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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, Sun Pharma Global, Barr, Dr Reddys Labs Ltd, and Impax Pharms, and is included in seven NDAs. There are six 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 twenty 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:6
Applicants:5
NDAs:7
Drug Master File Entries: see list20
Suppliers / Packaging: see list25

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

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 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes5,855,912*PED<disabled> <disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,113,942*PED<disabled> <disabled>
Impax Pharms
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076298-001Nov 12, 2010RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20116,399,632*PED<disabled>
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 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 20116,187,791*PED<disabled>
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International Patent Family for Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Publication Date
Slovakia177799Jul 11, 2000
Czech Republic9904581May 17, 2000
Indonesia22891Dec 16, 1999
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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