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Last Updated: December 7, 2021

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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 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. Additional information is available in the individual branded drug profile pages.

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.

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
⤷  Try it Free⤷  Try it Free60MG;120MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free60/120MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free60MG; 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
Impax Pharms FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076298-001 Nov 12, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818-001 Jan 29, 2015 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209116-001 Oct 30, 2017 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

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