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Last Updated: May 28, 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, Breckenridge, Lannett Co Inc, Micro Labs, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, 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, 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-five patent family members in seven countries.

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

Summary for cetirizine hydrochloride
International Patents:25
US Patents:11
Tradenames:15
Applicants:49
NDAs:75
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 135
Raw Ingredient (Bulk) Api Vendors: 239
Clinical Trials: 88
Patent Applications: 5,129
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
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078343-004 Jan 15, 2008 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Orbion Pharms CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078862-002 Feb 19, 2009 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007 See Plans and Pricing See Plans and Pricing
J And J Consumer Inc ZYRTEC cetirizine hydrochloride SYRUP;ORAL 020346-001 Sep 27, 1996 See Plans and Pricing See Plans and Pricing
J And J Consumer Inc CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-006 Nov 16, 2007 See Plans and Pricing See Plans and Pricing
>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 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:

Mallinckrodt
Dow
Express Scripts
Boehringer Ingelheim
Colorcon
Moodys

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.