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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Federal Trade Commission
Johnson and Johnson
Citi
Harvard Business School
AstraZeneca
Deloitte
Covington
Novartis
Fish and Richardson

Generated: July 24, 2017

DrugPatentWatch Database Preview

ALINIA Drug Profile

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What is the patent landscape for Alinia, and when can generic versions of Alinia launch?

Alinia is a drug marketed by Romark and is included in two NDAs. There are three patents protecting this drug.

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

The generic ingredient in ALINIA is nitazoxanide. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

Summary for Tradename: ALINIA

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list76
Clinical Trials: see list16
Patent Applications: see list1,001
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ALINIA at DailyMed

Pharmacology for Tradename: ALINIA

Drug ClassAntiprotozoal
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;ORAL021497-001Jul 21, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: ALINIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002► Subscribe► Subscribe
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 2004► Subscribe► Subscribe
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 2004► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: ALINIA

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
6,020,353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide► Subscribe
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen► Subscribe
5,856,348 Method for treatment of trematodes with pharmaceutical compositions of tizoxanide and nitazoxanide► Subscribe
5,886,013 Antiviral composition► Subscribe
5,859,038 Method for treatment of helicobacter pylori infections► 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 Tradename: ALINIA

Country Document Number Estimated Expiration
South Korea100426657► Subscribe
Eurasian Patent Organization200100956► Subscribe
Brazil9507371► Subscribe
Serbia50046► Subscribe
Czech Republic298269► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Colorcon
McKesson
Mallinckrodt
Cantor Fitzgerald
Johnson and Johnson
UBS
Dow
Cerilliant
Fish and Richardson

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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