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CLARINEX Drug Profile

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Which patents cover Clarinex, and what generic alternatives are available?

Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-three patent family members in thirty-seven countries.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for CLARINEX

International Patents:	73
US Patents:	3
Applicants:	1
NDAs:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	98
Clinical Trials:	17
Patent Applications:	3,981
Drug Prices:	Drug price information for CLARINEX
Drug Sales Revenues:	Drug sales revenues for CLARINEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARINEX
DailyMed Link:	CLARINEX at DailyMed

See drug prices for CLARINEX

See drug sales revenues for CLARINEX

Recent Clinical Trials for CLARINEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Derm Research, PLLC	Phase 4
UCB Pharma	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all CLARINEX clinical trials

Recent Litigation for CLARINEX

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.	2015-08-06
Purdue Pharmaceutical v. Actavis Elizabeth LLC	2015-05-13
Simonian v. Merck & Co., Inc.	2010-02-25

See all CLARINEX litigation

Pharmacology for CLARINEX

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

Synonyms for CLARINEX

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

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

AK163520

AKOS000280921

ALBB-027276

Allex

AN-15105

ANW-42359

API0002262

Azomyr

BBL010777

BC205533

BCP02340

BDBM50073179

BEN691

BG0513

BRD-K82357231-001-13-4

C-19255

C19H19ClN2

CAS-100643-71-8

CC-26349

CCG-101162

CD0143

CHEBI:291342

CHEMBL1172

Claramax

Clarinex (TN)

Clarinex RediTabs

Clarinex(R)

CPD000149358

CS-2639

CTK8B3353

D03693

D3787

DB00967

Denosin

Desalex

Descarboethoxyloratadine

Descarboethoxyoratidine

Desloratadine

Desloratadine (JAN/USAN/INN)

Desloratadine [USAN:INN:BAN]

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

Desloratidine, Pharmaceutical Secondary Standard; Certified Reference Material

DSSTox_CID_24196

DSSTox_GSID_44196

DSSTox_RID_80112

DTXSID1044196

FT-0602522

FVF865388R

GTPL7157

HMS2052H05

HMS2090C06

HMS2093F19

HMS3394H05

HMS3652O15

HMS3715J15

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

MK-4117

MLS000559042

MLS000759406

MLS001201801

MLS001424247

MolPort-000-883-875

NC00412

NCGC00159325-02

NCGC00159325-03

NCGC00159325-04

NCGC00159325-05

Neoclarityn

NSC-675447

NSC-759824

NSC675447

NSC759824

Opera_ID_1891

Opulis

Pharmakon1600-01505393

Q-200936

R3930

RT-012269

s4012

SAM001246545

SB17503

SBI-0206828.P001

SC-17296

Sch 34117

Sch-34117

SCHEMBL4425

SMR000149358

SR-01000668962

SR-01000668962-4

SR-01000668962-5

SR-01000668962-8

ST24046429

STK586537

SW197792-3

TL8000065

Tox21_111574

Tox21_111574_1

UNII-FVF865388R

ZINC1261

ZX-AN025785

Paragraph IV (Patent) Challenges for CLARINEX

Tradename	Dosage	Ingredient	NDA	Submissiondate
CLARINEX	SOLUTION;ORAL	desloratadine	021300	2008-05-08
CLARINEX	TABLET;ORAL	desloratadine	021165	2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	AA	RX	Yes	Yes
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes					Y
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	AB	RX	Yes	Yes					Y
Merck Sharp Dohme	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes			Y
Merck Sharp Dohme	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	AB	RX	Yes	Yes			Y
Merck Sharp Dohme	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes					Y

Expired US Patents for CLARINEX

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, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002

International Patents for CLARINEX

Country	Patent Number	Estimated Expiration
Ecuador	SP003835
China	101134038
South Africa	200007714
China	1302605
Japan	2008110989
Slovenia	1674084

Supplementary Protection Certificates for CLARINEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	318	Finland
1110543	300328	Netherlands
1110543	122008000001	Germany		PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	1/2008	Austria		PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	C 2008 001	Romania		PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730