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Last Updated: August 10, 2020

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HYDROXYZINE HYDROCHLORIDE Drug Profile

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When do Hydroxyzine Hydrochloride patents expire, and when can generic versions of Hydroxyzine Hydrochloride launch?

Hydroxyzine Hydrochloride is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Anima, Hi Tech Pharma, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Eci Pharms Llc, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, Nuvo Pharm, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Usl Pharma, and Vintage. and is included in one hundred and three NDAs.

The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Hydroxyzine Hydrochloride

A generic version of HYDROXYZINE HYDROCHLORIDE was approved as hydroxyzine hydrochloride by WOCKHARDT BIO AG on April 12th, 1982.

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Drug patent expirations by year for HYDROXYZINE HYDROCHLORIDE
Recent Clinical Trials for HYDROXYZINE HYDROCHLORIDE

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SponsorPhase
Assiut UniversityPhase 4
Istanbul Medeniyet UniversityPhase 4
University of WashingtonPhase 4

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Pharmacology for HYDROXYZINE HYDROCHLORIDE
Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists

US Patents and Regulatory Information for HYDROXYZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kv Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087820-001 Jun 23, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088551-001 Oct 22, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089071-001 Jul 22, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Hi Tech Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 040010-001 Oct 28, 1994 AA RX No Yes   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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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Harvard Business School
Express Scripts
Boehringer Ingelheim
Johnson and Johnson

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