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Clofarabine - Generic Drug Details

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Clofarabine is the generic ingredient in one branded drug marketed by Genzyme and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifteen patent family members in ten countries.

There are eleven drug master file entries for clofarabine. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: clofarabine

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packaging: see list2
Drug Prices:see low prices

Pharmacology for Ingredient: clofarabine

Tentative approvals for CLOFARABINE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION20MG/20ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 2004RXYes5,661,136*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: clofarabine

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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Non-Orange Book Patents for Generic Ingredient: clofarabine

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

Country Document Number Estimated Expiration
Hong Kong1007561► subscribe
World Intellectual Property Organization (WIPO)9014352► subscribe
Germany69029733► 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: CLOFARABINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0247Netherlands► subscribe300247, 20100523, EXPIRES: 20150522
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
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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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