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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.

This ingredient has one hundred and twenty-one patent family members in forty-two countries.

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

Summary for Generic Name: nitazoxanide

Tradenames:1
Patents:5
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packaging: see list5
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nitazoxanide

Drug ClassAntiprotozoal

Clinical Trials for: nitazoxanide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes6,117,894<disabled><disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,965,590<disabled><disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,968,961<disabled><disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,578,621<disabled><disabled>
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 2004RXYes5,968,961<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: nitazoxanide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen<disabled in preview>
5,886,013 Antiviral composition<disabled in preview>
5,859,038 Method for treatment of helicobacter pylori infections<disabled in preview>
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation<disabled in preview>
5,856,348 Method for treatment of trematodes with pharmaceutical compositions of tizoxanide and nitazoxanide<disabled in preview>
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International Patent Family for Ingredient: nitazoxanide

Country Document Number Publication Date
Bulgaria62932Nov 30, 2000
Czech Republic298269Aug 08, 2007
Australia740022Oct 25, 2001
Japan2001503067Mar 06, 2001
Latvia12492Jan 20, 2001
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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