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Details for Generic Name: fexofenadine hydrochloride

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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 seventeen 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:14
Applicants:11
NDAs:23
Drug Master File Entries: see list17
Suppliers: see list5
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; 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
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo6,037,353*PED<disabled>Y<disabled>
Mylan
FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL077081-007Jul 21, 2011OTCNo<disabled><disabled>
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
TABLET;ORAL076502-008Apr 12, 2011OTCNo<disabled><disabled>
Dr Reddys Labs Ltd
FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL076502-007Apr 12, 2011OTCNo<disabled><disabled>
Wockhardt Ltd
FEXOFENADINE HYDROCHLORIDE HIVES
fexofenadine hydrochloride
TABLET;ORAL079112-005Feb 8, 2012OTCNo<disabled><disabled>
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International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Publication Date
TaiwanI377061Nov 21, 2012
Australia4909896Sep 18, 1996
Japan2004292459Oct 21, 2004
Canada2466580Jun 07, 2011
China101849917Oct 06, 2010
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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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