CHILDREN'S ZYRTEC ALLERGY Drug Patent Profile

Which patents cover Children's Zyrtec Allergy, and what generic alternatives are available?

Children's Zyrtec Allergy is a drug marketed by J And J Consumer Inc and is included in two NDAs.

The generic ingredient in CHILDREN'S ZYRTEC ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Children's Zyrtec Allergy

A generic version of CHILDREN'S ZYRTEC ALLERGY was approved as cetirizine hydrochloride by TEVA PHARMS on May 27^th, 2008.

Summary for CHILDREN'S ZYRTEC ALLERGY

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	4
Patent Applications:	2,658
Formulation / Manufacturing:	see details
DailyMed Link:	CHILDREN'S ZYRTEC ALLERGY at DailyMed

Recent Clinical Trials for CHILDREN'S ZYRTEC ALLERGY

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
Merck Sharp & Dohme Corp.	Phase 3
Pfizer	Phase 4

See all CHILDREN'S ZYRTEC ALLERGY clinical trials

Pharmacology for CHILDREN'S ZYRTEC ALLERGY

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CHILDREN'S ZYRTEC ALLERGY

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

US Patents and Regulatory Information for CHILDREN'S ZYRTEC ALLERGY

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	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	SYRUP;ORAL	022155-002	Nov 16, 2007		OTC	Yes	Yes
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007		DISCN	Yes	No
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-007	Nov 30, 2020		DISCN	Yes	No

Expired US Patents for CHILDREN'S ZYRTEC ALLERGY

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	021621-003	Nov 16, 2007
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007

International Patents for CHILDREN'S ZYRTEC ALLERGY

See the table below for patents covering CHILDREN'S ZYRTEC ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2007091760	PHARMACEUTICAL AGENT FOR ORAL ADMINISTRATION COMPRISING ACTIVE INGREDIENT AND CYCLODEXTRIN
Latvia	5494	2-Ú4-(difenilmetil)-1-piperazinil3⁄4-etikskabes vai to amidi vai to netoksiskie farmaceitiski pielaujamie sali ar spazmolitisku un antihistamina darbibu
Spain	8406455

Supplementary Protection Certificates for CHILDREN'S ZYRTEC ALLERGY

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