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CLARINEX

NDA

DESLORATADINE | N021312 | ORGANON LLC A SUB OF ORGANON AND CO

2 strengths0 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4918 · 7 docket documents Lachman Consulting Services, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Desloratadine Tablets, 2.5 mg suitable for submission as an ANDA, with CLARINEX RediTabs 2.5 mg (NDA #021312) as the reference drug, based on a proposed	Suitability	2026-05-06	Open	Lachman Consulting Services, Inc.
Citizens Petition from WellPoint Health Networks FDA-2002-P-0519 · 5 docket documents WellPoint Health Networks, filed by Chief Pharmacy Officer Robert Seidman, submitted this citizen petition under 21 CFR 10.30 requesting that the FDA exempt desloratadine (Clarinex) from prescription-only requirements and approve it for over-the-counter status, arguing that desloratadine has a safet	Other	2013-03-12	Withdrawn	WellPoint Health Networks

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

Clinical Trials

58 trials from ClinicalTrials.gov, 53 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
Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)NCT00598611	Phase 3	Completed	Charite University, Berlin, Germany	29	2007-09 → 2009-08
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
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)NCT00805324	Phase 3	Completed	Organon and Co	54	2003-05 → 2003-08
Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Desloratadine)(P03442)NCT00805584	Phase 4	Completed	Organon and Co	311	2003-05 → 2003-06
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine NCT01108783	Phase 3	Completed	Faes Farma, S.A.	720	2003-04 → 2004-02
A Study of the Effects of Desloratadine on Conjunctival Allergen Challenge-induced Ocular Signs and Symptoms (Study P04209)NCT00311844	Phase 4	Completed	Organon and Co	41	2005-03-01 → 2005-05-28
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria NCT01940393	Phase 4	Completed	Grupo de Alergología Clínica y Experimental	150	2013-08 → 2014-01
Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284)NCT00779636	Phase 4	Completed	Organon and Co	506	2003-07-01 → 2004-11-01
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03182)NCT00794599	Phase 4	Completed	Organon and Co	118	2002-12 → 2003-08

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

API Supply Chain10 active DMFs6 inactive

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

MOREPEN LABORATORIES LTDDESLORATADINE

DMF 176522004

SUN PHARMACEUTICAL INDUSTRIES LTDDESLORATADINE

DMF 190142005

LUPIN LTDDESLORATADINE USP

DMF 190832005

ORBION PHARMACEUTICALS PRIVATE LTDDESLORATADINE

DMF 193392006

ALIVUS LIFE SCIENCES LTDDESLORATADINE

DMF 194282006

DR REDDYS LABORATORIES LTDDESLORATADINE USP

DMF 194562006

CADILA PHARMACEUTICALS LTDDESLORATADINE

DMF 211332007

MATRIX PHARMACORP PRIVATE LTDDESLORATADINE USP

DMF 211872007

TARO PHARMACEUTICAL INDUSTRIES LTDDESLORATADINE

DMF 242752010

VASUDHA PHARMA CHEM LTDDESLORATADINE USP

DMF 288252014

CIPLA LTDInactiveDESLORATADINE

DMF 191822006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDESLORATADINE DRUG SUBSTANCE

DMF 194032006

DIVIS LABORATORIES LTDInactiveDESLORATADINE

DMF 194412006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDESLORATADINE DRUG SUBSTANCE

DMF 195082006

CIPLA LTDInactiveDESLORATADINE FORM I: FORM II (89:11)

DMF 223122009

HAINAN POLY PHARMACEUTICAL CO LTDInactiveDESLORATADINE

DMF 239262010

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2019	SUPPL -20	View Letter (PDF)
Mar 5, 2019	SUPPL -18	View Letter (PDF)
Apr 24, 2014	SUPPL -15	View Letter (PDF)
Dec 28, 2010	SUPPL -11	View Letter (PDF)
Dec 28, 2006	SUPPL -9	View Letter (PDF)
Dec 28, 2006	SUPPL -6	View Letter (PDF)
Dec 28, 2006	SUPPL -8	View Letter (PDF)
Jul 21, 2005	SUPPL -7	View Letter (PDF)
Jun 1, 2004	SUPPL -2	View Letter (PDF)
Feb 3, 2004	SUPPL -4	View Letter (PDF)
Jun 26, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

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

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 26, 2002

No patent or exclusivity listings for this strength.

#002 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jul 14, 2005