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Last Updated: April 6, 2020

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Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details

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What are the generic sources for cetirizine hydrochloride; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Cetirizine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Ivax Sub Teva Pharms, Perrigo R And D, Pld Acquisitions, Sun Pharm Inds Ltd, and J And J Consumer Inc, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride; pseudoephedrine hydrochloride has fifty-eight patent family members in forty countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride; pseudoephedrine hydrochloride. Thirty suppliers are listed for this compound.

Summary for cetirizine hydrochloride; pseudoephedrine hydrochloride
International Patents:58
US Patents:3
Tradenames:2
Applicants:5
NDAs:5
Drug Master File Entries: 39
Suppliers / Packagers: 30
Clinical Trials: 4
DailyMed Link:cetirizine hydrochloride; pseudoephedrine hydrochloride at DailyMed
Recent Clinical Trials for cetirizine hydrochloride; pseudoephedrine hydrochloride

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SponsorPhase
GlaxoSmithKlineN/A
Fraunhofer-Institute of Toxicology and Experimental MedicineN/A
SandozPhase 1

See all cetirizine hydrochloride; pseudoephedrine hydrochloride clinical trials

Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
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 cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077170-001 Feb 25, 2008 OTC 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 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 cetirizine hydrochloride; pseudoephedrine hydrochloride

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 cetirizine hydrochloride; pseudoephedrine hydrochloride

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

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Medtronic
Harvard Business School
Johnson and Johnson
Dow

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.