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Desloratadine - Generic Drug Details

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What are the generic drug sources for desloratadine and what is the scope of desloratadine freedom to operate?

Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro Pharm, Taro Pharm Inds Ltd, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orchid Hlthcare, Perrigo R And D, Sandoz, and Sun Pharm Inds, and is included in seventeen NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desloratadine. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for desloratadine

US Patents:	8
Tradenames:	5
Applicants:	12
NDAs:	17
Drug Master File Entries:	16
Suppliers / Packagers:	12
Bulk Api Vendors:	85
Clinical Trials:	62
Patent Applications:	5,724
Drug Prices:	Drug price information for desloratadine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for desloratadine
DailyMed Link:	desloratadine at DailyMed

Pharmacology for desloratadine

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Synonyms for desloratadine

100643-71-8

13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3,5,7,12,14-hexaene

13-CHLORO-2-(PIPERIDIN-4-YLIDENE)-4-AZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3,5,7,11,13-HEXAENE

4-(8-chloro-5,6-dihydro-11 H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

4-(8-chloro-5,6-dihydro-11H-benzo-[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-ylidene) piperidine

4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta(1,2-b]pyridin-11-ylidene)-piperidine

4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) piperidine

4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)piperidine

4-{8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}-piperidine

4-{8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene}piperidine

5H-Benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

5H-Benzo(5,6)cyclohepta(1,2-b)pyridine,8-chloro-6,11-dihydro-11-(4-piperidinyllidene)-

5H-Benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-

643D718

8-chloro-11-(4-piperidyliden)-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridine

8-chloro-11-(4-piperidyliden)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

8-CHLORO-11-(4-PIPERIDYLIDENE)-6,11-DIHYDRO-5H-BENZO[5,6]CYCLOHEPTA[1,2-b]PYRIDINE

8-chloro-11-(4-piperidylidene)-6,11-dihydro-5h-benzo[5.6]cyclohepta[1,2-b]pyridine

8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Descarboethoxyloratadine; Desloratadine)

8-chloro-11-piperidin-4-ylidene-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridine

8-Chloro-11-piperidin-4-ylidene-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5h-benzo[5,6]cyclohepta[1,2-b]pyridine

8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H- benzo[5,6]cyclohepta[1,2,b]pyridine

8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine

8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

A19515

AB0012600

AB00456701_14

AB00456701_15

AB00456701-11

AB00456701-13

AC-1279

AC1L3XUD

Aerius

Aerius (TN)

AK163520

AKOS000280921

ALBB-027276

Allex

AN-15105

ANW-42359

API0002262

Azomyr

BB_SC-2104

BBL010777

BC205533

BDBM50073179

BEN691

BG0513

C-19255

C19H19ClN2

CAS-100643-71-8

CC-26349

CCG-101162

CD0143

CHEBI:291342

CHEMBL1172

Claramax

Claramax (TN)

Clarinex

Clarinex (TN)

Clarinex RediTabs

Clarinex(R)

CPD000149358

CS-2639

CTK8B3353

D01GBY

D03693

D3787

DB00967

delopedil

Denosin

Desalex

Descarboethoxyloratadine

descarboethoxyloratidine

Descarboethoxyoratidine

Desloratadine (JAN/USAN/INN)

Desloratadine (USAN/INN)

Desloratadine [USAN]

Desloratadine for system suitability, European Pharmacopoeia (EP) Reference Standard

Desloratadine, European Pharmacopoeia (EP) Reference Standard

Desloratadine, powder, >=98% (HPLC)

Desloratadine, United States Pharmacopeia (USP) Reference Standard

Desloratidine

DR001310

DSSTox_CID_24196

DSSTox_GSID_44196

DSSTox_RID_80112

DTXSID1044196

Essex brand of desloratadine

FT-0602522

FVF865388R

GTPL7157

HMS2052H05

HMS2090C06

HMS2093F19

HMS3394H05

HMS3652O15

HY-B0539

I06-1866

J10309

JAUOIFJMECXRGI-UHFFFAOYSA-N

KS-00000G0C

KS-1048

L001025

Loratadine Related Compound A, United States Pharmacopeia (USP) Reference Standard

LS-181814

MCULE-2975958622

MFCD00871949

MLS000559042

MLS000759406

MLS001201801

MLS001424247

MolPort-000-883-875

NC00412

NCGC00159325-02

NCGC00159325-03

NCGC00159325-04

NCGC00159325-05

Neoclarityn

NeoClarityn (TN)

NSC-675447

NSC-759824

NSC675447

NSC759824

Opera_ID_1891

Opulis

Pharmakon1600-01505393

PL039437

Q-200936

R3930

RT-012269

s4012

SAM001246545

SBI-0206828.P001

SC-17296

Sch 34117

Sch-34117

SCHEMBL4425

Schering brand of desloratadine

Schering-Plough brand of desloratadine

SMR000149358

ST24046429

STK586537

TL8000065

Tox21_111574

Tox21_111574_1

UNII-FVF865388R

ZINC1261

ZX-AN025785

Tentative approvals for DESLORATADINE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		5MG	TABLET; ORAL

US Patents and Regulatory Information for desloratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orchid Hlthcare	DESLORATADINE	desloratadine	TABLET;ORAL	078357-001	Feb 19, 2010	AB	RX	No	No
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	AB	RX	Yes	No					Y
Merck Sharp Dohme	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes			Y

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Expired US Patents for desloratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004

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International Patents for desloratadine

Country	Document Number	Estimated Expiration
Malaysia	128658
Germany	60042904
Japan	2008081509

Supplementary Protection Certificates for desloratadine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C063/2007	Ireland		SPC063/2007: 20081105, EXPIRES: 20220729
2008000001	Germany		PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
C/GB01/012	United Kingdom		PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115