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Serving leading biopharmaceutical companies globally:

Accenture
Moodys
US Department of Justice
McKinsey
Cantor Fitzgerald
Citi
Farmers Insurance
AstraZeneca
Chubb
US Army

Generated: January 23, 2018

DrugPatentWatch Database Preview

NITAZOXANIDE - Generic Drug Details

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What are the generic drug sources for nitazoxanide and what is the scope of nitazoxanide patent protection?

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.

Nitazoxanide has one hundred and thirty-one patent family members in forty-two countries.

There are four drug master file entries for nitazoxanide. Three suppliers are listed for this compound.
Pharmacology for NITAZOXANIDE
Drug ClassAntiprotozoal

US Patents and Regulatory Information for NITAZOXANIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NITAZOXANIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ➤ Subscribe ➤ Subscribe
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Subscribe
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation ➤ Subscribe
5,886,013 Antiviral composition ➤ Subscribe
6,020,353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide ➤ Subscribe
5,578,621 Benzamide derivatives ➤ Subscribe
5,856,348 Method for treatment of trematodes with pharmaceutical compositions of tizoxanide and nitazoxanide ➤ Subscribe
5,859,038 Method for treatment of helicobacter pylori infections ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for NITAZOXANIDE

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Chubb
Cantor Fitzgerald
Queensland Health
Fish and Richardson
Johnson and Johnson
Novartis
Colorcon

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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