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Generated: September 20, 2018

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CLARINEX D 24 HOUR Drug Profile

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Which patents cover Clarinex D 24 Hour, and what generic alternatives are available?

Clarinex D 24 Hour is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in CLARINEX D 24 HOUR 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.

US Patents and Regulatory Information for CLARINEX D 24 HOUR

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 D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for CLARINEX D 24 HOUR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for CLARINEX D 24 HOUR

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
6,709,676 Extended release oral dosage composition ➤ Try a Free Trial
8,187,630 Extended release oral dosage composition ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for CLARINEX D 24 HOUR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/013 Belgium ➤ Try a Free Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1/2008 Austria ➤ Try a Free Trial PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
C0004 France ➤ Try a Free Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
2008 00010 Denmark ➤ Try a Free Trial PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
C063/2007 Ireland ➤ Try a Free Trial SPC063/2007: 20081105, EXPIRES: 20220729
0328 Netherlands ➤ Try a Free Trial
C/GB08/005 United Kingdom ➤ Try a Free Trial SUPPLEMENTARY 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.
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Chinese Patent Office
Colorcon
Julphar
Fuji
Deloitte
Daiichi Sankyo
Express Scripts

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