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Profile for Tradename: CHILDREN\'S ALLEGRA ALLERGY

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Children\'s Allegra Allergy 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 ALLERGY is fexofenadine hydrochloride. There are seventeen 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 ALLERGY

Patents:10
Applicants:1
NDAs:3
Suppliers / Packagers: see list26

Pharmacology for Tradename: CHILDREN\'S ALLEGRA ALLERGY

Clinical Trials for: CHILDREN\'S ALLEGRA ALLERGY

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 ALLERGY
fexofenadine hydrochloride
SUSPENSION;ORAL201373-001Jan 24, 2011OTCYes8,933,097<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-002Jan 24, 2011OTCYes5,738,872<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-002Jan 24, 2011OTCYes6,037,353<disabled><disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-005Jan 24, 2011OTCNo5,932,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-005Jan 24, 2011OTCNo7,138,524*PED<disabled><disabled>
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Non-Orange Book Patents for Tradename: CHILDREN\'S ALLEGRA ALLERGY

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

Country Document Number Publication Date
Hong Kong1069340Feb 02, 2007
Ukraine89584Feb 10, 2010
Japan5308824Oct 09, 2013
JapanH11501028Jan 26, 1999
Israel134771Feb 10, 2002
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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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