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Last Updated: September 29, 2020

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LEVOCETIRIZINE HYDROCHLORIDE Drug Profile

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When do Levocetirizine Hydrochloride patents expire, and what generic alternatives are available?

Levocetirizine Hydrochloride is a drug marketed by Hetero Labs Ltd Iii and is included in one NDA.

The generic ingredient in LEVOCETIRIZINE HYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Levocetirizine Hydrochloride

A generic version of LEVOCETIRIZINE HYDROCHLORIDE was approved as levocetirizine dihydrochloride by SYNTHON PHARMS on November 26th, 2010.

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Summary for LEVOCETIRIZINE HYDROCHLORIDE
Drug patent expirations by year for LEVOCETIRIZINE HYDROCHLORIDE
Recent Clinical Trials for LEVOCETIRIZINE HYDROCHLORIDE

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

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 4
University Hospital, GrenoblePhase 4
Zensei Pharmaceutical Co., Ltd.Phase 1

See all LEVOCETIRIZINE HYDROCHLORIDE clinical trials

Pharmacology for LEVOCETIRIZINE HYDROCHLORIDE

US Patents and Regulatory Information for LEVOCETIRIZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii LEVOCETIRIZINE HYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 210914-001 Apr 1, 2019 AA RX No No   Start Trial   Start Trial   Start 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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