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Last Updated: January 16, 2022

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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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride; pseudoephedrine hydrochloride has forty-six patent family members in thirty-five countries.

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

Summary for cetirizine hydrochloride; pseudoephedrine hydrochloride
Recent Clinical Trials for cetirizine hydrochloride; pseudoephedrine hydrochloride

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

SponsorPhase
Fraunhofer-Institute of Toxicology and Experimental MedicineN/A
GlaxoSmithKlineN/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
Pld Acquisitions CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077991-001 Mar 5, 2008 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Perrigo R And D CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 210719-001 Nov 16, 2018 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Sun Pharm Inds Ltd CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090922-001 Sep 28, 2012 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for cetirizine hydrochloride; pseudoephedrine hydrochloride

Country Patent Number Estimated Expiration
Canada 2451519 ⤷  Sign up for a Free Trial
Denmark 1404304 ⤷  Sign up for a Free Trial
China 100490809 ⤷  Sign up for a Free Trial
South Africa 200309720 ⤷  Sign up for a Free Trial
New Zealand 530289 ⤷  Sign up for a Free Trial
South Korea 20040007756 ⤷  Sign up for a Free Trial
Australia 2002345024 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for cetirizine hydrochloride; pseudoephedrine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663828 C300085 Netherlands ⤷  Sign up for a Free 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 ⤷  Sign up for a Free 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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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Medtronic
Harvard Business School
Johnson and Johnson
Dow

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