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Last Updated: February 2, 2023

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 Chattem Sanofi, Barr, P And L, Taro, Dr Reddys Labs Ltd, Aurolife Pharma Llc, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Wockhardt, L Perrigo Co, Granules, Sciegen Pharms Inc, Unique Pharm Labs, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-one 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. Ninety-five 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:31
Drug Master File Entries: 21
Finished Product Suppliers / Packagers: 95
Raw Ingredient (Bulk) Api Vendors: 121
Clinical Trials: 75
Patent Applications: 2,532
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
Eurofarma Laboratorios S.A.Phase 3
In Vitro Research Solutions Private LimitedPhase 1
OrchestratePharma GmbHPhase 1

See all fexofenadine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing60MG;120MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing60/120MGTABLET, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing60MGTABLET; 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 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
Rising FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride TABLET;ORAL 077081-002 Apr 11, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Barr FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride TABLET;ORAL 076191-003 Aug 31, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Ltd CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076502-004 Apr 12, 2011 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SUSPENSION;ORAL 201373-002 Jan 24, 2011 See Plans and Pricing See Plans and Pricing
Chattem Sanofi ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-009 Jan 24, 2011 See Plans and Pricing See Plans and Pricing
Chattem Sanofi ALLEGRA fexofenadine hydrochloride SUSPENSION;ORAL 021963-001 Oct 16, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fexofenadine hydrochloride

Country Patent Number Title Estimated Expiration
Russian Federation 2405538 КОМПОЗИЦИЯ СУСПЕНЗИИ ФЕКСОФЕНАДИНА (COMPOSITION OF FEXOFENADINE SUSPENSION) See Plans and Pricing
New Zealand 568943 Fexofenadine suspension formulation See Plans and Pricing
Honduras 2008000875 PROCESO PARA PREPARAR UNA FORMULACION DE SUSPENSION DE FEXOFENADINA See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.