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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
Drug Prices: :see details

Pharmacology for Tradename: ALINIA

Drug ClassAntiprotozoal
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► subscribeY ► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,968,961► subscribe ► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,965,590► 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
TABLET;ORAL021497-001Jul 21, 20045,387,598► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,578,621► subscribe
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 20025,859,038► 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
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen► subscribe
5,886,013 Antiviral composition► subscribe
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation► 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
Bulgaria103958► subscribe
Latvia12492► subscribe
Slovenia20149► 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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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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