ZYRTEC Drug Patent Profile

Which patents cover Zyrtec, and when can generic versions of Zyrtec launch?

Zyrtec is a drug marketed by J And J Consumer Inc and is included in four NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ZYRTEC is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyrtec

A generic version of ZYRTEC was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

Summary for ZYRTEC

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	30
Patent Applications:	3,181
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for ZYRTEC
What excipients (inactive ingredients) are in ZYRTEC?	ZYRTEC excipients list
DailyMed Link:	ZYRTEC at DailyMed

See drug sales revenues for ZYRTEC

Recent Clinical Trials for ZYRTEC

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

Sponsor	Phase
Emory University	Phase 4
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 1
Indiana University	Phase 4

See all ZYRTEC clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ZYRTEC

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 ZYRTEC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC	Syrup	cetirizine hydrochloride	5 mg/5 mL	020346	1	2007-03-19

US Patents and Regulatory Information for ZYRTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SYRUP;ORAL	020346-001	Sep 27, 1996		DISCN	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
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-004	Nov 16, 2007		OTC	Yes	Yes

Expired US Patents for ZYRTEC

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

International Patents for ZYRTEC

See the table below for patents covering ZYRTEC around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	5388
New Zealand	199650	2-(4-(DIPHENYLMETHYL)-1-PIPERAZINYL)-ACETIC ACID DERIVATIVES
Germany	3260282

Supplementary Protection Certificates for ZYRTEC

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
0058146	SPC/GB01/052	United Kingdom		SPC/GB01/052:, EXPIRES: 20070205