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Last Updated: November 15, 2019

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ZYRTEC-D 12 HOUR Drug Profile

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Which patents cover Zyrtec-d 12 Hour, and when can generic versions of Zyrtec-d 12 Hour launch?

Zyrtec-d 12 Hour is a drug marketed by J And J Consumer Inc and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-eight patent family members in forty countries.

The generic ingredient in ZYRTEC-D 12 HOUR 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.

Summary for ZYRTEC-D 12 HOUR
International Patents:58
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 28
Formulation / Manufacturing:see details
DailyMed Link:ZYRTEC-D 12 HOUR at DailyMed
Drug patent expirations by year for ZYRTEC-D 12 HOUR
Recent Clinical Trials for ZYRTEC-D 12 HOUR

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

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

See all ZYRTEC-D 12 HOUR clinical trials

Synonyms for ZYRTEC-D 12 HOUR
913966-97-9
Allergy relief D
Cetire D
Cetirizine / Pseudoephedrine
Cetirizine mixture with Pseudoephedrine
Pseudoephedrine mixture with Cetirizine
SCHEMBL3467271
WAL ZYR D
Paragraph IV (Patent) Challenges for ZYRTEC-D 12 HOUR
Tradename Dosage Ingredient NDA Submissiondate
ZYRTEC-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL cetirizine hydrochloride; pseudoephedrine hydrochloride 021150 2004-06-02

US Patents and Regulatory Information for ZYRTEC-D 12 HOUR

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   Start Trial   Start Trial Y   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-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
>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 ZYRTEC-D 12 HOUR

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   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   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYRTEC-D 12 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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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