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Last Updated: March 29, 2024

FEXOFENADINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Fexofenadine Hydrochloride, and what generic alternatives are available?

Fexofenadine Hydrochloride is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm. and is included in twenty-two NDAs.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for FEXOFENADINE HYDROCHLORIDE
Drug patent expirations by year for FEXOFENADINE HYDROCHLORIDE
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

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 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 079043-002 Jun 22, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076447-006 Apr 13, 2011 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 204507-005 Sep 16, 2015 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

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