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Last Updated: April 13, 2024

ZYRTEC-D 12 HOUR Drug Patent Profile


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When do Zyrtec-d 12 Hour patents expire, 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.

The generic ingredient in ZYRTEC-D 12 HOUR 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.

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

See all ZYRTEC-D 12 HOUR clinical trials

Paragraph IV (Patent) Challenges for ZYRTEC-D 12 HOUR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYRTEC-D 12 HOUR Extended-release Tablets cetirizine hydrochloride; pseudoephedrine hydrochloride 5 mg/120 mg 021150 1 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 ⤷  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

Expired US Patents for ZYRTEC-D 12 HOUR

International Patents for ZYRTEC-D 12 HOUR

See the table below for patents covering ZYRTEC-D 12 HOUR around the world.

Country Patent Number Title Estimated Expiration
Poland 206069 ⤷  Try a Trial
Slovakia 15502003 Tableta obsahujúca cetirizín a pseudoefedrín (Tablet comprising cetirizine and pseudoephedrine) ⤷  Try a Trial
U.S.S.R. 1227113 "CПOCOБ ПOЛУЧEHИЯ 2-/4/ДИФEHИЛMETИЛ/-1-ПИПEPAЗИHИЛ/-AЦETAMИДA ИЛИ EГO COЛEЙ ПPИCOEДИHEHИЯ HETOKCИЧHЫX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX KИCЛOT" (METHOD OF PRODUCING 2-(4-)DIPHENYLMETHYL(-1-PIPERAZINYL)-ACETAMIDE OR ITS SALTS CONNECTING NONTOXIC PHARMACEUTICALLY ACCEPTABLE ACIDS) ⤷  Try a Trial
Spain 8307776 ⤷  Try a Trial
Denmark 5388 ⤷  Try a Trial
Taiwan I243061 ⤷  Try a Trial
Malaysia 129643 TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYRTEC-D 12 HOUR

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
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.