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Serving leading biopharmaceutical companies globally:

Merck
Argus Health
Daiichi Sankyo
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AstraZeneca
Fish and Richardson
Covington
Farmers Insurance
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Generated: November 22, 2017

DrugPatentWatch Database Preview

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 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 twenty-one patent family members in thirty-nine countries and eleven supplementary protection certificates in ten countries.

There are sixteen drug master file entries for desloratadine; pseudoephedrine sulfate. Two suppliers are listed for this compound.

Summary for desloratadine; pseudoephedrine sulfate

Pharmacology 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
Dr Reddys Labs Ltd
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL078366-001Apr 26, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: desloratadine; pseudoephedrine sulfate

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;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
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International Patent Family for Ingredient: desloratadine; pseudoephedrine sulfate

Country Document Number Estimated Expiration
Peru09822001► Subscribe
China100415223► Subscribe
Russian Federation2007104095► Subscribe
Japan2001206846► Subscribe
New Zealand509028► Subscribe
Luxembourg91403► Subscribe
Singapore149667► Subscribe
Japan2008081509► Subscribe
Denmark1112738► Subscribe
Hong Kong1034453► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008000001Germany► SubscribePRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
01C/013Belgium► SubscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
C/GB08/005United Kingdom► SubscribeSUPPLEMENTARY 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.
2008Austria► SubscribePRODUCT 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
2008 00010Denmark► Subscribe
0328Netherlands► Subscribe
C063/2007Ireland► SubscribeSPC063/2007: 20081105, EXPIRES: 20220729
403Luxembourg► Subscribe91403, EXPIRES: 20220730
8Finland► Subscribe
C0004France► SubscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
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Serving leading biopharmaceutical companies globally:

McKesson
UBS
Citi
Deloitte
Federal Trade Commission
Dow
Chinese Patent Office
AstraZeneca
Express Scripts
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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