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Details for Generic Name: nitazoxanide

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Nitazoxanide is the generic ingredient in one branded drug marketed by Romark and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for nitazoxanide. Two suppliers are listed for this compound.

Summary for Generic Name: nitazoxanide

Drug Master File Entries: see list3
Suppliers: see list2
Therapeutic Class:Antiparasitics

Pharmacology for Ingredient: nitazoxanide

Drug ClassAntiprotozoal

Clinical Trials for: nitazoxanide

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Status: Completed Condition: Hepatitis C

The Effects of Nitazoxanide in Hepatic Encephalopathy
Status: Recruiting Condition: Hepatic Encephalopathy

Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection
Status: Active, not recruiting Condition: HCV Coinfection; HIV Infection

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Status: Completed Condition: Influenza

Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects
Status: Completed Condition: HIV Infection; Hepatitis C Infection

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Status: Completed Condition: Chronic Hepatitis C

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Status: Completed Condition: Diarrhea

4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Status: Completed Condition: Chronic Hepatitis C

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Status: Completed Condition: Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus

A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures
Status: Completed Condition: Hepatitis C Infection; HIV Infection

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
FOR SUSPENSION;ORAL021498Nov 22, 2002RXYes6,020,353<disabled><disabled>
TABLET;ORAL021497Jul 21, 2004RXYes5,578,621<disabled>Y<disabled>
FOR SUSPENSION;ORAL021498Nov 22, 2002RXYes5,578,621<disabled><disabled>
TABLET;ORAL021497Jul 21, 2004RXYes5,968,961<disabled>Y<disabled>
FOR SUSPENSION;ORAL021498Nov 22, 2002RXYes6,117,894<disabled><disabled>
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Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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