NDAORALFOR SUSPENSIONPriority Review
Approved
Nov 2002
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 2002.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALINIA (nitazoxanide) is an oral antiprotozoal agent approved in 2002 for parasitic infections. It is rapidly metabolized to tizoxanide, an active metabolite with enhanced bioavailability when taken with food. The drug is available as tablets and oral suspension, with the suspension formulation showing 70% relative bioavailability compared to tablets.
LOE Approaching
Product faces imminent loss of exclusivity with minimal commercial infrastructure; limited career growth opportunity in core commercial 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.