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 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is an oral antiprotozoal agent indicated for parasitic and protozoal infections. It works by disrupting metabolic pathways in target organisms through its active metabolite, tizoxanide. The drug is rapidly metabolized via hydrolysis and glucuronidation, with excretion primarily through feces and urine.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30%), indicating team consolidation and transition planning underway.
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.