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Last Updated: November 23, 2020

DrugPatentWatch Database Preview

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.

This drug has one hundred and twenty-one patent family members in thirty-nine countries.

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 ANDA Litigation and Generic Entry Outlook for Clarinex D 24 Hour

Clarinex D 24 Hour was eligible for patent challenges on December 21, 2005.

Indicators of Generic Entry

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Summary for CLARINEX D 24 HOUR
International Patents:121
US Patents:4
Applicants:1
NDAs:1
Clinical Trials: 17
Formulation / Manufacturing:see details
DailyMed Link:CLARINEX D 24 HOUR at DailyMed
Drug patent expirations by year for CLARINEX D 24 HOUR
Recent Clinical Trials for CLARINEX D 24 HOUR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Derm Research, PLLCPhase 4
UCB PharmaPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all CLARINEX D 24 HOUR clinical trials

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

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

Supplementary Protection Certificates for CLARINEX D 24 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 318 Finland   Start Trial
0152897 SPC/GB01/012 United Kingdom   Start Trial 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
0152897 2001C/013 Belgium   Start Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1110543 SZ 1/2008 Austria   Start Trial PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
1110543 300328 Netherlands   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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