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Last Updated: November 18, 2019

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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 patent protection?

Cetirizine hydrochloride is the generic ingredient in fourteen branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Eyevance, Quagen, Actavis Mid Atlantic, Amneal Pharms, Breckenridge, Lannett Co Inc, MLV, Perrigo Pharms Co, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, Wockhardt, Athem, Aurobindo Pharma, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, 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 seventy-two 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 fifteen patent family members in five countries.

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

Summary for cetirizine hydrochloride
Recent Clinical Trials for cetirizine hydrochloride

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

SponsorPhase
Frontage Laboratories, Inc.Phase 1
Seattle Gummy CompanyPhase 1
Frontage Clinical Services, Inc.Phase 1

See all cetirizine hydrochloride clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG/5MLSYRUP;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for cetirizine hydrochloride
Medical Subject Heading (MeSH) Categories for cetirizine hydrochloride
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-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]-
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
BBL009968
BCP08787
BCP09018
BCP28477
BDBM22890
Benaday
BG0436
BPBio1_000469
BRD-A42571354-300-05-4
BRD-A42571354-300-07-0
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, British Pharmacopoeia (BP) Reference Standard
Cetirizine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Cetirizine Hydrochloride,(S)
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
DB00341
DSSTox_CID_24268
DSSTox_GSID_44268
DSSTox_RID_80138
DTXSID2044268
DTXSID4022787
EN300-52521
Formistin
FT-0603000
FT-0603001
FT-0654660
GTPL1222
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
Levocetirizine HCl
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
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
SR-01000688282
SR-01000688282-3
ST024755
ST077146
ST24039138
STK711108
Stopaler
Sun mark all day allergy
SW196972-3
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
Xarlin
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
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC SYRUP;ORAL cetirizine hydrochloride 020346 2007-03-19
CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25
CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25

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
Ipca Labs Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 202277-004 Mar 11, 2014 OTC No No   Start Trial   Start Trial   Start Trial
Wockhardt CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078427-003 Dec 28, 2007 OTC No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 090751-001 Dec 16, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 090142-001 Aug 30, 2011 OTC No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-005 Nov 16, 2007   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-006 Nov 16, 2007   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for cetirizine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663828 C300085 Netherlands   Start Trial 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
0058146 2001C/045 Belgium   Start Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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