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Serving leading biopharmaceutical companies globally:

Queensland Health
Cerilliant
Colorcon
McKesson
QuintilesIMS
Dow
Healthtrust
Johnson and Johnson
UBS
Merck

Generated: January 19, 2018

DrugPatentWatch Database Preview

Fexofenadine hydrochloride - Generic Drug Details

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What are the generic sources for fexofenadine hydrochloride and what is the scope of fexofenadine hydrochloride freedom to operate?

Fexofenadine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Sanofi Aventis Us, Barr, Actavis Mid Atlantic, Taro Pharm, Dr Reddys Labs Ltd, Aurolife Pharma Llc, Hetero Labs Ltd V, Mylan, Sun Pharm Inds, Teva, Wockhardt Ltd, Sciegen Pharms Inc, Aurobindo Pharma Ltd, Impax Pharms, and Sun Pharma Global, and is included in twenty-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has seventy-eight patent family members in forty-one countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride. One hundred and two suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for fexofenadine hydrochloride
Pharmacology for fexofenadine hydrochloride
Tentative approvals for FEXOFENADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe60/120MGTABLET, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe30MGTABLET; ORAL
➤ Subscribe➤ Subscribe180MGTABLET; ORAL

US Patents and Regulatory Information for fexofenadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Ltd FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 079112-005 Feb 8, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sciegen Pharms Inc FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204507-002 Sep 16, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-008 Jan 24, 2011 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Inds CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 091567-001 Feb 6, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurolife Pharma Llc CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 202039-001 Nov 19, 2014 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride TABLET;ORAL 076502-002 Apr 11, 2006 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-002 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Inds FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 091567-003 Feb 6, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride TABLET;ORAL 076447-001 Sep 1, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for fexofenadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-010 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-005 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-009 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-005 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA fexofenadine hydrochloride CAPSULE;ORAL 020625-001 Jul 25, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-010 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA fexofenadine hydrochloride CAPSULE;ORAL 020625-001 Jul 25, 1996 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,187,791 Method of providing an antihistaminic effect in a hepatically impaired patient ➤ Subscribe
6,399,632 Method of providing an antihistaminic effect in a hepatically impaired patient ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for fexofenadine hydrochloride

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Express Scripts
Moodys
Merck
Chinese Patent Office
Daiichi Sankyo
Accenture
Queensland Health

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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