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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 eighteen 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 list18
Suppliers / Packaging: see list29
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; ORAL60MG
<disabled><disabled>TABLET; ORAL180MG

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
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 2006RXYes7,138,524*PED<disabled><disabled>
Sanofi Aventis Us
ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-007Jan 24, 2011OTCNo6,037,353*PED<disabled>Y<disabled>
Actavis Mid Atlantic
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
SUSPENSION;ORAL203330-001Nov 18, 2014OTCNo<disabled><disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-002Jan 24, 2011OTCYes5,738,872<disabled>Y<disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes7,135,571*PED<disabled><disabled>
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International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Publication Date
Ukraine89584Feb 10, 2010
World Intellectual Property Organization (WIPO)9626726Sep 06, 1996
Hungary9802086Jan 28, 1999
Uruguay30021Jul 31, 2007
Canada2633086Oct 18, 2011
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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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