NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
2
Data completeness
6/8 — Strong
JANUMET XR (sitagliptin and metformin hydrochloride) by Merck & Co. is 2 diabetes mellitus: sitagliptin, a dipeptidyl peptidase-4 (dpp-4) inhibitor, and metformin extended-release, a member of the biguanide class. First approved in 2012.
Drug data last refreshed 11h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JANUMET XR is a fixed-dose combination oral tablet containing sitagliptin (a DPP-4 inhibitor) and extended-release metformin (a biguanide) for type 2 diabetes management. It works through dual mechanism: sitagliptin increases incretin hormone activity to boost insulin secretion and reduce glucagon in a glucose-dependent manner, while metformin decreases hepatic glucose production and improves insulin sensitivity. The combination addresses multiple pathways of hyperglycemia in a single extended-release formulation.
$0.392BPart D
LOE Approaching10mo to LOEProduct is approaching loss of exclusivity (0.9 years remaining), signaling transition from growth investments to defensive strategies and potential team restructuring.
Mechanism of Action
2 diabetes mellitus: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin extended-release, a member of the biguanide class. Sitagliptin Sitagliptin is a DPP-4 inhibitor, which exerts its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones.…
Indications
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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.