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Last Updated: March 29, 2024

Fexofenadine hydrochloride - Generic Drug Details


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

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Chattem Sanofi, Barr, P And L, Taro, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Wockhardt, L Perrigo Co, Granules, Sciegen Pharms Inc, Unique, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has forty-three patent family members in thirty-eight countries.

There are twenty-one drug master file entries for fexofenadine hydrochloride. One hundred and one suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for fexofenadine hydrochloride
International Patents:43
US Patents:1
Tradenames:13
Applicants:19
NDAs:32
Drug Master File Entries: 21
Finished Product Suppliers / Packagers: 101
Raw Ingredient (Bulk) Api Vendors: 127
Clinical Trials: 78
Patent Applications: 2,629
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in fexofenadine hydrochloride?fexofenadine hydrochloride excipients list
DailyMed Link:fexofenadine hydrochloride at DailyMed
Recent Clinical Trials for fexofenadine hydrochloride

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

SponsorPhase
Dhaka Medical CollegePhase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi CompanyPhase 3
Eurofarma Laboratorios S.A.Phase 3

See all fexofenadine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial60MG;120MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial60/120MGTABLET, EXTENDED RELEASE; ORAL
⤷  Try a Trial⤷  Try a Trial180MGTABLET; ORAL

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

Pharmacology for fexofenadine hydrochloride
Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CHILDREN'S ALLEGRA HIVES Oral Suspension (OTC) fexofenadine hydrochloride 30 mg/5 mL 201373 1 2010-01-25

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
Dr Reddys Labs Ltd CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202978-001 Jan 18, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 079112-001 Feb 8, 2012 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-009 Jan 24, 2011 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818-001 Jan 29, 2015 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076447-004 Apr 13, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride SUSPENSION;ORAL 201311-001 Jul 25, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076502-006 Apr 12, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

International Patents for fexofenadine hydrochloride

Country Patent Number Title Estimated Expiration
Denmark 1965768 ⤷  Try a Trial
Norway 339877 ⤷  Try a Trial
Japan 5308824 ⤷  Try a Trial
Costa Rica 9993 FORMULACIÓN DE SUSPENSIÓN DE FEXOFENADINA ⤷  Try a Trial
Russian Federation 2405538 КОМПОЗИЦИЯ СУСПЕНЗИИ ФЕКСОФЕНАДИНА (COMPOSITION OF FEXOFENADINE SUSPENSION) ⤷  Try a Trial
South Africa 200803985 Fexofenadine suspension formulation ⤷  Try a Trial
China 101316580 Fexofenadine suspension formulation ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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