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NDA

CETIRIZINE HYDROCHLORIDE | N020346 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Blue Cross of California - Citizen Petition FDA-1998-P-0254 · 3 docket documents Blue Cross of California, filed under 21 CFR 10.30, petitioned the FDA to convert six prescription antihistamine medications—Allegra, Allegra-D, Claritin, Claritin-D, Claritin-D 24 Hour, and Zyrtec—to over-the-counter status, arguing these selective antihistamines are safer than currently available	Other	2009-04-30	Open	—
Citizen Petition from Strides Inc. FDA-2006-P-0286 · 4 docket documents Strides Inc. filed a citizen petition regarding cetirizine hydrochloride products, specifically referencing Orange Book data for Pfizer's Zyrtec formulations across multiple dosage forms and strengths including tablets, chewable tablets, and syrup, as well as the combination product Zyrtec-D 12 Hour	Other	2009-04-20	Denied	Strides Inc.
Citizen Petition from Greenberg Traurig LLP FDA-2007-P-0056 · 5 docket documents Greenberg Traurig LLP filed this citizen petition on March 12, 2007 requesting that the FDA switch Allegra (fexofenadine hydrochloride) in multiple formulations under NDAs 20625, 20872, and 21963, Allegra D under NDAs 20786 and 21704, and Zyrtec (cetirizine hydrochloride) under NDAs 19835, 21621, an	Other	2008-04-11	Withdrawn	Greenberg Traurig LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

71 trials from ClinicalTrials.gov, 65 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Perennial Allergic Rhinitis In Pediatric Subjects NCT00257595	Phase 3	Completed	GlaxoSmithKline	30	2005-08
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension NCT01127620	Phase 3	Completed	Faes Farma, S.A.	650	2004-05 → 2006-11
Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis NCT00490204	Phase 3	Completed	GlaxoSmithKline	239	2007-07-27 → 2007-10-03
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo NCT00851344	Phase 2	Completed	GlaxoSmithKline	54	2008-09 → 2008-11
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition NCT01064102	Phase 1	Completed	Dr. Reddy's Laboratories Limited	30	2006-01 → 2006-02
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis NCT01748344	Phase 2	Completed	Ono Pharmaceutical Co., Ltd.	58	2012-11
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions NCT00881127	Phase 1	Completed	Sandoz	40	2005-07 → 2005-07
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition NCT01064115	Phase 1	Completed	Dr. Reddy's Laboratories Limited	30	2006-01 → 2006-02
A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine NCT01103050	Phase 2	Completed	Novartis Pharmaceuticals	60	2010-03-22 → 2010-07-28
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis NCT01916226	Phase 4	Completed	GlaxoSmithKline	682	2013-08-01 → 2013-10-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain12 active DMFs3 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

UCB PHARMA SACETIRIZINE HYDROCHLORIDE

DMF 68531987

UCB FARCHIM SACETIRIZINE HYDROCHLORIDE

DMF 175132004

MATRIX PHARMACORP PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 177412004

SOLARA ACTIVE PHARMA SCIENCES LTDCETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP

DMF 205392007

CALYX CHEMICALS AND PHARMACEUTICALS LTDCETIRIZINE HYDROCHLORIDE

DMF 213962008

CIMA LABORATORIES INCCETIRIZINE HYDROCHLORIDE COATED GRANULES

DMF 226802009

IPCA LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS)

DMF 260332012

UNICHEM LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP

DMF 280592014

THINQ PHARMA-CRO LTDCETIRIZINE HYDROCHLORIDE USP

DMF 288872015

GRANULES INDIA LTDCETIRIZINE HYDROCHLORIDE, USP

DMF 300632016

SUPRIYA LIFESCIENCE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 391992024

PRAVEEN LABORATORIES PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 435172026

IPCA LABORATORIES LTDInactiveCETIRIZINE HYDROCHLORIDE USP

DMF 209972007

IWAKI SEIYAKU CO LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 218642008

DISHMAN CARBOGEN AMCIS LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 261792012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2004	SUPPL -11	View Letter (PDF)
Oct 21, 2002	SUPPL -8	View Letter (PDF)
May 15, 1998	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 27, 1996

No patent or exclusivity listings for this strength.