff — loss of exclusivity September 2032 | CliffBio