NDAORALTABLET, EXTENDED RELEASE1 Generic Approved
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
15/100
Data completeness
3/8 — Basic
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIGDUO XR is a fixed-dose combination tablet containing dapagliflozin (an SGLT2 inhibitor) and metformin hydrochloride (a biguanide) in extended-release formulation, approved by the FDA on October 29, 2014. It is indicated for the treatment of Type 2 Diabetes Mellitus as an oral therapy. The combination leverages two complementary mechanisms: metformin reduces hepatic glucose production and improves insulin sensitivity, while dapagliflozin increases urinary glucose excretion. XIGDUO XR is positioned as a dual-mechanism agent for patients requiring intensified glycemic control beyond monotherapy.
$0.2BPart D
5.0 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
$199M 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.