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Cetirizine hydrochloride - Generic Drug Details

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What are the generic drug sources for cetirizine hydrochloride and what is the scope of cetirizine hydrochloride patent protection?

Cetirizine hydrochloride is the generic ingredient in fourteen branded drugs marketed by Apotex Inc, Bionpharma Inc, Strides Pharma, Eyevance Pharms, Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Aurobindo Pharma, Cypress Pharm, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharma Global, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in sixty-eight NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride has thirty-eight patent family members in twenty-one countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride. One hundred and sixty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for cetirizine hydrochloride

International Patents:	38
US Patents:	7
Tradenames:	14
Applicants:	41
NDAs:	68
Drug Master File Entries:	39
Suppliers / Packagers:	161
Bulk Api Vendors:	170
Clinical Trials:	65
Patent Applications:	4,814
Formulation / Manufacturing:	see details
DailyMed Link:	cetirizine hydrochloride at DailyMed

Pharmacology for cetirizine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for cetirizine hydrochloride

Anti-Allergic Agents

Histamine H1 Antagonists, Non-Sedating

Synonyms for cetirizine hydrochloride

(+-)-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic acid, dihydrochloride

(+) {2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazine-1-yl] -ethoxy}-acetic acid dihydrochloride

(+/-)-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl] ethoxy]acetic acid, dihydrochloride

(+/-){2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]-ethoxy}-acetic acid dihydrochloride

(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic acid

(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic acid dihydrochloride

(2-{4-[(4-Chloro-phenyl)-phenyl-methyl]-piperazin-1-yl}-ethoxy)-acetic acid

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

(2-{4-[(4-Chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid (2HCl)

(R) -2-[2-[4-[(4-Chlorophenyl) Phenylmethyl] Piperazin-1-yl]Ethoxy]Acetic Acid Dihydrochloride

(R)-2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride

(RS)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy }-acetic acid dihydrochloride

(RS)-{2-[4-(alpha-phenyl-p-chlorobenzyl)-piperazin-1-yl]ethoxy}-acetic acid dihydrochloride

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

[2-[4-[(4-Chlorophenyl)-phenyl methyl]-1-piperazinyl] ethoxy] acetic acid

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

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

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

[2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride

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

110271-EP2284166A1

110271-EP2298415A1

130018-82-5

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

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

2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid hydrochloride

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

2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazino}ethoxy)acetic acid

2-(2-{4-[(4-chlorophenyl)phenylmethyl]piperazinyl}ethoxy)acetic acid

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

2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]acetic acid dihydrichloride

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

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

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid dihydrochloride

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

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

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

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

24161-EP2272832A1

24161-EP2281815A1

24161-EP2295409A1

24161-EP2301933A1

24161-EP2305640A2

24161-EP2311827A1

24161-EP2314590A1

2469AC

798544-25-9

81C510

83881-51-0

83881-51-0 (Parent)

83881-52-1

83881-52-1 (di-hydrochloride)

881C510

881C521

A10107

A840675

AB0008484

AB0019096

AB1009381

AC-1600

AC-5545

AC1L1E7T

AC1L1IJL

AC1Q768B

Acetic acid, (2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-

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

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

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

ACETIC ACID,[2-[4-[(R)-(4-CHLOROPHENYL)PHENYLMETHYL]-1-PIPERAZINYL]ETHOXY]-,MONOHYDROCHLORIDE

AK-57294

AK108356

AK307945

AKOS000280979

AKOS003589059

AKOS016002146

AKOS016340521

AKOS021729457

Alercet

Alergex

Alerid

Alerlisin

Alertisin

Allergy relief

Alleroff

AN-10906

AN-14770

AN-15756

ANW-58920

ANW-69482

API0001938

API0025650

Apo-Cetirizine

AX8022801

AX8041242

AX8323094

BB_SC-2161

BBL009968

BDBM22890

Benaday

BG0436

BPBio1_000469

BRD-A42571354-300-05-4

BSPBio_000425

BSPBio_002302

C-5854

C07778

C21H25ClN2O3

C21H25ClN2O3.2HCl

C21H26Cl2N2O3

C21H27Cl3N2O3

CAS-83881-52-1

CC0153

CC0256

CCG-213404

Cetalerg

Ceterifug

Ceti TAD

Ceti-Puren

Cetiderm

Cetiderm (TN)

Cetidura

Cetil von ct

CetiLich

Cetirigamma

Cetirizin

Cetirizin AZU

Cetirizin Basics

Cetirizin dihydrochloride, >=98.0% (HPLC)

Cetirizina

Cetirizina [Spanish]

cetirizine

Cetirizine (dihydrochloride)

Cetirizine (INN)

Cetirizine [INN:BAN]

Cetirizine 2HCl

Cetirizine Di

Cetirizine diHCl

Cetirizine dihydrochloride

Cetirizine Dihydrochloride 1.0 mg/ml in Water (as free base)

Cetirizine dihydrochloride solution, 1.0 mg/mL in acetonitrile: water (9:1) (as free base), ampule of 1 mL, certified reference material

