CliffBio
small molecule

XIGDUO XR

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Loss of exclusivityMay 2031latest FDA-listed patent expiry
CompanyASTRAZENECA AB

Drug detail

Brand nameXIGDUO XR
Active ingredientDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength10MG;500MG
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2014
Marketing statusRX

Listed patents

PatentExpiresType
9616028*PEDMay 2031—
8685934*PEDNovember 2030—
9616028November 2030product
7919598*PEDJune 2030—
8685934May 2030use U-1522
7919598December 2029substance
8501698*PEDDecember 2027—
8501698June 2027product
6515117*PEDApril 2026—
6515117October 2025substance, product

Regulatory exclusivity

CodeExpires
PEDDecember 2027
NPPJune 2027

More from ASTRAZENECA AB

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.

XIGDUO XR patent cliff — loss of exclusivity May 2031 | CliffBio