NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
IRA Negotiated
SYNJARDY XR (empagliflozin, metformin hydrochloride) by Boehringer Ingelheim is sodium-glucose transporter 2 inhibitors [moa]. Approved for sodium-glucose cotransporter 2 inhibitor [epc]. First approved in 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNJARDY XR is a fixed-dose combination tablet containing empagliflozin (a sodium-glucose cotransporter 2 inhibitor) and metformin hydrochloride in extended-release formulation, approved by the FDA on December 9, 2016. It is indicated for the treatment of type 2 diabetes mellitus as an oral antidiabetic agent. The product combines two complementary mechanisms: empagliflozin increases urinary glucose excretion while metformin reduces hepatic glucose production and improves insulin sensitivity. SYNJARDY XR represents an extended-release convenience formulation of the original SYNJARDY combination, targeting patients requiring dual therapy with improved dosing convenience.
$0.3BPart D
8.6 years to LOEMechanism 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.
Why This Matters for Your Career
$278M Medicare spend — this is a commercially significant brand
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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.