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Fexofenadine hydrochloride - Generic Drug Details

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

There are twenty-one drug master file entries for fexofenadine hydrochloride. Ninety-four 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 list21
Suppliers / Packaging: see list94
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

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, 2011OTCNo6,113,942*PED<disabled> <disabled>
Barr
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076236-001Apr 14, 2005DISCNNo<disabled><disabled>
Sanofi Aventis Us
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020786-002Jan 24, 2011OTCYes6,037,353*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-002Jan 24, 20117,138,524<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA HIVES
fexofenadine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021909-003Jan 24, 20116,187,791<disabled>
Sanofi Aventis Us
CHILDREN'S ALLEGRA ALLERGY
fexofenadine hydrochloride
TABLET;ORAL020872-005Jan 24, 20116,187,791*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: fexofenadine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,129,408Pharmaceutical composition for piperidinoalkanol compounds<disabled in preview>
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient<disabled in preview>
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International Patent Family for Ingredient: fexofenadine hydrochloride

Country Document Number Estimated Expiration
Japan2008266347<disabled in preview>
South Africa9601389<disabled in preview>
Chile2004000317<disabled in preview>
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