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Last Updated: March 3, 2024

Cetirizine hydrochloride - Generic Drug Details


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

Cetirizine hydrochloride is the generic ingredient in fifteen branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Catalent, Strides Pharma, Harrow Eye, JDP, Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Bajaj, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Aurobindo Pharma, Chartwell Rx, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Quagen, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, and Ivax Sub Teva Pharms, and is included in seventy-six NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for cetirizine hydrochloride
International Patents:28
US Patents:9
Tradenames:15
Applicants:50
NDAs:76
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 153
Raw Ingredient (Bulk) Api Vendors: 274
Clinical Trials: 88
Patent Applications: 5,098
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in cetirizine hydrochloride?cetirizine hydrochloride excipients list
DailyMed Link:cetirizine hydrochloride at DailyMed
Recent Clinical Trials for cetirizine hydrochloride

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

SponsorPhase
State University of New York - Upstate Medical UniversityPhase 3
Ultragenyx Pharmaceutical IncPhase 1/Phase 2
Emory UniversityPhase 4

See all cetirizine hydrochloride clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYRTEC Syrup cetirizine hydrochloride 5 mg/5 mL 020346 1 2007-03-19
CHILDREN'S ZYRTEC HIVES RELIEF Chewable Tablets cetirizine hydrochloride 5 mg and 10 mg 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
Dr Reddys Labs Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078343-004 Jan 15, 2008 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077498-001 Dec 27, 2007 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unique CETIRIZINE HYDROCHLORIDE HIVES cetirizine hydrochloride TABLET;ORAL 077829-002 Aug 26, 2009 OTC No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-005 Nov 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-003 Nov 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for cetirizine hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2011116020 ⤷  Try a Trial
Japan 2012520882 ⤷  Try a Trial
European Patent Office 2547340 FORMULATIONS OPHTHALMIQUES DE CÉTIRIZINE ET LEURS MÉTHODES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cetirizine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663828 C300085 Netherlands ⤷  Try a 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 ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.