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Generated: January 16, 2018

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Fexofenadine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride; pseudoephedrine hydrochloride has eighty-four patent family members in thirty-two countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Seventeen 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
➤ Subscribe➤ Subscribe60/120MGTABLET, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe60MG; 120MGTABLET, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe60MG; 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
Barr FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076236-001 Apr 14, 2005 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharma Global FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818-001 Jan 29, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Aurobindo Pharma Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209116-001 Oct 30, 2017 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe Y ➤ 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; 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 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 ➤ 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; 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
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
7,147,870 Osmotic device containing pseudoephedrine and an H1 antagonist ➤ Subscribe
6,004,582 Multi-layered osmotic device ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for fexofenadine hydrochloride; pseudoephedrine hydrochloride

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Citi
US Department of Justice
Merck
McKesson
Cerilliant
Chubb
AstraZeneca

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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