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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
QuintilesIMS
Julphar
Daiichi Sankyo
Novartis
McKinsey
Merck
AstraZeneca
Citi

Generated: December 17, 2017

DrugPatentWatch Database Preview

CLOLAR Drug Profile

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When do Clolar patents expire, and when can generic versions of Clolar launch?

Clolar is a drug marketed by Genzyme and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in ten countries and five supplementary protection certificates in three countries.

The generic ingredient in CLOLAR is clofarabine. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Drug patent expirations by year for CLOLAR

Pharmacology for CLOLAR

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
GenzymeCLOLARclofarabineINJECTABLE;IV (INFUSION)021673-001Dec 28, 2004APRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for CLOLAR

Drugname Dosage Strength RLD Submissiondate
clofarabineInjection1 mg/mL, 20 mL vialClolar2/23/2012

Non-Orange Book Patents for Tradename: CLOLAR

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
5,034,518 2-fluoro-9-(2-deoxy-2-fluoro-.beta.-D-arabinofuranosyl) adenine nucleosides► Subscribe
5,384,310 2'-fluoro-2-haloarabinoadinosines and their pharmaceutical compositions► 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 Tradename: CLOLAR

Country Document Number Estimated Expiration
Netherlands300247► Subscribe
World Intellectual Property Organization (WIPO)9014352► Subscribe
European Patent Office0595826► Subscribe
JapanH05502014► Subscribe
Germany122006000060► Subscribe
European Patent Office0473708► Subscribe
Australia5831590► Subscribe
Spain2098266► Subscribe
Germany69029733► Subscribe
JapanH06507644► 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: CLOLAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/040United Kingdom► SubscribePRODUCT NAME: THE USE OF CLOFARABINE (2-CHLORO-9-(2-DEOXY-2-FLUORO-SS-D-ARABINOFURANOSYL)-ADENINE) FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
C/GB06/034United Kingdom► SubscribePRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
C0038France► SubscribePRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529
C0029France► SubscribePRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529
0247Netherlands► Subscribe300247, 20100523, EXPIRES: 20150522
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
Chubb
Julphar
Citi
US Army
Deloitte
Merck
Johnson and Johnson
Novartis

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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