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Last Updated: February 28, 2020

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DESLORATADINE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details

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What are the generic sources for desloratadine; pseudoephedrine sulfate and what is the scope of freedom to operate?

Desloratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Merck Sharp Dohme and Dr Reddys Labs Ltd, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desloratadine; pseudoephedrine sulfate has one hundred and twenty-one patent family members in thirty-nine countries.

There are sixteen drug master file entries for desloratadine; pseudoephedrine sulfate. One supplier is listed for this compound.

Summary for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Recent Clinical Trials for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

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Recent Litigation for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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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

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Pharmacology for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Paragraph IV (Patent) Challenges for DESLORATADINE; PSEUDOEPHEDRINE SULFATE
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 DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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 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 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 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
>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 DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Supplementary Protection Certificates for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 SPC/GB08/005 United Kingdom   Start 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.
1110543 CA 2008 00010 Denmark   Start Trial PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
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 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 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; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 318 Finland   Start Trial
1110543 08C0004 France   Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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