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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
UBS
Cipla
Express Scripts
Cerilliant
Argus Health
Merck
Medtronic
Harvard Business School

Generated: December 16, 2017

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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe► Subscribe
RomarkALINIAnitazoxanideTABLET;ORAL021497-001Jul 21, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nitazoxanide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideTABLET;ORAL021497-001Jul 21, 2004► Subscribe► Subscribe
RomarkALINIAnitazoxanideTABLET;ORAL021497-001Jul 21, 2004► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
RomarkALINIAnitazoxanideTABLET;ORAL021497-001Jul 21, 2004► Subscribe► Subscribe
RomarkALINIAnitazoxanideFOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
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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► Subscribe
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen► Subscribe
6,020,353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide► Subscribe
5,859,038 Method for treatment of helicobacter pylori infections► Subscribe
5,886,013 Antiviral composition► Subscribe
5,856,348 Method for treatment of trematodes with pharmaceutical compositions of tizoxanide and nitazoxanide► Subscribe
5,578,621 Benzamide derivatives► Subscribe
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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
Portugal1222921► Subscribe
Austria228839► Subscribe
JapanH09511997► Subscribe
Austria267798► Subscribe
Austria218557► Subscribe
Germany69809928► Subscribe
Argentina057242► Subscribe
China1158074► Subscribe
Austria281166► Subscribe
Argentina008355► Subscribe
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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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Federal Trade Commission
Express Scripts
Cantor Fitzgerald
US Army
Medtronic
Julphar
Queensland Health
Farmers Insurance

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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