Deep knowledge on 
 small-molecule drugs and 
 the 110,000 global patents 
 covering them 

Free Patent Expiration Alerts


Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Fexofenadine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

« Back to Dashboard
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 one hundred and thirteen patent family members in thirty-four countries.

There are twenty-one drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Sixteen 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 list21
Suppliers / Packaging: see list16
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076236-001Apr 14, 2005DISCNNo<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 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 2011OTCYesRE39069<disabled>Y <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

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, 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, 20115,855,912*PED<disabled>
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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

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
5,932,247 Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
8,129,408Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: fexofenadine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Canada2213700<disabled in preview>
China1158071<disabled in preview>
Chile2004000317<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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

Connect with Social Media:

`abc