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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 eight patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and five patent family members in forty-seven countries.

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

Summary for CLARINEX

International Patents:	105
US Patents:	4
Applicants:	1
NDAs:	5
Suppliers / Packagers:	1
Bulk Api Vendors:	83
Clinical Trials:	17
Patent Applications:	3,509
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARINEX
DailyMed Link:	CLARINEX at DailyMed

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

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 (TN)

Clarinex RediTabs

Clarinex(R)

CPD000149358

CS-2639

CTK8B3353

D01GBY

D03693

D3787

DB00967

delopedil

Denosin

Desalex

Descarboethoxyloratadine

descarboethoxyloratidine

Descarboethoxyoratidine

Desloratadine

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

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					Y
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

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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	021312-002	Jul 14, 2005
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001

Paragraph IV (Patent) Challenges for CLARINEX

Drugname	Dosage	Strength	RLD	Submissiondate
	Oral Solution	0.5 mg/mL		2008-05-08
	Tablets	5 mg		2006-06-21
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21
	Extended-release Tablets	5mg/240mg		2006-06-21

Non-Orange Book US Patents for CLARINEX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,902,208	Treating allergic and inflammatory conditions
6,132,758	Stabilized antihistamine syrup
8,187,630	Extended release oral dosage composition
6,709,676	Extended release oral dosage composition

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International Patents for CLARINEX

Country	Document Number	Estimated Expiration
Norway	20006503
Netherlands	300328
Portugal	1110543
Japan	2005015485

Supplementary Protection Certificates for CLARINEX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
01C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115