Viewing data from:

XYZAL ALLERGY 24HR

NDA

LEVOCETIRIZINE DIHYDROCHLORIDE | N209089 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
UCB, Inc. - Citizen Petition FDA-2010-P-0545 · 5 docket documents UCB, Inc., the manufacturer of Xyzal (levocetirizine dihydrochloride), filed this petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA not approve any ANDA for levocetirizine where the generic's labeling omits or obscures safety information related to allergi	505(q)	2010-11-05	Denied	—

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

Clinical Trials

59 trials from ClinicalTrials.gov, 56 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)NCT00359138	Phase 4	Completed	Organon and Co	36	2006-02 → 2006-05
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)NCT00160680	Phase 4	Completed	UCB S.A. - Pharma Sector	62	2005-03-01 → 2006-06-01
Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis NCT00439712	Phase 4	Completed	Institut für Atemwegsforschung GmbH	60	2007-02 → 2007-05
Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen NCT00315523	Phase 3	Completed	UCB Pharma	403	2006-07 → 2006-10
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites NCT00521131	Phase 4	Completed	UCB Pharma	453	2002-09 → 2003-05
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis NCT00679250	Phase 4	Completed	Brian J Lipworth	25	2005-11 → 2006-12
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition NCT01557439	Phase 1	Completed	IPCA Laboratories Ltd.	28	2012-02 → 2012-03
POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)NCT00160537	Phase 4	Completed	UCB Pharma	200	2005-05 → 2005-07
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)NCT00789152	Phase 3	Completed	Organon and Co	81	2003-12-01 → 2004-05-01
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis NCT00525278	Phase 3	Completed	UCB Pharma	67	2003-08 → 2003-10

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

API Supply Chain11 active DMFs2 inactive

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

CIPLA LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 201732007

GLOCHEM INDUSTRIES PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 211102007

SUN PHARMACEUTICAL INDUSTRIES LTDLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 212142008

COHANCE LIFESCIENCES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 214172008

SYMED LABS LTDLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 222862008

ALIVUS LIFE SCIENCES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 226772009

GRANULES INDIA LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 228982009

TARO PHARMACEUTICAL INDUSTRIES LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 243432010

JUBILANT BIOSYS LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 252792012

CHROMO LABORATORIES INDIA PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 332192019

METROCHEM API PRIVATE LTDLEVOCETIRIZINE DIHYDROCHLORIDE USP

DMF 347312020

WAVELENGTH ENTERPRISES LTDInactiveLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 241612010

SYNTHON BVInactiveLEVOCETIRIZINE DIHYDROCHLORIDE

DMF 245612011

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 21, 2026	SUPPL -10	View Letter (PDF)
Jul 15, 2024	SUPPL -7	View Letter (PDF)
Jan 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 31, 2017

No patent or exclusivity listings for this strength.