NDAORALTABLET
Approved
Jun 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
MONOKET (isosorbide mononitrate) by Alkermes is clinical pharmacology: isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (isdn), and most of the clinical activity of the dinitrate is attributable to the mononitrate. First approved in 1993.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Isosorbide mononitrate (MONOKET) is an oral nitrate vasodilator approved in 1993 for angina pectoris management. It relaxes vascular smooth muscle, reducing preload and afterload on the heart while dilating coronary arteries. The drug is the active metabolite of isosorbide dinitrate and requires a specific dosing regimen with nitrate-free intervals to prevent tolerance.
LOE Approaching
Product is in late lifecycle phase with declining exclusivity, indicating team restructuring and focus on cost management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY: Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle…
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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.