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ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Drug Profile

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Allegra-d 12 Hour Allergy And Congestion is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug.

This drug has eighty-four patent family members in thirty-three countries.

The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION 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-D 12 HOUR ALLERGY AND CONGESTION

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Formulation / Manufacturing:see details

Pharmacology for Tradename: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Clinical Trials for: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

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 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,039,974<disabled>Y <disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes5,855,912*PED<disabled> <disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,113,942*PED<disabled> <disabled>
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Expired Patents for Tradename: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20117,138,524*PED<disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20116,399,632*PED<disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20115,578,610*PED<disabled>
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Non-Orange Book Patents for Tradename: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

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
5,738,872 Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
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>
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International Patent Family for Tradename: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Country Document Number Estimated Expiration
Mexico9302704<disabled in preview>
Poland337348<disabled in preview>
Slovakia283803<disabled in preview>
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