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Last Updated: December 2, 2022

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 Inc, Catalent, Strides Pharma, Eyevance, JDP, Actavis Mid Atlantic, Amneal Pharms, Atlantide, Bajaj, Breckenridge, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, 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 Pharm Labs, and Ivax Sub Teva Pharms, and is included in seventy-five NDAs. There are eleven 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 thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for cetirizine hydrochloride
International Patents:28
US Patents:11
Tradenames:15
Applicants:51
NDAs:75
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 136
Raw Ingredient (Bulk) Api Vendors: 254
Clinical Trials: 88
Patent Applications: 5,301
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
See Plans and PricingSee Plans and Pricing5MG/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
Torrent CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride SYRUP;ORAL 090474-001 Mar 30, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eyevance ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694-001 May 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jubilant Generics CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 091116-003 Feb 19, 2015 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077498-002 Dec 27, 2007 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jdp QUZYTTIR cetirizine hydrochloride SOLUTION;INTRAVENOUS 211415-001 Oct 4, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 090142-002 Aug 30, 2011 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for cetirizine hydrochloride

Country Patent Number Title Estimated Expiration
Japan 7088980 See Plans and Pricing
Japan 2020117545 セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011003074 See Plans and Pricing
European Patent Office 2547340 FORMULATIONS OPHTHALMIQUES DE CÉTIRIZINE ET LEURS MÉTHODES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE) See Plans and Pricing
Canada 2803987 FORMULATIONS POUR INJECTION D'UN ANTIHISTAMINIQUE NON SEDATIF ET LEURS METHODES D'UTILISATION (NON-SEDATING ANTIHISTAMINE INJECTION FORMULATIONS AND METHODS OF USE THEREOF) See Plans and Pricing
Spain 2910374 See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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