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, Indoco, 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, Ivax Sub Teva Pharms, and Ppi-dac, and is included in seventy-eight 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-eight 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:	52
NDAs:	78
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	158
Raw Ingredient (Bulk) Api Vendors:	274
Clinical Trials:	91
Patent Applications:	5,021
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
Emory University	Phase 3
CURE Drug Repurposing Collaboratory (CDRC)	Phase 3
Ruijin Hospital	Phase 1/Phase 2

See all cetirizine hydrochloride clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for cetirizine hydrochloride

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Unichem	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	078680-004	Jun 26, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	090760-004	Aug 5, 2015		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	090142-002	Aug 30, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	078780-002	Jan 21, 2010		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	CETIRIZINE HYDROCHLORIDE HIVES	cetirizine hydrochloride	TABLET;ORAL	078343-002	Jan 15, 2008		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	090188-002	Apr 22, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	ZYRTEC	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007	⤷ Sign Up	⤷ Sign Up
>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
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)	⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011116020		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011003074		⤷ Sign Up
Japan	6449202		⤷ Sign Up
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)	⤷ Sign Up
Spain	2616703		⤷ Sign Up
>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
0663828	C300085	Netherlands	⤷ Sign Up	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	⤷ Sign Up	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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