CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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

Cetirizine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Ivax Sub Teva Pharms, Perrigo R And D, Pld Acquisitions, Sun Pharm Inds Ltd, and J And J Consumer Inc, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride; pseudoephedrine hydrochloride has forty-six patent family members in thirty-five countries.

Twenty-five suppliers are listed for this compound.

Summary for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

International Patents:	46
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	25
Clinical Trials:	4
DailyMed Link:	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fraunhofer-Institute of Toxicology and Experimental Medicine	N/A
GlaxoSmithKline	N/A
Sandoz	Phase 1

See all CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC-D 12 HOUR	Extended-release Tablets	cetirizine hydrochloride; pseudoephedrine hydrochloride	5 mg/120 mg	021150	1	2004-06-02

US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210719-001	Nov 16, 2018		OTC	No	No
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090922-001	Sep 28, 2012		OTC	No	No
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007		OTC	Yes	Yes
Ivax Sub Teva Pharms	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077170-001	Feb 25, 2008		OTC	No	No
Pld Acquisitions	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077991-001	Mar 5, 2008		OTC	No	No

Expired US Patents for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007

International Patents for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	530289	Pharmaceutical composition comprising cetirizine and pseudoephedrine that contains less than 5% or no alkalinising agent
World Intellectual Property Organization (WIPO)	03002098
Slovakia	15502003	Tableta obsahujúca cetirizín a pseudoefedrín (Tablet comprising cetirizine and pseudoephedrine)
Austria	432068
Canada	2451519	COMPRIME CONTENANT DE LA CETIRIZINE ET DE LA PSEUDOEPHEDRINE (TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE)

Supplementary Protection Certificates for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE 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