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ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Drug Profile

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Allegra-d 24 Hour Allergy And Congestion is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug.

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

The generic ingredient in ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Clinical Trials for: ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYes6,613,357Dec 25, 2020Y
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYesRE39069May 29, 2018Y
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYes6,037,353*PEDSep 14, 2017Y
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Expired Patents for Tradename: ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20115,578,610*PED<disabled>
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20117,138,524*PED<disabled>
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20116,399,632*PED<disabled>
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Non-Orange Book Patents for Tradename: ALLEGRA-D 24 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
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
6,004,582 Multi-layered osmotic device<disabled in preview>
7,147,870Osmotic device containing pseudoephedrine and an H1 antagonist<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Country Document Number Estimated Expiration
Chile2004000304<disabled in preview>
Norway307688<disabled in preview>
China1158071<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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