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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 seventeen 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: see list1

Pharmacology for Tradename: ALLEGRA

Clinical Trials for: ALLEGRA

Preference for Clarinex Tablets vs Allegra Tablets in Patients With Seasonal Allergies (P03178)
Status: Completed Condition: Seasonal Allergic Rhinitis

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03179)
Status: Completed Condition: Seasonal Allergic Rhinitis

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)
Status: Completed Condition: Seasonal Allergic Rhinitis

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers
Status: Completed Condition: Healthy

The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Status: Completed Condition: Allergic Rhinitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-009Jan 24, 2011OTCYes5,855,912*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-009Jan 24, 2011OTCYes7,135,571*PED<disabled><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>
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>
6,187,791 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
Germany69320952Oct 15, 1998
Australia679910Jul 17, 1997
Austria194913Aug 15, 2000
Norway307688May 15, 2000
Mexico9302704Jun 30, 1994
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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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