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Serving leading biopharmaceutical companies globally:

UBS
Covington
McKinsey
US Army
Federal Trade Commission
Merck
Queensland Health
Daiichi Sankyo
AstraZeneca
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Generated: December 12, 2017

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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-four patent family members in thirty-seven countries and eleven supplementary protection certificates in ten countries.

The generic ingredient in CLARINEX-D 12 HOUR is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: CLARINEX-D 12 HOUR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
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International Patent Family for Tradename: CLARINEX-D 12 HOUR

Country Document Number Estimated Expiration
Germany60028710► Subscribe
Saudi Arabia2362► Subscribe
Luxembourg91403► Subscribe
EcuadorSP003835► Subscribe
South Africa200007714► Subscribe
Cyprus1109636► Subscribe
Slovenia1674084► Subscribe
SloveniaEP1110543► Subscribe
Japan2001206846► Subscribe
Denmark1110543► 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: CLARINEX-D 12 HOUR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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.
2008 00010Denmark► Subscribe
01C/013Belgium► SubscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0328Netherlands► Subscribe
403Luxembourg► Subscribe91403, EXPIRES: 20220730
C063/2007Ireland► SubscribeSPC063/2007: 20081105, EXPIRES: 20220729
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
8Finland► Subscribe
1/2008Austria► SubscribePRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
C0004France► SubscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
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Serving leading biopharmaceutical companies globally:

US Army
Accenture
Julphar
Healthtrust
Novartis
Queensland Health
Farmers Insurance
Deloitte
Moodys
Boehringer Ingelheim

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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