NDAORALFOR SUSPENSIONPriority Review
Approved
Nov 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
ALINIA (nitazoxanide) by Partner Therapeutics is 12. Approved for cryptosporidiosis. First approved in 2002.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is an oral antiprotozoal small molecule approved in 2002 for treatment of cryptosporidiosis and norovirus gastroenteritis. It is rapidly metabolized to active metabolite tizoxanide, which undergoes glucuronidation and is excreted primarily via feces and urine. The drug has expanded investigational use in COVID-19, hepatitis C, and severe acute respiratory illness.
LOE Approaching
Product approaches loss of exclusivity with modest competitive pressure (30%), indicating shrinking brand team and transition focus toward generic erosion management.
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.