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Last Updated: November 28, 2020

DrugPatentWatch Database Preview

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 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 Pharm, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride; pseudoephedrine hydrochloride has twelve patent family members in eleven countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride; pseudoephedrine hydrochloride. Twenty-one suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for fexofenadine hydrochloride; pseudoephedrine hydrochloride
International Patents:12
US Patents:1
Tradenames:3
Applicants:6
NDAs:8
Drug Master File Entries: 23
Suppliers / Packagers: 21
Clinical Trials: 4
DailyMed Link:fexofenadine hydrochloride; pseudoephedrine hydrochloride at DailyMed
Recent Clinical Trials for fexofenadine hydrochloride; pseudoephedrine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
SanofiPhase 4
SanofiPhase 3
Dr. Reddy's Laboratories LimitedPhase 1

See all fexofenadine hydrochloride; pseudoephedrine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG;120MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial60/120MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial60MG; 120MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

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
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   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209116-001 Oct 30, 2017 OTC No No   Start Trial   Start Trial   Start Trial
Impax Pharms FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076298-001 Nov 12, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Barr FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076236-001 Apr 14, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fexofenadine hydrochloride; pseudoephedrine hydrochloride

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Moodys
Johnson and Johnson
Harvard Business School
Dow

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 verification 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.