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Serving leading biopharmaceutical companies globally:

Deloitte
Dow
Merck
Mallinckrodt
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Daiichi Sankyo
US Army
Cerilliant
Colorcon
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Fexofenadine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic drug sources for fexofenadine hydrochloride; pseudoephedrine hydrochloride and what is the scope of fexofenadine hydrochloride; pseudoephedrine hydrochloride patent protection?

Fexofenadine hydrochloride; pseudoephedrine hydrochloride
is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Aurobindo Pharma Ltd, Barr, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharma Global, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride; pseudoephedrine hydrochloride has sixty-seven patent family members in thirty-one countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Fifteen suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for fexofenadine hydrochloride; pseudoephedrine hydrochloride
Pharmacology for fexofenadine hydrochloride; pseudoephedrine hydrochloride
Tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up60/120MGTABLET, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up60MG; 120MGTABLET, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up60MG; 120MGTABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for fexofenadine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Pharms FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076298-001 Nov 12, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076667-001 Nov 18, 2014 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aurobindo Pharma Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209116-001 Oct 30, 2017 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818-001 Jan 29, 2015 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 079043-002 Jun 22, 2011 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076236-001 Apr 14, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for fexofenadine hydrochloride; pseudoephedrine 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
7,147,870 Osmotic device containing pseudoephedrine and an H1 antagonist ➤ Sign Up
6,004,582 Multi-layered osmotic device ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for fexofenadine hydrochloride; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Hong Kong 1019859 ➤ Sign Up
Estonia 200000098 ➤ Sign Up
Japan 5059421 ➤ Sign Up
Norway 318246 ➤ Sign Up
Israel 133420 ➤ Sign Up
Brazil 9812001 ➤ Sign Up
Poland 337348 ➤ Sign Up
Austria 250929 ➤ Sign Up
Brazil 9802144 ➤ Sign Up
Germany 69818607 ➤ Sign Up
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Boehringer Ingelheim
Farmers Insurance
Cipla
McKinsey
Covington
Chubb
Medtronic

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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