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Desloratadine - Generic Drug Details

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Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Mylan Pharms Inc, Lupin Pharms, Belcher Pharms, Orchid Hlthcare, Sun Pharm Inds, Perrigo R And D, Sandoz, Dr Reddys Labs Ltd, Reddys, and Taro Pharm Inds, and is included in seventeen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in twenty-eight countries.

There are sixteen drug master file entries for desloratadine. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: desloratadine

Tradenames:5
Patents:9
Applicants:12
NDAs:17
Drug Master File Entries: see list16
Suppliers / Packaging: see list14
Therapeutic Class:Respiratory Tract Agents
Drug Prices:see low prices

Pharmacology for Ingredient: desloratadine

Tentative approvals for DESLORATADINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005RXYes7,820,199*PED► subscribeY► subscribe
Belcher Pharms
DESLORATADINE
desloratadine
TABLET;ORAL078355-001Apr 19, 2012RXNo► subscribe► subscribe
Sun Pharm Inds
DESLORATADINE
desloratadine
TABLET;ORAL078359-001Nov 16, 2010RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: desloratadine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 20025,595,997*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 20027,214,684*PED► subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET;ORAL021165-001Dec 21, 20014,804,666*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: desloratadine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,939,550 Stabilized antihistamine syrup► subscribe
6,132,758 Stabilized antihistamine syrup► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: desloratadine

Country Document Number Estimated Expiration
Egypt23908► subscribe
Australia754469► subscribe
Netherlands1012191► 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

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.
C/GB01/012United Kingdom► subscribePRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
C0004France► subscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
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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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