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Last Updated: March 19, 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. Thirty-five 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
Minia UniversityPhase 1
Mongi Slim HospitalN/A

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
Chartwell Rx HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040804-003 Jun 30, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Northstar Hlthcare HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040840-002 Mar 31, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 091176-002 Jun 7, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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