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Last Updated: April 22, 2024

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 Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Perrigo R And D, Pld Acquisitions, Sun Pharm Inds Ltd, and J And J Consumer Inc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-six 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

Pharmacology for cetirizine hydrochloride; pseudoephedrine hydrochloride
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
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 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
Aurobindo Pharma Ltd CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212409-001 Mar 8, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  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 cetirizine hydrochloride; pseudoephedrine hydrochloride

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