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Last Updated: November 2, 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 four 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: 104
Raw Ingredient (Bulk) Api Vendors: 127
Clinical Trials: 79
Patent Applications: 2,621
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
Bristol-Myers SquibbPhase 1
Dhaka Medical CollegePhase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi CompanyPhase 3

See all fexofenadine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up60MG;120MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up60/120MGTABLET, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up180MGTABLET; 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
Chattem Sanofi ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020786-002 Jan 24, 2011 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 202978-001 Jan 18, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 OTC Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Wockhardt CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 079112-001 Feb 8, 2012 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Chattem Sanofi CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-006 Jan 24, 2011 ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-003 Jan 24, 2011 ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-006 Jan 24, 2011 ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi ALLEGRA fexofenadine hydrochloride CAPSULE;ORAL 020625-001 Jul 25, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.