CliffBio
small molecule

KOMBIGLYZE XR

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Loss of exclusivityOctober 2027FDA regulatory exclusivity expiry
CompanyASTRAZENECA AB

Drug detail

Brand nameKOMBIGLYZE XR
Active ingredientMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Strength500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2010
Marketing statusDISCN

Regulatory exclusivity

CodeExpires
M-14October 2027

More from ASTRAZENECA AB

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

KOMBIGLYZE XR patent cliff — loss of exclusivity October 2027 | CliffBio