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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
McKesson
QuintilesIMS
Chinese Patent Office
Cerilliant
Moodys
Covington
Julphar
Merck
Daiichi Sankyo

Generated: June 28, 2017

DrugPatentWatch Database Preview

CLOLAR Drug Profile

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What is the patent landscape for Clolar, 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.

The generic ingredient in CLOLAR is clofarabine. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

Summary for Tradename: CLOLAR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list62
Clinical Trials: see list55
Patent Applications: see list2,855
Drug Prices:see details
DailyMed Link:CLOLAR at DailyMed

Pharmacology for Tradename: CLOLAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 2004APRXYesYes5,661,136*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: CLOLAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 20044,918,179► Subscribe
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 20045,384,310► Subscribe
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Paragraph IV activity 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
Canada2102782► Subscribe
Japan3160288► Subscribe
European Patent Office0473708► Subscribe
Germany122006000060► 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
0247Netherlands► Subscribe300247, 20100523, EXPIRES: 20150522
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
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
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Novartis
Chinese Patent Office
Accenture
Cantor Fitzgerald
Baxter
QuintilesIMS
Boehringer Ingelheim
Medtronic
Covington

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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