Cetirizine dihydrochloride, >=98% (HPLC)

Cetirizine dihydrochloride, European Pharmacopoeia (EP) Reference Standard

Cetirizine dihydrochloride, United States Pharmacopeia (USP) Reference Standard

Cetirizine for peak identification, European Pharmacopoeia (EP) Reference Standard

Cetirizine HCl

Cetirizine hydrochloride (JP17/USAN)

Cetirizine hydrochloride [USAN:USP]

Cetirizine hydrochloride [USAN]

Cetirizine Hydrochloride Allergy

Cetirizine Hydrochloride Hives

Cetirizine Hydrochloride, pharmaceutical secondary standard;traceable to USP, PhEur, BP

CETIRIZINE HYDROCHLORIDE/ CETIRIZINE DIHYDROCHLORIDE

cetirizinedihydrochloride

CetirizineHydrochloride

cetirizinhydrochlorid

Cetirizinum

Cetirizinum [Latin]

Cetirlan

Cetriler

Cetrine

Cetrizide

Cetrizine Dihcl

Cetrizine Hcl

Cetryn

Cetzine

Cezin

CHEBI:3561

CHEBI:3562

CHEMBL1000

CHEMBL1201113

CHEMBL1607273

Children's Cetirizine hydrochloride allergy

Children's Cetirizine hydrochloride hives relief

Children's Zyrtec

Children's Zyrtec Allergy

Children's Zyrtec Hives Relief

CPD001453715

CS-0886

CS-1798

CTK7J5576

CTK8B7912

CTK8C2999

CUSPGNDCPOVPBA-UHFFFAOYSA-N

D00664

D07662

D0DK8V

DB00341

DR002244

DSSTox_CID_24268

DSSTox_GSID_44268

DSSTox_RID_80138

DTXSID2044268

DTXSID4022787

EN300-52521

Formistin

FT-0603000

FT-0603001

FT-0654660

GTPL1222

HE180669

HE180670

HE180671

HE392232

HE395488

Hitrizin Film Tablet

HMS1539O07

HMS1569F07

HMS1922H04

HMS3259D06

HMS3370I19

HMS3393N10

HSDB 7739

HY-17042

HY-17042A

I06-0389

I06-0454

I14-0479

J-005737

J10151

KB-220360

KS-000015AD

KS-1042

L000655

LP00362

LS-11409

LS-11411

MCULE-8668839822

MFCD00800721

MFCD00941428

MLS000551288

MLS002222268

MolPort-000-832-941

MolPort-002-506-309

MolPort-003-939-603

NC00696

NCGC00016949-01

NCGC00095180-01

NCGC00095180-02

NCGC00167781-01

NCGC00167781-02

NCGC00167781-03

NCGC00167781-04

NCGC00167781-07

NCGC00255965-01

NCGC00261047-01

NCGC00263567-01

NSC-759102

NSC759102

P 071

P-071

PGLIUCLTXOYQMV-UHFFFAOYSA-N

Pharmakon1600-01505371

Prestwick_841

Prestwick0_000503

Prestwick1_000503

Prestwick2_000503

Prestwick3_000503

Reactine

Reactine (TN)

Ressital

Riztec

RT-007014

RTR-026026

Ryzen

s1291

Salvalerg

SAM002548972

SAM002589989

SBI-0206838.P001

SC-17992

SC-18167

SC-19204

SC-19390

SCHEMBL41107

SCHEMBL41108

SCHEMBL4176

Setir

Setiral

SMR000145214

SPBio_002346

SPECTRUM1505371

ST024755

ST077146

ST24039138

ST51051458

STK711108

STOCK2S-03020

Stopaler

Sun mark all day allergy

TC-147665

TimTec1_002075

Topcare all day allergy

Tox21_110704

Tox21_110704_1

Tox21_302261

Tox21_500362

Triz

U095

UCB-P 071

Up and up all day allergy relief

Virdos

Virlix

Voltric

Xero-sed

Z1182332250

Zerviate

Zetir

Ziptek

Zirtek

Zirtin

ZKLPARSLTMPFCP-UHFFFAOYSA-N

Zyrlex

Zyrtec

Zyrtec (TN)

Zyrtec Allergy

Zyrtec Hives Relief

Zyrtec Syrup

Zyrtec-D

Zyrzine

Tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		5MG/5ML	SYRUP;ORAL

US Patents and Regulatory Information for cetirizine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyevance Pharms	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes			Y
Eyevance Pharms	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007		DISCN	Yes	No			Y
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077498-001	Dec 27, 2007		OTC	No	No

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Expired US Patents for cetirizine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SYRUP;ORAL	020346-001	Sep 27, 1996

Non-Orange Book US Patents for cetirizine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,569,273	Ophthalmic formulations of cetirizine and methods of use

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International Patents for cetirizine hydrochloride

Country	Document Number	Estimated Expiration
New Zealand	501820
Denmark	0994710
Israel	133397
Japan	6144393

Supplementary Protection Certificates for cetirizine hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
01C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103