CLOLAR Drug Patent Profile

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When do Clolar patents expire, and what generic alternatives are available?

Clolar is a drug marketed by Genzyme and is included in one NDA.

The generic ingredient in CLOLAR is clofarabine. Nine suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clolar

A generic version of CLOLAR was approved as clofarabine by AMNEAL on November 6^th, 2017.

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Summary for CLOLAR

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for CLOLAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLOLAR	Injection	clofarabine	1 mg/mL, 20 mL vial	021673	1	2012-02-23

US Patents and Regulatory Information for CLOLAR

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Glossary

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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	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for CLOLAR

See the table below for patents covering CLOLAR around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	1271192	2'-FLUORO-ARABINOFURANOSYLE PURINE NUCLEOSIDES (2'-FLUORO-ARABINOFURANOSYL PURINE NUCLEOSIDES)	⤷ Start Trial
Germany	122006000056		⤷ Start Trial
Germany	3687397		⤷ Start Trial
European Patent Office	0219829	2-FLUORO-ARABINOFURANOSYL PURINE NUCLEOSIDES	⤷ Start Trial
Japan	H0723395		⤷ Start Trial
Japan	S62161797	2'-FLUORO-ARABINOFRANOSYLPURINE NUCLEOTIDE	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CLOLAR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0219829	SPC/GB06/034	United Kingdom	⤷ Start Trial	PRODUCT 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
0473708	06C0038	France	⤷ Start Trial	PRODUCT 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
0473708	300247	Netherlands	⤷ Start Trial	300247, 20100523, EXPIRES: 20150522
0219829	06C0029	France	⤷ Start Trial	PRODUCT 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
0473708	SPC/GB06/040	United Kingdom	⤷ Start Trial	PRODUCT 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for CLOLAR

Paragraph IV (Patent) Challenges for CLOLAR

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