DrugPatentWatch Database Preview
Cetirizine hydrochloride - Generic Drug Details
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
| International Patents: | 15 |
| US Patents: | 7 |
| Tradenames: | 14 |
| Applicants: | 46 |
| NDAs: | 72 |
| Drug Master File Entries: | 39 |
| Suppliers / Packagers: | 154 |
| Bulk Api Vendors: | 192 |
| Clinical Trials: | 71 |
| Patent Applications: | 4,779 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | cetirizine hydrochloride at DailyMed |
Recent Clinical Trials for cetirizine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Frontage Laboratories, Inc. | Phase 1 |
| Seattle Gummy Company | Phase 1 |
| Frontage Clinical Services, Inc. | Phase 1 |
Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 5MG/5ML | SYRUP;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
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
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 |
International Patents for cetirizine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2011116020 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010107689 | Start Trial |
| European Patent Office | 2408453 | Start Trial |
| Japan | 2012520882 | Start Trial |
| >Country | >Patent Number | >Estimated 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.