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 7h 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 treating parasitic infections. The drug is rapidly metabolized to its active form, tizoxanide, which undergoes glucuronidation before excretion. It is available as tablets and oral suspension formulations requiring food administration for optimal bioavailability.
LOE Approaching
Product approaching loss of exclusivity signals transition from growth-phase team expansion to defensive positioning and generic preparation strategies.
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.