small molecule

SYNJARDY XR

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Loss of exclusivityDecember 2034latest FDA-listed patent expiry
CompanyBoehringer IngelheimView the full company profile on CliffBio

Drug detail

Brand nameSYNJARDY XR
Active ingredientEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength25MG;1GM
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2016
Marketing statusRX

Listed patents

PatentExpiresType
9949998*PEDDecember 2034
9949997*PEDNovember 2034
10258637*PEDOctober 2034
12433906*PEDOctober 2034
11090323*PEDOctober 2034
11833166*PEDOctober 2034
9949998June 2034use U-2290
9949997May 2034use U-3533
10258637April 2034use U-2290
12433906April 2034use U-4296
11666590April 2034use U-4154
12263153April 2034use U-4154
12427162April 2034use U-4287
11833166April 2034use U-3776
11090323April 2034use U-3193
10596120*PEDSeptember 2032
10596120March 2032product
12115179*PEDAugust 2030
12115179February 2030use U-4023
7579449*PEDFebruary 2029
7579449August 2028substance
7713938*PEDOctober 2027
7713938April 2027substance, product

Regulatory exclusivity

CodeExpires
PEDDecember 2026
M-296June 2026

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.

SYNJARDY XR patent cliff — loss of exclusivity December 2034 | CliffBio