Clofarabine - Generic Drug Details

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, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, Novast Labs, and Genzyme, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for clofarabine

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	165
Patent Applications:	7,158
Drug Prices:	Drug price trends for clofarabine
What excipients (inactive ingredients) are in clofarabine?	clofarabine excipients list
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
GlycoMimetics Incorporated	Phase 1/Phase 2
John Horan, MD	Phase 1/Phase 2
Vastra Gotaland Region	Phase 3

See all clofarabine clinical trials

Generic filers with tentative approvals for CLOFARABINE

Applicant	Application No.	Strength	Dosage Form
		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

Anatomical Therapeutic Chemical (ATC) Classes for clofarabine

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CLOFARABINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLOLAR	Injection	clofarabine	1 mg/mL, 20 mL vial	021673	1	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
Mylan Labs Ltd	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	208860-001	Nov 6, 2017	AP	RX	No	No
Gland Pharma Ltd	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	207831-001	Oct 31, 2018	AP	RX	No	No
Accord Hlthcare	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	212034-001	Feb 22, 2019	AP	RX	No	No
Msn	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	209775-001	Dec 6, 2017	AP	RX	No	No
Dr Reddys	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	205375-001	Nov 6, 2017	AP	RX	No	No
Meitheal	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	213461-001	Oct 23, 2020	AP	RX	No	No
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	AP	RX	Yes	Yes

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
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004

EU/EMA Drug Approvals for clofarabine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ORPHELIA Pharma SAS	Ivozall	clofarabine	EMEA/H/C/005039 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.	Authorised	yes	no	no	2019-11-14
Genzyme Europe BV	Evoltra	clofarabine	EMEA/H/C/000613 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.,	Authorised	no	no	no	2006-05-29