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Last Updated: April 18, 2024

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, 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-five 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:	155
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
Torrent Pharms Llc	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	079191-003	Apr 15, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bionpharma	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	CAPSULE;ORAL	022429-003	Jul 23, 2009		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cypress Pharm	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	090300-001	Oct 10, 2008		DISCN	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	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	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
Spain	2616703		⤷ Try a Trial
Japan	2015007136	セチリジンの眼科用製剤および使用方法 (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)	⤷ Try a Trial
Japan	2016190879	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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