AVANDAMET
LOE Approachingmetformin hydrochloride; rosiglitazone maleate
NDAORALTABLET
Approved
Oct 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
AVANDAMET (metformin hydrochloride; rosiglitazone maleate) is avandamet: avandamet combines 2 antidiabetic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: rosiglitazone, a member of the thiazolidinedione class, and metformin, a member of the biguanide class. Approved for type 2 diabetes mellitus, not already taking rosiglitazone, unable to achieve glycemic control on other diabetes medications and and 4 more indications. First approved in 2002.
Drug data last refreshed 5d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVANDAMET is a fixed-dose combination of rosiglitazone (thiazolidinedione) and metformin (biguanide) for oral treatment of type 2 diabetes mellitus. It combines two complementary mechanisms: rosiglitazone enhances insulin sensitivity via PPARγ activation in adipose tissue, muscle, and liver, while metformin decreases hepatic glucose production and improves peripheral glucose utilization. This dual-action approach is indicated for patients unable to achieve glycemic control on monotherapy or alternative diabetes agents.
LOE Approaching
Product is approaching loss of exclusivity, signaling potential team consolidation and shift from growth-focused to defensive commercial strategies.
Mechanism of Action
AVANDAMET: AVANDAMET combines 2 antidiabetic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: Rosiglitazone, a member of the thiazolidinedione class, and metformin, a member of the biguanide class. Thiazolidinediones are insulin sensitizing…
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.