SYNJARDY

Peak

empagliflozin and metformin hydrochloride

NDAORALTABLET
Approved
Aug 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4

Mechanism of Action

Sodium-Glucose Transporter 2 Inhibitors

Pharmacologic Class:

Sodium-Glucose Cotransporter 2 Inhibitor

Clinical Trials (4)

NCT06823856Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started May 2025
64 enrolled
Diabetes Mellitus Type 2
NCT06792968Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started Mar 2025
64 enrolled
Diabetes Mellitus Type 2
NCT06766500Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started Jan 2025
64 enrolled
Diabetes Mellitus Type 2
NCT05132023Phase 1Completed

Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

Started Mar 2019
26 enrolled
Healthy

Loss of Exclusivity

LOE Date
Nov 17, 2034
105 months away
Patent Expiry
Nov 17, 2034
Exclusivity Expiry
Dec 20, 2026

Patent Records (5)

Patent #ExpiryTypeUse Code
7713938
Apr 15, 2027
SubstanceProduct
7713938*PED
Oct 15, 2027
7579449
Aug 1, 2028
Substance
7579449*PED
Feb 1, 2029
12115179
Feb 11, 2030
U-4023