NDAORALTABLETPriority Review
Approved
Jun 2005
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 2005.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is a small-molecule antiprotozoal agent approved for treating parasitic and protozoal infections. The drug is rapidly metabolized to its active form, tizoxanide, which undergoes glucuronidation and is eliminated via urine, bile, and feces. It is administered orally with food to optimize bioavailability.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30/100), indicating a consolidation phase and potential team restructuring.
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.