NDAORALTABLET2 Generics Approved
Approved
Sep 1977
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
10
Data completeness
4/8 — Partial
ATIVAN (lorazepam) by Bausch + Lomb. Approved for benzodiazepine [epc]. First approved in 1977.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATIVAN (lorazepam) is a benzodiazepine that acts as a central nervous system depressant with tranquilizing properties, used to treat epilepsy, status epilepticus, and anxiety disorders. It is rapidly absorbed and metabolized via glucuronidation with a mean half-life of approximately 12 hours. The drug shows no appreciable effects on respiratory or cardiovascular systems at clinical doses.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (45/100), signaling potential team consolidation and shift toward generic optimization or lifecycle extension strategies.
Mechanism of Action
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Started Nov 2014
26 enrolled
Status Epilepticus
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
Started Jan 2014
8 enrolled
Healthy
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
Started Dec 2013
31 enrolled
Healthy Volunteers
A Study of the Effect of LY2216684 on Lorazepam
Started Dec 2010
28 enrolled
Major Depressive Disorder
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Started Feb 2008
259 enrolled
Status Epilepticus
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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.