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ALLEGRA Drug Profile

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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 nine patents protecting this drug and two Paragraph IV challenges.

This drug has forty-nine patent family members in twenty-three countries.

The generic ingredient in ALLEGRA is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Sixteen 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:9
Applicants:1
NDAs:5
Suppliers / Packagers: see list1

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-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYes6,037,353*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 1996DISCNNo6,113,942*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
CAPSULE;ORAL020625-001Jul 25, 19965,578,610*PED<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19965,932,247*PED<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 19965,738,872*PED<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
8,129,408Pharmaceutical composition for piperidinoalkanol compounds<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>
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International Patent Family for Tradename: ALLEGRA

Country Document Number Estimated Expiration
Germany69624559<disabled in preview>
South Korea100405116<disabled in preview>
Denmark0639976<disabled in preview>
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