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, MLV, Perrigo Pharms Co, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Torrent, Wockhardt, Athem, Aurobindo Pharma, 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, Orchid Hlthcare, 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-two patent family members in seven countries.

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

Summary for cetirizine hydrochloride

International Patents:	22
US Patents:	11
Tradenames:	15
Applicants:	49
NDAs:	75
Drug Master File Entries:	39
Suppliers / Packagers:	132
Bulk Api Vendors:	213
Clinical Trials:	78
Patent Applications:	5,007
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
Assiut University	Phase 4
Cairo University	Phase 2/Phase 3
Ciusss de L'Est de l'Île de Montréal	Phase 3

See all cetirizine hydrochloride clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	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	NDA	Submissiondate
ZYRTEC	SYRUP;ORAL	cetirizine hydrochloride	020346	2007-03-19
CHILDREN'S ZYRTEC ALLERGY	TABLET, CHEWABLE;ORAL	cetirizine hydrochloride	021621	2005-03-25
CHILDREN'S ZYRTEC HIVES RELIEF	TABLET, CHEWABLE;ORAL	cetirizine hydrochloride	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
Torrent	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	SYRUP;ORAL	090474-001	Mar 30, 2009		DISCN	No	No	Start Trial	Start Trial				Start Trial
Perrigo R And D	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SYRUP;ORAL	204226-001	Sep 9, 2013		OTC	No	No	Start Trial	Start Trial				Start Trial
Sandoz	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	078692-002	Feb 14, 2008		OTC	No	Yes	Start Trial	Start Trial				Start Trial
Ipca Labs Ltd	CETIRIZINE HYDROCHLORIDE HIVES	cetirizine hydrochloride	TABLET;ORAL	202277-001	Mar 11, 2014		OTC	No	No	Start Trial	Start Trial				Start 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	ZYRTEC	cetirizine hydrochloride	SYRUP;ORAL	020346-001	Sep 27, 1996	Start Trial	Start Trial
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007	Start Trial	Start Trial
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007	Start Trial	Start Trial
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007	Start Trial	Start 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	Estimated Expiration
Japan	6144393	Start Trial
Japan	6449202	Start Trial
Japan	2016190878	Start Trial
World Intellectual Property Organization (WIPO)	2011116020	Start Trial
>Country	>Patent Number	>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	Start 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	Start 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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