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Nitazoxanide - Generic Drug Details

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Nitazoxanide is the generic ingredient in one branded drug marketed by Romark and is included in two NDAs. There are three 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:3
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packaging: see list2
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Drug Prices:see low prices

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, 2002RXYes5,965,590Jul 3, 2017
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,968,961May 7, 2017
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes6,117,894May 7, 2017
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Expired Orange Book Patents for Generic Ingredient: nitazoxanide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,387,598<disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,856,348<disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,578,621<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
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation<disabled in preview>
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen<disabled in preview>
5,859,038 Method for treatment of helicobacter pylori infections<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: nitazoxanide

Country Document Number Estimated Expiration
Israel132516<disabled in preview>
Romania118293<disabled in preview>
New Zealand513881<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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