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HYDROXYZINE HYDROCHLORIDE Drug Profile

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Which patents cover Hydroxyzine Hydrochloride, and when can generic versions of Hydroxyzine Hydrochloride launch?

Hydroxyzine Hydrochloride is a drug marketed by Altana, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Luitpold, 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, Aurolife Pharma Llc, 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-three 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 January 17^th, 2020.

Summary for HYDROXYZINE HYDROCHLORIDE

US Patents:	0
Applicants:	46
NDAs:	103
Suppliers / Packagers:	33
Bulk Api Vendors:	142
Clinical Trials:	27
Patent Applications:	4,391
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
Istanbul Medeniyet University	Phase 4
University of Washington	Phase 4
Foundation for a Smoke-Free World	Phase 4

See all HYDROXYZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDROXYZINE HYDROCHLORIDE

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Synonyms for HYDROXYZINE HYDROCHLORIDE

(+-)-2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol dihydrochloride

(+/-)-2-(2-{4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl}ethoxy)ethanol hydrochloride

0635AC

1-(4-Chloro-alpha-phenylbenzyl)-4-((2-(2-hydroxyethoxy)ethyl)piperazine)

1-(p-Chloro-.alpha.-phenylbenzyl)-4-(2-((2-hydroxyethoxy)ethyl)piperazine

1-(p-Chloro-.alpha.-phenylbenzyl)-4-[2-[(2-hydroxyethoxy)ethyl]piperazine

1-(p-Chloro-alpha-phenylbenzyl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine

1-(p-Chloro-alpha-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine

1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)diethylenediamine

1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)diethylenediamine hydrochloride

1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine

1-(p-Chlorobenzhydryl)-4-[2-(2-hydroxyethoxy)ethyl]diethylenediamine

1-(p-Chlorobenzhydryl)-4-[2-(2-hydroxyethoxy)ethyl]piperazine

1-(p-Chlorodiphenylmethyl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine

1-(p-Chlorodiphenylmethyl)-4-[2-(2-hydroxyethoxy)ethyl]piperazine

10246-75-0 (pamoate)

1244-76-4

14729-22-7

163837-38-5

192H203

2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethan-1-ol dihydrochloride

2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethanol

2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethanol dihydrochloride

2-(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol

2-(2-(4-((4-Chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)ethanol hydrochloride

2-(2-(4-(p-Chloro-.alpha.-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol

2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol

2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol dihydrochloride

2-(2-(4-[(4-Chlorophenyl)(phenyl)methyl]-1-piperazinyl)ethoxy)ethanol #

2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethan-1-ol

2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethanol

2-(2-{4-[(4-chlorophenyl)phenylmethyl]piperazinyl}ethoxy)ethan-1-ol

2-(2-{4-[(4-chlorphenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethanoldihydrochlorid

2-[(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethyl)oxy]ethanol

2-[2-[4-(p-Chloro-.alpha.-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol

2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]ethanol

2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]ethanol dihydrochloride

2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]ethanol hydrochloride

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol dihydrochloride

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol hydrochloride

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol;dihydrochloride

2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]ethanol

2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanol hydrochloride

2192-20-3

2192-20-3 (di-hydrochloride)

24155-EP2275420A1

24155-EP2295409A1

24155-EP2298764A1

24155-EP2298765A1

24155-EP2314590A1

242H772

39081-05-5

5-23-01-00462 (Beilstein Handbook Reference)

68-88-2

AB00053485

AB00053485_24

AB00053485_25

AB0005753

AC-8086

AC1L1GFB

AC1L2GHI

AC1L3M8D

AC1Q3ADT

AC1Q3BAY

AI3-50162

AK-54930

AKOS003334349

AKOS015846478

AKOS016843978

AKOS022179621

Alamon

AN-22368

AN-41909

AN-8376

ANOMHKZSQFYSBR-UHFFFAOYSA-N

ANW-45296

API0002955

API0004808

Arcanax

Atara

Atarax

Atarax (Salt/Mix)

Atarax (TN)

Atarax base

Atarax dihydrochloride

Ataraxoid

Ataraxoid dihydrochloride

Atarazoid

Atarox

Atazina

Aterax

Atranine A

AX8032687

BBL034752

BC204943

BC252494

BCP08800

BDBM22875

BPBio1_000228

BRD-A62428732-096-02-6

BRD-A62428732-300-03-0

BRN 0321392

BSPBio_000206

C07045

C21H27ClN2O2

C21H27ClN2O2.2HCl

C21H27ClN2O2.ClH

C21H29Cl3N2O2

CAS-1244-76-4

CAS-68-88-2

CCG-220133

CHEBI:5818

CHEBI:5819

CHEMBL1201007

CHEMBL3186993

CHEMBL896

CPD001496937

CS-2650

CS-2651

CTK8B4497

CTK8G0241

CTK8G7211

D00672

D08054

DB00557

Deinait

Dichlorhydrate de 1-p.chlorbenzhydryl-4-(2-(2-hydroxyethoxy)ethyl)piperazine

Dichlorhydrate de 1-p.chlorbenzhydryl-4-(2-(2-hydroxyethoxy)ethyl)piperazine [French]

