NDAORALTABLET, EXTENDED RELEASE1 Generic Approved
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
23/100
Data completeness
3/8 — Basic
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIGDUO XR is a fixed-dose combination of dapagliflozin (SGLT2 inhibitor) and metformin hydrochloride (biguanide) in extended-release tablet form. It is indicated for type 2 diabetes mellitus to improve glycemic control in patients inadequately controlled on monotherapy or those already on both agents. The dual mechanism provides complementary glucose-lowering effects through renal glucose excretion and hepatic glucose production inhibition.
$199MPart D
Peak4.6 years to LOEAt peak commercial stage with $199M in annual Part D spending, XIGDUO XR supports a mature brand team managing market leadership in the fixed-dose combination diabetes segment.
Mechanism 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
LOE in ~5 years — strategic planning for patent cliff underway
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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.