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Details for Patent: 7,138,524

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Patent 7,138,524 protects ALLEGRA, CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES, ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, ALLEGRA ALLERGY, and ALLEGRA HIVES, and is included in six NDAs. There has been one Paragraph IV challenge on Allegra. There are five tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for ALLEGRA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-one patent family members in nineteen countries.

Summary for Patent: 7,138,524

Title:Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof
Abstract:The present invention is related to novel processes for preparing anhydrous and hydrated forms of piperidine derivatives, polymorphs and pseudomorphs thereof of the formulas ##STR00001## which are useful as antihistamines, antiallergic agents and bronchodilators.
Inventor(s): McCarty; Frederick J. (Hilton Head Island, SC), Carr; Albert A. (Cincinnati, OH)
Assignee: Aventis Pharmaceuticals, Inc. (Bridgewater, NJ)
Application Number:10/162,011
Patent Claim Types:
see list of patent claims
Compound;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
CAPSULE;ORAL020625-001Jul 25, 1996DISCNNo7,138,524*PED<disabled>
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 2006RXYes7,138,524*PED<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
SUSPENSION;ORAL201373-001Jan 24, 2011OTCYes7,138,524*PED<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 2011OTCYes7,138,524*PED<disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes7,138,524*PED<disabled>
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Non-Orange Book Patents for Patent: 7,138,524

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
7,666,881Methods of treating allergic reactions using hydrated forms of antihistaminic piperidine derivatives<disabled in preview>
7,135,571Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof<disabled in preview>
7,662,835Methods of treating allergic reactions using an anhydrous form of antihistaminic piperidine derivatives<disabled in preview>
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International Patent Family for Patent: 7,138,524

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
Japan2002316978Oct 31, 2002
Portugal766668Nov 29, 2002
Japan2002255936Sep 11, 2002
World Intellectual Property Organization (WIPO)9531437Nov 23, 1995
Japan4503909Jul 14, 2010
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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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