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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 |
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 |
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 |
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
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
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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