Disron

Disron (Salt/Mix)

DSSTox_CID_27530

DSSTox_CID_3137

DSSTox_GSID_23137

DSSTox_GSID_47530

DSSTox_RID_76887

DSSTox_RID_82400

DTXSID2040737

DTXSID5047530

DTXSID8023137

Durrax

Durrax (Salt/Mix)

EINECS 200-693-1

EINECS 214-989-3

EINECS 218-586-3

Equipoise

ETH012

Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-

Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)- (9CI)

Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride

Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride, (+-)-

Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, hydrochloride (1:2)

Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-

Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, dihydrochloride

Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, hydrochloride

Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, monohydrochloride

Ethanol, 2-[2-[4-(p-chloro-.alpha.-phenylbenzyl)-1-piperazinyl]ethoxy]-

Ethanol, 2-[2-[4-(p-chloro-phenylbenzyl)-1-piperazinyl]ethoxy]-

Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-

Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, dihydrochloride

Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, hydrochloride (1:2)

Ethanol,2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-

Fenarol

FT-0658716

FT-0670239

GTPL7199

H965

Hidroxizina

Hidroxizina [INN-Spanish]

HMS1568K08

HMS3604B10

HS-0097

HSDB 3098

HY-B0548

HY-B0548A

Hy-Pam 25

Hychotine

Hydroksyzyny

Hydroksyzyny [Polish]

Hydroxine

Hydroxizine

HYDROXIZINE CHLORIDE

Hydroxizinum

Hydroxycine

Hydroxyzin

hydroxyzin hydrochloride

hydroxyzine

Hydroxyzine (dihydrochloride)

Hydroxyzine (INN)

Hydroxyzine [INN:BAN]

Hydroxyzine 2HCl

Hydroxyzine base

Hydroxyzine DiHCl

Hydroxyzine dihydrochloride

Hydroxyzine dihydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material

Hydroxyzine dihydrochloride, >=98%

Hydroxyzine Dihydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Hydroxyzine Hcl

Hydroxyzine hydrochloride (JP17/USP)

Hydroxyzine hydrochloride [USAN]

Hydroxyzine hydrochloride [USP:JAN]

Hydroxyzine Hydrochloride 1.0 mg/ml in Methanol (as free base)

Hydroxyzine hydrochloride, European Pharmacopoeia (EP) Reference Standard

Hydroxyzine hydrochloride, United States Pharmacopeia (USP) Reference Standard

Hydroxyzine Hydrochloride,(S)

Hydroxyzine monohydrochloride

Hydroxyzine pound>>NSC 169188 pound>>U.C.B 4492

HYDROXYZINE TRANQUIZINE

Hydroxyzine, (R)

Hydroxyzine(dihydrochloride)

Hydroxyzinum

Hydroxyzinum [INN-Latin]

Hydroxyzyne

Idrossizina

Idrossizina [DCIT]

IPSVAUIEEPSJRZ-UHFFFAOYSA-N

KB-220361

KB-226876

KB-296265

KS-000019VL

KS-00001F80

L000930

LS-66601

LS-66602

LS-66604

Marax

Marex (TN)

MFCD00058200

MLS000028602

MLS002222192

MolPort-001-531-967

MolPort-002-506-318

MRF-0000015

N-(4-Chlorobenzhydryl)-N'-(hydroxyethoxyethyl)piperazine

N-(4-Chlorobenzhydryl)-N'-(hydroxyethyloxyethyl)piperazine

NCGC00018255-02

NCGC00018255-03

NCGC00018255-04

NCGC00018255-06

NCGC00021152-06

NCGC00089816-02

NCGC00089816-03

NCGC00180974-01

NCGC00256629-01

neo-Calma

Neurolax

Neurozina

Nevrolaks

NP 212

NSC 169188

NSC-169188

NSC169188

Opera_ID_1515

Orgatrax

Pamazone

Parenteral

Paxistil

Placidol

Plaxidol

Prestwick_272

Prestwick0_000133

Prestwick1_000133

Prestwick2_000133

Prestwick3_000133

Quiess

QYS

s4026

SAM002589941

SCHEMBL41448

SCHEMBL4491

SCHEMBL491323

SMR000058737

SPBio_002145

SR-01000003137

SR-01000003137-2

ST059726

ST2403814

STL417960

SW196577-3

TC-063555

Tox21_113569

Tox21_113569_1

Tox21_302563

Tran-Q

Tran-Q dihydrochloride

Tranquizine

Tranquizine dihydrochloride

Traquizine

U.C.B 4492

U.CB 4492

UCB 4492

UCB 492

UCB-4492

Vesparaz-Wirkstoff

Vistaject

Vistarex

Vistaril

Vistaril (Salt/Mix)

Vistaril (TN)

Vistaril Parenteral

Vistaril steraject

Vistazine

VU0239818-5

W-107513

W0041

WLN: T6N DNTJ AYR&R D6& D2O2Q

ZQDWXGKKHFNSQK-UHFFFAOYSA-N

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