Deep knowledge on 
 small-molecule drugs and 
 the 100,000 global patents 
 covering them 

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

How are People Using DrugPatentWatch?

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 Dr Reddys Labs Ltd, Sciegen Pharms Inc, Sanofi Aventis Us, Actavis Mid Atlantic, Wockhardt Ltd, Aurolife Pharma Llc, Teva, Sun Pharm Inds, Barr, Mylan, Sun Pharma Global, and Impax Pharms, and is included in twenty-four NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-two patent family members in forty countries.

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

Summary for Generic Name: fexofenadine hydrochloride

Tradenames:13
Patents:11
Applicants:12
NDAs:24
Drug Master File Entries: see list20
Suppliers / Packaging: see list29
Therapeutic Class:Respiratory Tract Agents

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; ORAL30MG
<disabled><disabled>TABLET; ORAL60MG

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc
FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL204507-003Sep 16, 2015OTCNo<disabled><disabled>
Actavis Mid Atlantic
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
SUSPENSION;ORAL203330-001Nov 18, 2014OTCNo<disabled><disabled>
Wockhardt Ltd
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL079112-001Feb 8, 2012OTCNo<disabled><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

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 HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-008Jan 24, 20116,187,791*PED<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 20117,138,524*PED<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 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.

International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Publication Date
Egypt25866Sep 12, 2012
Portugal1965768Aug 07, 2009
CroatiaP20090411Jan 31, 2010
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 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 2002-2016 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