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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 nine 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:9
Applicants:1
NDAs:5
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004RXYes6,514,520*PED► subscribeY► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 2002RXYes7,618,649*PED► subscribeY► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-002Jul 14, 2005RXNo7,618,649*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, 20024,804,666*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET;ORAL021165-001Dec 21, 20015,595,997*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
Denmark1082117► subscribe
Austria257705► subscribe
Panama8474201► 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/GB08/005United Kingdom► subscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
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
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