NDAORALTABLETPriority Review
Approved
Jul 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
ALINIA (nitazoxanide) by Partner Therapeutics is 12. First approved in 2004.
Drug data last refreshed 1h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is an oral antiprotozoal agent approved for treating parasitic infections in pediatric and adult patients. The drug is rapidly metabolized to its active form, tizoxanide, which undergoes glucuronidation for elimination. It demonstrates oral bioavailability enhanced by food co-administration and minimal plasma accumulation with repeated dosing.
LOE Approaching
As LOE approaches, the commercial team is consolidating with modest field presence; expect downsizing in sales infrastructure and shift toward maintenance-focused roles.
Mechanism of Action
12.1 Mechanism of Action Nitazoxanide is an antiprotozoal [ )]. 12.3 Pharmacokinetics Absorption Single Dosing : Following oral administration of ALINIA Tablets or Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameners of the metabolites,…
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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.