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 11h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is an oral antiprotozoal agent approved in 2004 for treating parasitic infections. The drug works by disrupting metabolic pathways essential to protozoan survival. It is rapidly metabolized to an active metabolite, tizoxanide, which undergoes glucuronidation and is excreted via multiple routes.
LOE Approaching
Product is in late-stage lifecycle with limited commercial expansion; small team size (3 linked jobs) suggests focused, specialized staffing model focused on managed decline and niche market maintenance.
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.