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Details for Generic Name: fexofenadine hydrochloride; pseudoephedrine hydrochloride

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Fexofenadine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Barr, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharma Global, and is included in seven NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in thirty-one countries.

There are sixteen drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Tradenames:3
Patents:8
Applicants:5
NDAs:7
Drug Master File Entries: see list16
Suppliers: see list5
Formulation / Manufacturing:see details

Pharmacology for Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60/120MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60MG; 120MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60MG; 120MG

Clinical Trials for: fexofenadine hydrochloride; pseudoephedrine hydrochloride

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

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

Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Status: Completed Condition: Rhinitis Seasonal

A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Status: Completed Condition: Allergic Rhinitis

Evaluation of Efficacy of Dellegra in Exposure Unit
Status: Completed Condition: Rhinitis Allergic

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
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Pharms
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076298-001Nov 12, 2010RXNo<disabled><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>Y<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><disabled>
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076667-001Nov 18, 2014OTCNo<disabled><disabled>
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>
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International Patent Family for Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Publication Date
Germany60134387Jul 24, 2008
China1228020Sep 08, 1999
Argentina043468Jul 27, 2005
China1158071Jul 21, 2004
European Patent Office0998272May 10, 2000
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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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