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Profile for Tradename: ALLEGRA

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Allegra is a drug marketed by Sanofi Aventis Us and is included in five NDAs. It is available from one supplier. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in ALLEGRA is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for Tradename: ALLEGRA

Patents:11
Applicants:1
NDAs:5
Suppliers / Packagers: see list2

Pharmacology for Tradename: ALLEGRA

Clinical Trials for: ALLEGRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYesRE39069<disabled>Y <disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-009Jan 24, 2011OTCYes5,932,247*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-009Jan 24, 2011OTCYes7,138,524*PED<disabled> <disabled>
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Expired Patents for Tradename: ALLEGRA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20067,138,524*PED<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19964,254,129<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20066,187,791<disabled>
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Paragraph IV activity for: ALLEGRA

Drugname Dosage Strength RLD Submissiondate
fexofenadine hydrochlorideOral Suspension30 mg/5 mLAllegra1/25/2010
fexofenadine hydrochloride and pseudoephedrine hydrochlorideExtended-release Tablets180 mg/240 mgAllegra-D 24 Hour6/6/2007

Non-Orange Book Patents for Tradename: ALLEGRA

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>
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: ALLEGRA

Country Document Number Publication Date
Norway307688May 15, 2000
Austria194913Aug 15, 2000
Germany69320952May 27, 1999
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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