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ALINIA Drug Profile

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

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

The generic ingredient in ALINIA is nitazoxanide. There are three drug master file entries for this compound. Two 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 list2

Pharmacology for Tradename: ALINIA

Drug ClassAntiprotozoal

Clinical Trials for: ALINIA

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20026,020,353<disabled>
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 20046,020,353<disabled>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,387,598<disabled>
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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<disabled in preview>
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen<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 Tradename: ALINIA

Country Document Number Estimated Expiration
New Zealand513881<disabled in preview>
Slovenia755386<disabled in preview>
Romania122247<disabled in preview>
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