NDAORALTABLETPriority Review
Approved
Oct 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
LONITEN (minoxidil) by Pfizer is clinical pharmacology 1. First approved in 1979.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LONITEN (minoxidil) is an oral small-molecule vasodilator originally approved for severe hypertension that has been repurposed for androgenetic alopecia treatment. It works by reducing peripheral vascular resistance and enhancing microcirculatory blood flow, mechanisms believed to stimulate hair follicle growth when applied topically or taken orally. The drug represents a classic off-label/reformulation success in dermatology.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30), indicating team downsizing and transition focus toward generic optimization and managed care contracting.
Mechanism of Action
CLINICAL PHARMACOLOGY 1. General Pharmacologic Properties Minoxidil is an orally effective direct acting peripheral vasodilator that reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. Microcirculatory blood flow in animals is enhanced or maintained…
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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.