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. Eleven 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.
Summary for CLOLAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 66 |
| Patent Applications: | 5,301 |
| Drug Prices: | Drug price information for CLOLAR |
| What excipients (inactive ingredients) are in CLOLAR? | CLOLAR excipients list |
| DailyMed Link: | CLOLAR at DailyMed |
Recent Clinical Trials for CLOLAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlycoMimetics Incorporated | Phase 1/Phase 2 |
| John Horan, MD | Phase 1/Phase 2 |
| Medexus Pharma, Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Genzyme | CLOLAR | clofarabine | SOLUTION;INTRAVENOUS | 021673-001 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | |
| Sanofi B.V. | 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 |
International Patents for CLOLAR
See the table below for patents covering CLOLAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 5831590 | ⤷ Try a Trial | |
| Netherlands | 300247 | ⤷ Try a Trial | |
| Japan | H05502014 | ⤷ Try a Trial | |
| Austria | 147751 | ⤷ Try a Trial | |
| European Patent Office | 0595826 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLOLAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0219829 | SPC/GB06/034 | United Kingdom | ⤷ Try a 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 | ⤷ Try a Trial | 300247, 20100523, EXPIRES: 20150522 |
| 0473708 | 06C0038 | France | ⤷ Try a 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 |
| 0219829 | 06C0029 | France | ⤷ Try a 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 | ⤷ Try a 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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 verification 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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