Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 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.

Drug Prices for CLOFARABINE

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Recent Clinical Trials for CLOFARABINE

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SponsorPhase
Milton S. Hershey Medical CenterPhase 2
Mesoblast, Inc.Phase 2
ShirePhase 2/Phase 3

See all CLOFARABINE clinical trials

Recent Litigation for CLOFARABINE

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District Court Litigation
Case NameDate
GENZYME CORPORATION v. HERITAGE PHARMA LABS, INC.2014-09-24
SOUTHERN RESEARCH INSTITUTE v. ABON PHARMACEUTICALS LLC2012-07-27

See all CLOFARABINE litigation

Generic filers with tentative approvals for CLOFARABINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MG/20MLINJECTABLE;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
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 212034-001 Feb 22, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 210283-001 Dec 27, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208857-001 Nov 6, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 207831-001 Oct 31, 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

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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