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CLARINEX Drug Profile

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

This drug has thirty-one patent family members in twenty-eight 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 Tradename: CLARINEX

Patents:8
Applicants:1
NDAs:5
Suppliers / Packagers: see list2
Bulk Api Vendors: see list66
Clinical Trials: see list10
Patent Applications: see list3,439
Drug Prices:see details
DailyMed Link:CLARINEX at DailyMed

Pharmacology for Tradename: CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004RXYesYes6,514,520*PED► subscribeY► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET;ORAL021165-001Dec 21, 2001RXYesYes7,405,223*PED► subscribeY► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 2002RXYesYes6,100,274*PED► subscribeY► subscribe
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Expired Patents for Tradename: CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 20024,863,931*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-002Jul 14, 20054,659,716*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET;ORAL021165-001Dec 21, 20017,214,683*PED► subscribe
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Paragraph IV activity for: CLARINEX

Drugname Dosage Strength RLD Submissiondate
desloratadineOral Solution0.5 mg/mLClarinex Syrup5/8/2008
desloratadineTablets5 mgClarinex6/21/2006
desloratadine and pseudoephedrine sulfateExtended-release Tablets5mg/240mgClarinex-D 24 Hour6/21/2006
desloratadineOrally Disintegrating Tablets2.5 mg and 5 mgClarinex6/21/2006

Non-Orange Book Patents for Tradename: 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
6,132,758 Stabilized antihistamine syrup► subscribe
6,939,550 Stabilized antihistamine syrup► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CLARINEX

Country Document Number Estimated Expiration
Gulf Cooperation Council0000330► subscribe
European Patent Office1082117► subscribe
Japan2002516860► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CLARINEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/012United Kingdom► subscribePRODUCT 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
C0004France► subscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
01C/013Belgium► subscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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