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Profile for Tradename: CHILDREN\'S ALLEGRA HIVES

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Children\'s Allegra Hives is a drug marketed by Sanofi Aventis Us and is included in three NDAs. It is available from four suppliers. There are ten patents protecting this drug.

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

The generic ingredient in CHILDREN\'S ALLEGRA HIVES is fexofenadine hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for Tradename: CHILDREN\'S ALLEGRA HIVES

Patents:10
Applicants:1
NDAs:3
Suppliers / Packagers: see list27

Pharmacology for Tradename: CHILDREN\'S ALLEGRA HIVES

Clinical Trials for: CHILDREN\'S ALLEGRA HIVES

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 2011OTCYes8,933,097<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo7,138,524*PED<disabled><disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 2011OTCYes6,723,348<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo5,855,912*PED<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo7,135,571*PED<disabled><disabled>
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Non-Orange Book Patents for Tradename: CHILDREN\'S ALLEGRA HIVES

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
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
7,662,835Methods of treating allergic reactions using an anhydrous form of antihistaminic piperidine derivatives<disabled in preview>
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
7,666,881Methods of treating allergic reactions using hydrated forms of antihistaminic piperidine derivatives<disabled in preview>
8,129,408Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
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International Patent Family for Tradename: CHILDREN\'S ALLEGRA HIVES

Country Document Number Publication Date
Japan2010184938Aug 26, 2010
JapanH11501028Jan 26, 1999
World Intellectual Property Organization (WIPO)03041683Aug 28, 2003
World Intellectual Property Organization (WIPO)9323047Nov 25, 1993
Japan2008266347Nov 06, 2008
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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.

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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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