NDAORALTABLET
Approved
Aug 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
6/8 — Strong
SYNJARDY (empagliflozin and metformin hydrochloride) by Boehringer Ingelheim is sodium-glucose transporter 2 inhibitors [moa]. Approved for sodium-glucose cotransporter 2 inhibitor [epc]. First approved in 2015.
Drug data last refreshed 13h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNJARDY is a fixed-dose oral combination tablet containing empagliflozin (SGLT2 inhibitor) and metformin hydrochloride, approved in 2015 for type 2 diabetes management. It works by inhibiting sodium-glucose cotransporter 2 to increase urinary glucose excretion while metformin reduces hepatic glucose production. The combination addresses multiple pathways in diabetes pathophysiology for improved glycemic control.
$164MPart D
PeakStable
8.3 years to LOEPeak lifecycle drug with stable $164M annual Part D spending indicates mature market with established commercial infrastructure and potential consolidation opportunities.
Mechanism of Action
Sodium-Glucose Transporter 2 Inhibitors
Pharmacologic Class:
Sodium-Glucose Cotransporter 2 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
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
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
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.