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Last Updated: October 27, 2020

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LEVOCETIRIZINE DIHYDROCHLORIDE Drug Profile

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When do Levocetirizine Dihydrochloride patents expire, and when can generic versions of Levocetirizine Dihydrochloride launch?

Levocetirizine Dihydrochloride is a drug marketed by Apotex, L Perrigo Co, Lannett Co Inc, Taro Pharm Inds Ltd, Dr Reddys Labs Ltd, Fosun Pharma, Glenmark Generics, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Neopharma, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms. and is included in twenty-one NDAs.

The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE 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 Dihydrochloride

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

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Drug patent expirations by year for LEVOCETIRIZINE DIHYDROCHLORIDE
Drug Prices for LEVOCETIRIZINE DIHYDROCHLORIDE

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Drug Sales Revenue Trends for LEVOCETIRIZINE DIHYDROCHLORIDE

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Recent Clinical Trials for LEVOCETIRIZINE DIHYDROCHLORIDE

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

See all LEVOCETIRIZINE DIHYDROCHLORIDE clinical trials

Pharmacology for LEVOCETIRIZINE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for LEVOCETIRIZINE DIHYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
XYZAL ALLERGY 24HR SOLUTION;ORAL levocetirizine dihydrochloride 209090 2018-01-04
XYZAL SOLUTION;ORAL levocetirizine dihydrochloride 022157 2009-01-14
XYZAL TABLET;ORAL levocetirizine dihydrochloride 022064 2007-12-17

US Patents and Regulatory Information for LEVOCETIRIZINE DIHYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 202915-001 Aug 21, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090362-001 Jan 31, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 210375-001 Jan 19, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride SOLUTION;ORAL 202673-001 Jul 26, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 205564-001 Jan 11, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Synthon Pharms LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET;ORAL 090229-001 Nov 26, 2010 AB 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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