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CLARINEX Drug Profile

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When do Clarinex patents expire, and when can generic versions of Clarinex launch?

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

This drug has sixty-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.

DrugPatentWatch^® Generic Entry Outlook for Clarinex

Clarinex was eligible for patent challenges on December 21, 2005.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for CLARINEX

International Patents:	63
US Patents:	1
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	17
Patent Applications:	3,982
Drug Prices:	Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?	CLARINEX excipients list
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

Pharmacology for CLARINEX

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

ATC Classes for CLARINEX

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

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		DISCN	Yes	No
Merck Sharp Dohme	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No					Y
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes
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	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Merck Sharp Dohme	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No

Expired US Patents for CLARINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004
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	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	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005

International Patents for CLARINEX

Country	Patent Number	Estimated Expiration
Denmark	1674084
World Intellectual Property Organization (WIPO)	8503707
Slovakia	287105
Denmark	163059
Japan	2008081509
Canada	2333528

Supplementary Protection Certificates for CLARINEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543	318	Finland
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	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
1110543	CA 2008 00010	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT