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Last Updated: August 13, 2020

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HYDROXYZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for hydroxyzine hydrochloride and what is the scope of patent protection?

Hydroxyzine hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Organon Usa Inc, Pfizer, Roerig, 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 seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for hydroxyzine hydrochloride. Thirty-seven suppliers are listed for this compound.

Recent Clinical Trials for HYDROXYZINE HYDROCHLORIDE

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

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

See all HYDROXYZINE HYDROCHLORIDE clinical trials

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
Pliva HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088619-001 Jan 10, 1986 AB RX No Yes   Start Trial   Start Trial   Start Trial
Amneal Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040808-001 Sep 24, 2008 AB RX 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
Sun Pharm Industries HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089382-001 May 19, 1986 DISCN 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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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Mallinckrodt
Dow
Boehringer Ingelheim
McKesson

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