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Last Updated: July 6, 2020

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CLOLAR Drug Profile


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Which patents cover Clolar, and when can generic versions of Clolar launch?

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

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

US ANDA Litigation and Generic Entry Outlook for Clolar

A generic version of CLOLAR was approved as clofarabine by ABON PHARMS LLC on May 9th, 2017.

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Drug patent expirations by year for CLOLAR
Drug Prices for CLOLAR

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Recent Clinical Trials for CLOLAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Milton S. Hershey Medical CenterPhase 2
Mesoblast, Inc.Phase 2
St. Baldrick's FoundationPhase 2

See all CLOLAR clinical trials

Pharmacology for CLOLAR
Paragraph IV (Patent) Challenges for CLOLAR
Tradename Dosage Ingredient NDA Submissiondate
CLOLAR SOLUTION;INTRAVENOUS clofarabine 021673 2012-02-23

US Patents and Regulatory Information for 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 SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 AP RX Yes Yes   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

Expired US Patents for CLOLAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004   Start Trial   Start Trial
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004   Start Trial   Start Trial
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLOLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Dow
Express Scripts
Medtronic
Mallinckrodt

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