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Last Updated: July 21, 2024

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, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hydroxyzine hydrochloride. Forty 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
Sultan Qaboos UniversityPhase 4
The S.N. Fyodorov Eye Microsurgery State InstitutionEarly Phase 1
Minia UniversityPhase 1

See all HYDROXYZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDROXYZINE HYDROCHLORIDE
Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists
Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYZINE HYDROCHLORIDE

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
Purepac Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088120-001 Sep 25, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087329-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 085247-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer ATARAX hydroxyzine hydrochloride TABLET;ORAL 010392-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Pharms HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087410-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pai Holdings Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 040391-001 Apr 10, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040804-001 Jun 30, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.