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Last Updated: July 3, 2020

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ZYRTEC Drug Profile


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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 three Paragraph IV challenges.

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

US ANDA Litigation and Generic Entry Outlook for Zyrtec

Zyrtec was eligible for patent challenges on December 8, 1999.

There are three Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for ZYRTEC
Drug patent expirations by year for ZYRTEC
Drug Sales Revenue Trends for ZYRTEC

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Recent Clinical Trials for ZYRTEC

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SponsorPhase
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 1
Northwestern UniversityEarly Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early Phase 1

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Paragraph IV (Patent) Challenges for ZYRTEC
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC SYRUP;ORAL cetirizine hydrochloride 020346 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   Start Trial   Start Trial   Start 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   Start Trial   Start Trial   Start Trial
J And J Consumer Inc ZYRTEC ALLERGY cetirizine hydrochloride TABLET;ORAL 019835-004 Nov 16, 2007 OTC Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial Y   Start Trial
J And J Consumer Inc ZYRTEC ALLERGY cetirizine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022578-001 Sep 3, 2010 OTC Yes Yes   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

Supplementary Protection Certificates for ZYRTEC

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Merck
Mallinckrodt
Baxter
McKinsey

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