Cetirizine hydrochloride - Generic Drug Details

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

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
		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

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

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
Eyevance	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes					Y
Jubilant Generics	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	091116-003	Feb 19, 2015		OTC	No	No
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077498-002	Dec 27, 2007		OTC	No	No
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes
Sun Pharm	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	090142-002	Aug 30, 2011		OTC	No	No

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
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007

International Patents for cetirizine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	7088980
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)
World Intellectual Property Organization (WIPO)	2011003074
European Patent Office	2547340	FORMULATIONS OPHTHALMIQUES DE CÉTIRIZINE ET LEURS MÉTHODES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)
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)
Spain	2910374

Supplementary Protection Certificates for cetirizine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663828	C300085	Netherlands		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		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103