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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

Drug Master File Entries: see list17
Suppliers / Packaging: see list28
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: 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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
fexofenadine hydrochloride
SUSPENSION;ORAL201373-002Jan 24, 2011OTCYes8,933,097<disabled>Y<disabled>
Sanofi Aventis Us
fexofenadine hydrochloride
TABLET;ORAL020872-006Jan 24, 2011OTCNo6,037,353*PED<disabled>Y<disabled>
Sanofi Aventis Us
fexofenadine hydrochloride
TABLET;ORAL020872-010Jan 24, 2011OTCYes5,932,247*PED<disabled>Y<disabled>
Dr Reddys Labs Ltd
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL079043-002Jun 22, 2011OTCNo<disabled><disabled>
Sanofi Aventis Us
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 2011OTCYes6,723,348<disabled>Y<disabled>
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International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Publication Date
Canada2466580Jun 07, 2011
Japan2005513008May 12, 2005
Japan2008266347Nov 06, 2008
Argentina058323Jan 30, 2008
South Korea100405116Feb 05, 2004
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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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