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Generated: May 24, 2019

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DESLORATADINE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details

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What are the generic drug sources for desloratadine; pseudoephedrine sulfate and what is the scope of desloratadine; pseudoephedrine sulfate 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 nineteen 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
Pharmacology for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 DESLORATADINE; PSEUDOEPHEDRINE SULFATE

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 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 1/2008 Austria ➤ Sign Up 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 SPC/GB08/005 United Kingdom ➤ Sign Up 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 SZ 1/2008 Austria ➤ Sign Up PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
1110543 318 Finland ➤ Sign Up
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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