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HYDROXYZINE HYDROCHLORIDE Drug Profile

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When do Hydroxyzine Hydrochloride patents expire, and what generic alternatives are available?

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 12^th, 1982.

Summary for HYDROXYZINE HYDROCHLORIDE

US Patents:	0
Applicants:	46
NDAs:	103
Suppliers / Packagers:	37
Bulk Api Vendors:	144
Clinical Trials:	28
Patent Applications:	4,437
Formulation / Manufacturing:	see details
DailyMed Link:	HYDROXYZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for HYDROXYZINE HYDROCHLORIDE

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

Sponsor	Phase
Assiut University	Phase 4
Istanbul Medeniyet University	Phase 4
University of Washington	Phase 4

See all HYDROXYZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDROXYZINE HYDROCHLORIDE

Drug Class	Antihistamine
Mechanism of Action	Histamine 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
Quantum Pharmics	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	088551-001	Oct 22, 1985		DISCN	No	No
Actavis Elizabeth	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	089071-001	Jul 22, 1986		DISCN	No	No
Hi Tech Pharma	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	040010-001	Oct 28, 1994	AA	RX	No	Yes
Northstar Hlthcare	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040840-001	Mar 31, 2008	AB	RX	No	No
Superpharm	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	088795-001	Dec 5, 1984		DISCN	No	No
Aurobindo Pharma Ltd	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	087871-001	Dec 20, 1982		DISCN	No	No