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Last Updated: July 23, 2021

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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, Akorn, Alpharma Us Pharms, Anima, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Discovery Therap, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, 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. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for hydroxyzine hydrochloride. Eleven suppliers are listed for this compound.

Summary for HYDROXYZINE HYDROCHLORIDE
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
Vintage HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087603-001 Jan 22, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer VISTARIL hydroxyzine hydrochloride INJECTABLE;INJECTION 011111-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Usl Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089122-001 Mar 20, 1986 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 086821-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 091176-002 Jun 7, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Kv Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087822-001 Jun 23, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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