zyrtec-d 12 hour Drug Patent Profile

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Zyrtec-d 12 Hour is a drug marketed by J And J Consumer Inc and is included in one NDA.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

A generic version of zyrtec-d 12 hour was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	30
Patent Applications:	1
Formulation / Manufacturing:	see details
DailyMed Link:	zyrtec-d 12 hour at DailyMed

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

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

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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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
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	⤷ 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

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

See the table below for patents covering zyrtec-d 12 hour around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20090029314		⤷ Try a Trial
Denmark	154078		⤷ Try a Trial
South Africa	200309720	TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE	⤷ Try a Trial
Australia	1774097		⤷ Try a Trial
Hungary	0400386		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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
0058146	SPC/GB01/052	United Kingdom	⤷ Try a Trial	SPC/GB01/052:, EXPIRES: 20070205
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description