HYDROXYZINE HYDROCHLORIDE Drug Patent Profile

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, Akorn, Alpharma Us Pharms, Anima, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Torrent, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Biopharm, Epic Pharma Llc, 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 ninety-nine NDAs.

The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

DrugPatentWatch^® 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:	45
NDAs:	99
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	183
Clinical Trials:	29
Patent Applications:	4,110
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
Mongi Slim Hospital	N/A
Assiut University	Phase 4
Istanbul Medeniyet University	Phase 4

See all HYDROXYZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDROXYZINE HYDROCHLORIDE

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYZINE HYDROCHLORIDE

N05BB	Diphenylmethane derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Rising	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	091176-002	Jun 7, 2010		DISCN	No	No
Actavis Elizabeth	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	089071-001	Jul 22, 1986		DISCN	No	No
Anima	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	086880-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nuvo Pharms Inc	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	207121-003	Mar 29, 2017	AB	RX	No	No