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Desloratadine; pseudoephedrine sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for desloratadine; pseudoephedrine sulfate?

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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: desloratadine; pseudoephedrine sulfate

Tradenames:3
Patents:7
Applicants:2
NDAs:3
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Clinical Trials: see list305
Drug Prices:see low prices
DailyMed Link:desloratadine; pseudoephedrine sulfate at DailyMed

Pharmacology for Ingredient: desloratadine; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date 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, 2011RXNoNo► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005RXYesYes6,979,463► SubscribeY ► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes7,618,649*PED► SubscribeY► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes8,187,630► SubscribeY ► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005RXYesYes7,820,199*PED► 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 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 20054,659,716*PED► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 20064,659,716*PED► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 20067,214,684*PED► Subscribe
Merck Sharp Dohme
CLARINEX-D 12 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 20067,214,683*PED► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 20057,214,683*PED► Subscribe
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International Patent Family for Ingredient: desloratadine; pseudoephedrine sulfate

Country Document Number Estimated Expiration
Peru09522001► Subscribe
Netherlands300328► Subscribe
Cyprus1110693► Subscribe
Australia2005203771► Subscribe
Japan5158919► 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
01C/013Belgium► SubscribePRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
403Luxembourg► Subscribe91403, EXPIRES: 20220730
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
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.
C063/2007Ireland► SubscribeSPC063/2007: 20081105, EXPIRES: 20220729
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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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