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Profile for Tradename: ALLEGRA ALLERGY

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

The generic ingredient in ALLEGRA ALLERGY is fexofenadine hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for Tradename: ALLEGRA ALLERGY

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list23

Pharmacology for Tradename: ALLEGRA ALLERGY

Clinical Trials for: ALLEGRA ALLERGY

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms
Status: Completed Condition: Cat Induced Allergic Rhinitis

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

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
Status: Completed Condition: Seasonal Allergic Rhinitis

Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.
Status: Completed Condition: Allergy

Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
Status: Completed Condition: Allergy; Rhinitis; Conjunctivitis

A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Status: Completed Condition: Rhinitis

Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
Status: Completed Condition: Hay Fever; Hypersensitivity; Allergy; Rhinitis

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
Status: Completed Condition: Seasonal 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 ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-007Jan 24, 2011OTCNo7,138,524*PED<disabled><disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes6,113,942*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-007Jan 24, 2011OTCNo6,037,353*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes7,135,571*PED<disabled><disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes6,037,353*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: ALLEGRA ALLERGY

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>
5,738,872 Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
7,666,881Methods of treating allergic reactions using hydrated forms of antihistaminic piperidine derivatives<disabled in preview>
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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