Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

CLARINEX-D 12 HOUR Drug Profile

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Which patents cover Clarinex-d 12 Hour, and what generic alternatives are available?

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.

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

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

SponsorPhase
UCB PharmaPhase 4
Derm Research, PLLCPhase 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 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 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
>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
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 C 2008 001 Romania   Start Trial PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
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
0152897 2001C/013 Belgium   Start Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1110543 91403 Luxembourg   Start Trial 91403, EXPIRES: 20220730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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