ZYRTEC Drug Patent Profile

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Zyrtec is a drug marketed by J And J Consumer Inc and is included in four NDAs.

The generic ingredient in ZYRTEC 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 was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	30
Patent Applications:	2,859
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

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

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

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

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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	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996		DISCN	No	No	⤷ Try a Trial	⤷ 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		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-004	Nov 16, 2007		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022578-001	Sep 3, 2010		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-003	Nov 16, 2007		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	019835-006	Nov 16, 2007		DISCN	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996	⤷ 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 around the world.

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Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	1287749	"CПOCOБ ПOЛУЧEHИЯ 2-/4-/ДИФEHИЛMETИЛ/-1-ПИПEPAЗИHИЛ-УKCУCHЫX KИCЛOT ИЛИ ИX HETOKCИЧHЫX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ" (METHOD OF PRODUCING 2-/4-(DIPHENYLMETHYL)-1-PIPERAZINYL/-ACETIC ACIDS OR NONTOXIC PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF)	⤷ Try a Trial
Japan	S57149282	2-(4-(DIPHENYLMETHYL)-1-PIPERAZINYL)ACETIC ACID AND THEIR DERIVATIVES AS MEDICINE	⤷ Try a Trial
Finland	820318		⤷ Try a Trial
Denmark	155796		⤷ Try a Trial
Cyprus	1307	2-(4-(DIPHENYLMETHYL)-1-PIPERAZINYL)-ACETIC ACIDS AND THEIR AMIDES,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS	⤷ Try a Trial
Norway	820297		⤷ 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	SPC/GB01/052	United Kingdom	⤷ Try a Trial	SPC/GB01/052:, EXPIRES: 20070205
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