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Last Updated: October 1, 2022

CLOLAR Drug Patent 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. 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 ABON PHARMS LLC on May 9th, 2017.

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Summary for CLOLAR
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
Medexus Pharma, Inc.Phase 2
Memorial Sloan Kettering Cancer CenterPhase 2
Milton S. Hershey Medical CenterPhase 2

See all CLOLAR clinical trials

Pharmacology for CLOLAR
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

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

EU/EMA Drug Approvals for CLOLAR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ORPHELIA Pharma SAS Ivozall clofarabine EMEA/H/C/005039
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.
Authorised yes no no 2019-11-14
Genzyme Europe BV Evoltra clofarabine EMEA/H/C/000613
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.,
Authorised no no no 2006-05-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for CLOLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0219829 SPC/GB06/034 United Kingdom See Plans and Pricing 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
0219829 06C0029 France See Plans and Pricing 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 See Plans and Pricing 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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