NDAORALFOR SUSPENSIONPriority Review
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
17
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Tamiflu (oseltamivir phosphate) is an oral antiviral medication approved in 2000 for the treatment and prevention of influenza A and B in patients aged 2 weeks and older. It works by inhibiting viral neuraminidase, reducing viral shedding and shortening illness duration. The drug is available as an oral suspension formulation, making it accessible for pediatric and adult populations.
$0.004BPart D
LOE ApproachingDeclining
Product is in declining phase approaching loss of exclusivity, suggesting downsizing commercial teams and shift toward generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects
Started Aug 2023
18 enrolled
Drug Interaction
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
Started Mar 2012
16 enrolled
Healthy Volunteer
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
Started Jan 2011
65 enrolled
Influenza
A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
Started Jan 2011
9 enrolled
Influenza
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Started Dec 2010
8 enrolled
Influenza
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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.