Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Johnson and Johnson
McKesson
McKinsey
Baxter

Last Updated: January 31, 2023

Clofarabine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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
Drug Prices for clofarabine

See drug prices for clofarabine

Recent Clinical Trials for clofarabine

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

SponsorPhase
GlycoMimetics IncorporatedPhase 1/Phase 2
John Horan, MDPhase 1/Phase 2
Vastra Gotaland RegionPhase 3

See all clofarabine clinical trials

Generic filers with tentative approvals for CLOFARABINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing20MG/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
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland Pharma Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 207831-001 Oct 31, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 212034-001 Feb 22, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 209775-001 Dec 6, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 205375-001 Nov 6, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Meitheal CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 213461-001 Oct 23, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
Medtronic

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.