NDAINJECTIONINJECTABLE2 Generics Approved
Approved
Jul 1980
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
11
Data completeness
4/8 — Partial
ATIVAN (lorazepam) by Hikma. Approved for benzodiazepine [epc]. First approved in 1980.
Drug data last refreshed 11h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATIVAN (lorazepam) is a benzodiazepine approved in 1980 available as an injectable formulation used for acute anxiety, seizure management, and sedation in clinical settings. It works by enhancing GABA-mediated inhibition in the central nervous system to produce anxiolytic and sedative effects. The drug is administered via injection and remains a standard-of-care option in hospital and acute care environments.
LOE Approaching
As a 44-year-old injectable benzodiazepine approaching loss of exclusivity with moderate competitive pressure (60%), the brand team is likely consolidating to defend market position rather than expanding headcount.
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 (11)
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
Worked on ATIVAN at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.