NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
ZOFRAN (ondansetron hydrochloride) by Novartis is 5-ht 3 receptor antagonist. First approved in 1991.
Drug data last refreshed 11m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOFRAN (ondansetron hydrochloride) is a 5-HT3 receptor antagonist injectable medication used primarily for prevention and treatment of nausea and vomiting, particularly in oncology and post-operative settings. It works by blocking serotonin receptors in the chemoreceptor trigger zone and gastrointestinal tract, unlike dopamine antagonists. This mechanism makes it effective across multiple therapeutic contexts including chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV).
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30), brand teams face consolidation and transition toward generic defense or adjacent indication strategies.
Mechanism of Action
5-HT 3 receptor antagonist. While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
Started Oct 2006
26 enrolled
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
Started Oct 2006
26 enrolled
Healthy
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
Started Mar 2006
515 enrolled
Nausea and Vomiting, PostoperativePostoperative Nausea and Vomiting
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Started Mar 2006
482 enrolled
Nausea and Vomiting, Postoperative
Career Relevance
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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.