Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Julphar
Medtronic
US Department of Justice
Cipla
US Army
Johnson and Johnson
Deloitte
Merck

Generated: August 18, 2018

DrugPatentWatch Database Preview

Clofarabine - Generic Drug Details

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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, Msn Labs Pvt Ltd, Mylan Labs Ltd, and Genzyme, and is included in six 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.

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

Pharmacology for clofarabine
Synonyms for clofarabine
(2R,3R,4S,5R)-5-(6-amino-2-chloro-9H-purin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol
(2R,3R,4S,5R)-5-(6-amino-2-chloro-9H-purin-9-yl)-4-fluoro-2-(hydroxymethyl)tetrahydrofuran-3-ol
(2R,3R,4S,5R)-5-(6-amino-2-chloro-purin-9-yl)-4-fluoro-2-(hydroxymethyl)tetrahydrofuran-3-ol
(2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol
(2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol, 2-chloro-2'-arabino-fluoro-2'-deoxyadenosine
123318-82-1
2-chloro-2'-arabino-fluoro-2'-deoxyadenosine
2-Chloro-9-(2-deoxy-2-fluoro-?-D-arabinofuranosyl)-9H-purin-6-amine
2-Chloro-9-(2-Deoxy-2-Fluoro-B -D-Arabinofuranosyl)-9h-Purin-6-Amine
2-Chloro-9-(2-deoxy-2-fluoro-b-D-arabinofuranosyl)-9H-purin-6-amine
2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-9H-purin-6-amine
2-chloro-9-(2-deoxy-2-fluoro-beta-d-arabinofuranosyl)-adenine
2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)adenine
2-chloro-9-(2'-deoxy-2'-fluoro-beta-D-arabinofuranosyl)adenine
2-Cl-2'-F-araA
318C821
3S211048
5-(6-amino-2-chloro-purin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol
762RDY0Y2H
9H-Purin-6-amine, 2-chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-
9H-Purine-6-amine,2-chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-
AB00430247_06
AB00430247-03
AB00430247-04
AC-274
AC1L3OC8
ACT05522
AK163076
AKOS005063562
AKOS015919355
AN-15999
API0002064
AS-12958
BC222364
BCP0726000280
BCP9000540
BIFK0045
Bio-0121
C-18934
C1-F-Ara-A
C10H11ClFN5O3
CAFdA
CAS-123318-82-1
CC-25917
CFB
CHEBI:681569
CHEMBL1750
Cl-F-Ara-A
Cl-F-araA
Clofarabin
clofarabina
Clofarabine (JAN/USAN/INN)
Clofarabine (USAN/INN)
Clofarabine [USAN:INN:BAN]
Clofarabine [USAN]
Clofarabine, >=98% (HPLC)
Clofarabine,Clolar, Evoltra
clofarabinum
Clofarex
Clolar
Clolar (TN)
Clolar, Evoltra, Clofarabine
CS-0373
D03546
D0R5RR
DB00631
DR001234
DSSTox_CID_26437
DSSTox_GSID_46437
DSSTox_RID_81613
DTXSID5046437
Evoltra
Evoltra (TN)
FT-0082882
FT-0601617
GTPL6802
HMS2090A07
HY-A0005
KB-49091
KS-00000650
LS-126466
MCULE-2276059681
MFCD00871077
MLS003915615
MolPort-005-941-711
NCGC00164553-01
NCGC00164553-02
NU004666
NU006255
PubChem19116
s1218
SAR-393590
SC-22779
SCHEMBL9040
SMR002530055
SR-01000930565
SR-01000930565-3
ST24046359
Tox21_112182
Tox21_112182_1
UNII-762RDY0Y2H
W-5182
WDDPHFBMKLOVOX-AYQXTPAHSA-N
Z1557400138
ZINC3798247
Tentative approvals for CLOFARABINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up20MG/20MLINJECTABLE;INJECTION

US Patents and Regulatory Information for clofarabine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208857-001 Nov 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Msn Labs Pvt Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 209775-001 Dec 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208860-001 Nov 6, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Expired US Patents for clofarabine

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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Non-Orange Book US Patents for 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 ➤ Sign Up
5,384,310 2'-fluoro-2-haloarabinoadinosines and their pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for clofarabine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/034 United Kingdom ➤ Sign Up 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
C0038 France ➤ Sign Up 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
C/GB06/040 United Kingdom ➤ Sign Up 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
C0029 France ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
Farmers Insurance
Julphar
Express Scripts
Federal Trade Commission
McKinsey
Boehringer Ingelheim
Argus Health

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.