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Profile for Tradename: ALINIA

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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 five 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:5
Applicants:1
NDAs:2
Suppliers: see list2

Pharmacology for Tradename: ALINIA

Drug ClassAntiprotozoal

Clinical Trials for: ALINIA

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients
Status: Completed Condition: Hepatitis C

Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection
Status: Active, not recruiting Condition: HCV Coinfection; HIV Infection

The Effects of Nitazoxanide in Hepatic Encephalopathy
Status: Recruiting Condition: Hepatic Encephalopathy

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Status: Completed Condition: Influenza

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Status: Completed Condition: Chronic Hepatitis C

4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C
Status: Completed Condition: Chronic Hepatitis C

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Status: Completed Condition: Diarrhea

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
Status: Completed Condition: Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Status: Completed Condition: Influenza

Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects
Status: Completed Condition: HIV Infection; Hepatitis C Infection

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes5,578,621<disabled><disabled>
Romark
ALINIA
nitazoxanide
TABLET;ORAL021497-001Jul 21, 2004RXYes6,020,353<disabled>YY<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>
Romark
ALINIA
nitazoxanide
FOR SUSPENSION;ORAL021498-001Nov 22, 2002RXYes6,117,894<disabled><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
5,859,038 Method for treatment of helicobacter pylori infections<disabled in preview>
5,387,598 Composition and galenic formulation suitable for combatting affections of the lower abdomen<disabled in preview>
6,051,576 Means to achieve sustained release of synergistic drugs by conjugation<disabled in preview>
5,886,013 Antiviral composition<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 Publication Date
Eurasian Patent Organization002920Oct 31, 2002
Canada2418634Nov 12, 1998
Denmark0740650Sep 27, 2004
Japan4039683Jan 30, 2008
South Africa9803849Aug 27, 1999
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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