NDAINJECTIONINJECTABLE2 Generics Approved
Approved
Jul 1980
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
10
Data completeness
5/8 — Partial
ATIVAN (lorazepam) by Hikma is clinical pharmacology studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Approved for epilepsy, status epilepticus, anxiety disorders and 1 more indications. First approved in 1980.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATIVAN (lorazepam) is a benzodiazepine administered by injection used to treat anxiety disorders, epilepsy, seizures, and status epilepticus. It works by enhancing central nervous system depression through GABAergic mechanisms, with rapid absorption and a half-life of approximately 12 hours. The drug is primarily metabolized via conjugation to lorazepam glucuronide, which is excreted renally.
LOE Approaching
ATIVAN is approaching loss of exclusivity with limited commercial momentum; expect smaller brand teams focused on defense and cost management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Lorazepam is readily absorbed with an absolute bioavailability of 90%. Peak…
Pharmacologic Class:
Benzodiazepine
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.