NDAORALTABLET
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
DORAL (quazepam) by Galt Pharmaceuticals is tablet, like other central nervous system agents of the 14-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (cns). Approved for insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings and 1 more indications. First approved in 1985.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DORAL (quazepam) is an oral benzodiazepine tablet approved in 1985 for insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and early morning awakenings. It works by binding to stereo-specific receptors in the central nervous system, though the exact mechanism of action remains unknown. This is a legacy small-molecule CNS agent with declining market relevance.
LOE Approaching1.8 years to LOE
Product faces patent expiry in 1.9 years (June 2028), signaling imminent generic competition and likely team contraction; sales and marketing roles focus on maximizing remaining exclusivity window.
Mechanism of Action
Tablet, like other central nervous system agents of the 14-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown.
Pharmacologic Class:
Benzodiazepine
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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.