TRANDATE
LOE ApproachingNDAORALTABLET
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
TRANDATE by Alvogen is clinical pharmacology labetalol hcl combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. Approved for the management of hypertension. First approved in 1984.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRANDATE is an oral tablet small-molecule antihypertensive agent approved in 1984 for blood pressure management. The generic name and mechanism of action are not specified in available data, but it represents a mature, established therapeutic option in cardiovascular care. It is administered orally as a tablet formulation.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting a consolidation-phase team focused on cost management and generic transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following…
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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.