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Last Updated: April 27, 2024

CETIRIZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for cetirizine hydrochloride and what is the scope of freedom to operate?

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-four 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:	154
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

Sponsor	Phase
State University of New York - Upstate Medical University	Phase 3
Ultragenyx Pharmaceutical Inc	Phase 1/Phase 2
Emory University	Phase 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 Trial	5MG/5ML	SOLUTION;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

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Amneal Pharms	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	090765-002	Oct 7, 2009		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pld Acquisitions	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077991-001	Mar 5, 2008		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE HIVES	cetirizine hydrochloride	TABLET;ORAL	077498-004	Dec 27, 2007		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Perrigo R And D	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	090254-002	Apr 9, 2008		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	SOLUTION;ORAL	201546-002	May 20, 2011		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	CETIRIZINE HYDROCHLORIDE HIVES	cetirizine hydrochloride	TABLET;ORAL	076677-003	Dec 27, 2007		OTC	No	No	⤷ 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

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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	⤷ 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	ZYRTEC	cetirizine hydrochloride	SOLUTION;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	021621-006	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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2547340	FORMULATIONS OPHTHALMIQUES DE CÉTIRIZINE ET LEURS MÉTHODES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)	⤷ Try a Trial
Japan	2018141022	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)	⤷ Try a Trial
Japan	2020117544	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)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011003074		⤷ Try a Trial
European Patent Office	3943069	FORMULATIONS OPHTALMIQUESDE CETIRIZINE ET PROCEDES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)	⤷ Try a Trial
European Patent Office	2408453	FORMULATIONS OPHTALMIQUES DE CÉTIRIZINE ET PROCÉDÉS D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)	⤷ Try a Trial
Japan	2021138760	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)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CETIRIZINE HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
>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.