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Last Updated: October 26, 2021

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Fexofenadine hydrochloride - Generic Drug Details

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

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

Fexofenadine hydrochloride has sixty-two patent family members in thirty-nine countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride. Ninety-eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for fexofenadine hydrochloride
International Patents:62
US Patents:2
Tradenames:13
Applicants:18
NDAs:30
Drug Master File Entries: 23
Finished Product Suppliers / Packagers: 98
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 69
Patent Applications: 2,389
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
Blade TherapeuticsPhase 1
Coloplast A/SPhase 2
Columbia UniversityPhase 2

See all fexofenadine hydrochloride clinical trials

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

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
Teva CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 076447-005 Apr 13, 2011 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Impax Pharms FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076298-001 Nov 12, 2010 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-006 Jan 24, 2011 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-006 Jan 24, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-003 Jan 24, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
AstraZeneca
Boehringer Ingelheim
Merck
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 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.