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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4918 Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client 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 the listed reference drug being CLARINEX RediTabs 2.5 mg (ND	Suitability	2026-05-06	Open	Lachman Consulting Services

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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