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Serving leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
Covington
Cantor Fitzgerald
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Boehringer Ingelheim
Teva
Federal Trade Commission
Moodys
Fish and Richardson

Generated: December 13, 2017

DrugPatentWatch Database Preview

Clofarabine - Generic Drug Details

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What are the generic drug sources for clofarabine and what is the scope of clofarabine patent protection?

Clofarabine
is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Amneal Pharms Co, Dr Reddys Labs Ltd, Mylan Labs Ltd, and Genzyme, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Pharmacology for clofarabine

Tentative approvals for CLOFARABINE

Applicant Application No. Strength Dosage Form
u► Subscribe20MG/20MLINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
GenzymeCLOLARclofarabineINJECTABLE;IV (INFUSION)021673-001Dec 28, 2004APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Amneal Pharms CoCLOFARABINEclofarabineINJECTABLE;IV (INFUSION)208857-001Nov 6, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdCLOFARABINEclofarabineINJECTABLE;IV (INFUSION)208860-001Nov 6, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdCLOFARABINEclofarabineINJECTABLE;IV (INFUSION)205375-001Nov 6, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Abon Pharms LlcCLOFARABINEclofarabineINJECTABLE;IV (INFUSION)204029-001May 9, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► 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
GenzymeCLOLARclofarabineINJECTABLE;IV (INFUSION)021673-001Dec 28, 2004► Subscribe► Subscribe
GenzymeCLOLARclofarabineINJECTABLE;IV (INFUSION)021673-001Dec 28, 2004► Subscribe► 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
5,034,518 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 Ingredient: clofarabine

Country Document Number Estimated Expiration
Netherlands300247► Subscribe
Australia5831590► Subscribe
Austria147751► Subscribe
Hong Kong1007561► Subscribe
World Intellectual Property Organization (WIPO)9014352► Subscribe
Germany122006000060► Subscribe
European Patent Office0595826► Subscribe
JapanH05502014► Subscribe
Japan3160288► Subscribe
European Patent Office0473708► 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
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
0247Netherlands► Subscribe300247, 20100523, EXPIRES: 20150522
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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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Queensland Health
UBS
Julphar
Chinese Patent Office
Medtronic
Merck
Mallinckrodt
Healthtrust

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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