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Last Updated: December 1, 2021

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ZYRTEC Drug Patent 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 one Paragraph IV challenge.

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

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
Emory UniversityPhase 4
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 1
Indiana UniversityPhase 4

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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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
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 it Free ⤷  Try it Free ⤷  Try it Free
J And J Consumer Inc ZYRTEC ALLERGY cetirizine hydrochloride TABLET;ORAL 019835-004 Nov 16, 2007 OTC Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 SPC/GB01/052 United Kingdom ⤷  Try it Free SPC/GB01/052:, EXPIRES: 20070205
0663828 C300085 Netherlands ⤷  Try it Free 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 ⤷  Try it Free 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:

Medtronic
Moodys
Merck
Mallinckrodt
Baxter
McKinsey

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