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Last Updated: December 15, 2019

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Clofarabine - Generic Drug Details

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What are the generic drug sources for clofarabine and what is the scope of freedom to operate?

Clofarabine is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Accord Hlthcare, Amneal Pharms Co, Dr Reddys Labs Ltd, Gland Pharma Ltd, Hospira Inc, Ingenus Pharms Llc, Msn Labs Pvt Ltd, Mylan Labs Ltd, and Genzyme, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for clofarabine

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	11
Suppliers / Packagers:	10
Bulk Api Vendors:	82
Clinical Trials:	155
Patent Applications:	6,938
Drug Prices:	Drug price trends for clofarabine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clofarabine
DailyMed Link:	clofarabine at DailyMed

See drug prices for clofarabine

Recent Clinical Trials for clofarabine

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 2
Mesoblast, Inc.	Phase 2
Bristol-Myers Squibb	Phase 2/Phase 3

See all clofarabine clinical trials

Recent Litigation for clofarabine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
GENZYME CORPORATION v. HERITAGE PHARMA LABS, INC.	2014-09-24
SOUTHERN RESEARCH INSTITUTE v. ABON PHARMACEUTICALS LLC	2012-07-27

See all clofarabine litigation

Generic filers with tentative approvals for CLOFARABINE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	20MG/20ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for clofarabine

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

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-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
AKOS005063562
AKOS015919355
AN-15999
API0002064
AS-12958
BC222364
BCP0726000280
BCP23422
BCP9000540
BIFK0045
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:BAN]
Clofarabine [USAN]
Clofarabine, >=98% (HPLC)
Clofarabine,Clolar, Evoltra
clofarabinum
Clofarex
Clolar
Clolar (TN)
CS-0373
D03546
DB00631
DSSTox_CID_26437
DSSTox_GSID_46437
DSSTox_RID_81613
DTXSID5046437
Evoltra
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
PubChem19116
s1218
SAR-393590
SB17339
SC-22779
SCHEMBL9040
SMR002530055
SR-01000930565
SR-01000930565-3
ST24046359
SW218080-2
Tox21_112182
Tox21_112182_1
UNII-762RDY0Y2H
W-5182
WDDPHFBMKLOVOX-AYQXTPAHSA-N
Z1557400138
ZINC3798247

Paragraph IV (Patent) Challenges for CLOFARABINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CLOLAR	SOLUTION;INTRAVENOUS	clofarabine	021673	2012-02-23

US Patents and Regulatory Information for clofarabine

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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
Msn Labs Pvt Ltd	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	209775-001	Dec 6, 2017	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Abon Pharms Llc	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029-001	May 9, 2017	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	AP	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Ingenus Pharms Llc	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	210270-001	Sep 14, 2018	AP	RX	No	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

Expired US Patents for clofarabine

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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

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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 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.

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