Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: fexofenadine hydrochloride

« Back to Dashboard
Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Sanofi Aventis Us, Barr, Actavis Mid Atlantic, Dr Reddys Labs Ltd, Aurolife Pharma Llc, Mylan, Sun Pharm Inds, Teva, Wockhardt Ltd, Impax Pharms, and Sun Pharma Global, and is included in twenty-three NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and five patent family members in forty-one countries.

There are sixteen drug master file entries for fexofenadine hydrochloride. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: fexofenadine hydrochloride

Tradenames:13
Patents:14
Applicants:11
NDAs:23
Drug Master File Entries: see list16
Suppliers: see list4
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: fexofenadine hydrochloride

Tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL60/120MG
<disabled><disabled>TABLET; ORAL180MG
<disabled><disabled>TABLET; ORAL30MG

Clinical Trials for: fexofenadine hydrochloride

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 Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
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

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

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

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
Sanofi Aventis Us
ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 2011OTCNo5,932,247*PED<disabled>Y<disabled>
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL076502-009Apr 12, 2011OTCNo<disabled><disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes7,138,524*PED<disabled><disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo5,855,912*PED<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes7,135,571*PED<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Publication Date
Hong Kong1069340Feb 02, 2007
Peru10032007Oct 03, 2007
Ukraine89584Feb 10, 2010
Japan5308824Oct 09, 2013
Uruguay30021Jul 31, 2007
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

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 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn
`abc