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Last Updated: December 5, 2020

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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 patent protection?

Clofarabine is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys Labs Ltd, Gland Pharma Ltd, Hospira Inc, MSN, Mylan Labs Ltd, Novast Labs, 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:	84
Clinical Trials:	157
Patent Applications:	1,138
Drug Prices:	Drug price trends 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
Baxalta US Inc.	Phase 2/Phase 3

See all clofarabine clinical trials

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

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
Dr Reddys Labs Ltd	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	205375-001	Nov 6, 2017	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Amneal	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	208857-001	Nov 6, 2017	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
Accord Hlthcare	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	212034-001	Feb 22, 2019	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
>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 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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