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Last Updated: April 7, 2020

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CLARINEX-D 12 HOUR Drug Profile


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When do Clarinex-d 12 Hour patents expire, and when can generic versions of Clarinex-d 12 Hour launch?

Clarinex-d 12 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 sixty-three patent family members in thirty-seven countries.

The generic ingredient in CLARINEX-D 12 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 12 Hour

Clarinex-d 12 Hour was eligible for patent challenges on December 21, 2005.

There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for CLARINEX-D 12 HOUR
Recent Clinical Trials for CLARINEX-D 12 HOUR

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

See all CLARINEX-D 12 HOUR clinical trials

Recent Litigation for CLARINEX-D 12 HOUR

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-06
SCHERING CORPORATION v. SANDOZ INC.2008-04-03
Forest Laboratories Inc. v. Lupin Pharmaceuticals Inc.2008-01-10

See all CLARINEX-D 12 HOUR litigation

Synonyms for CLARINEX-D 12 HOUR
855790-99-7
Aerinaze
Clarinex-D
Clarinex-D 24 Hour
Desloratadine mixture with pseudoephedrine
Desloratadine/pseudoephedrine
DTXSID40234786
Pseudoephedrine mixture with Desloratadine
Paragraph IV (Patent) Challenges for CLARINEX-D 12 HOUR
Tradename Dosage Ingredient NDA Submissiondate
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2007-06-01
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2006-06-21

US Patents and Regulatory Information for CLARINEX-D 12 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 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Start Trial   Start Trial   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 12 HOUR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLARINEX-D 12 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0152897 C00152897/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543 122008000001 Germany   Start Trial PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 SPC063/2007 Ireland   Start Trial SPC063/2007: 20081105, EXPIRES: 20220729
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
McKinsey
Merck
Dow
Harvard Business School

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