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Last Updated: August 15, 2020

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CHILDREN'S ZYRTEC ALLERGY Drug Profile

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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-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

US ANDA 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 27th, 2008.

  Start Trial

Drug patent expirations by year for CHILDREN'S ZYRTEC ALLERGY
Recent Clinical Trials for CHILDREN'S ZYRTEC ALLERGY

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 4
Merck Sharp & Dohme Corp.Phase 3
Johnson & Johnson Consumer and Personal Products WorldwidePhase 4

See all CHILDREN'S ZYRTEC ALLERGY clinical trials

Paragraph IV (Patent) Challenges for CHILDREN'S ZYRTEC ALLERGY
Tradename Dosage Ingredient NDA Submissiondate
CHILDREN'S ZYRTEC HIVES RELIEF TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25
CHILDREN'S ZYRTEC ALLERGY TABLET, CHEWABLE;ORAL cetirizine hydrochloride 021621 2005-03-25

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   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-003 Nov 16, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621-004 Nov 16, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CHILDREN'S ZYRTEC ALLERGY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0058146 SPC/GB01/052 United Kingdom   Start Trial SPC/GB01/052:, EXPIRES: 20070205
0663828 C300085 Netherlands   Start 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 2001C/045 Belgium   Start Trial PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Colorcon
Harvard Business School
Medtronic
Merck

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