NDAORALCAPSULE, EXTENDED RELEASE
Approved
Sep 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
DILATRATE-SR (isosorbide dinitrate) by Thayer Medical is clinical pharmacology the principal pharmacological action of isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. First approved in 1988.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DILATRATE-SR is an extended-release oral capsule containing isosorbide dinitrate, an organic nitrate that relaxes vascular smooth muscle to dilate peripheral arteries and veins. It is indicated for heart failure and diabetes management by reducing cardiac preload and afterload while improving coronary blood flow. The drug's mechanism requires nitrate-free intervals to prevent tolerance development.
LOE Approaching
Product approaching loss of exclusivity with minimal linked job openings indicates a mature, stable team likely focused on lifecycle extension and generic transition management.
Mechanism of Action
Clinical Pharmacology The principal pharmacological action of isosorbide dinitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to…
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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.