You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

CLOFARABINE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Clofarabine patents expire, and what generic alternatives are available?

Clofarabine is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, and Novast Labs. and is included in eleven NDAs.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Clofarabine

A generic version of CLOFARABINE was approved as clofarabine by ABON PHARMS LLC on May 9th, 2017.

  Try a Trial

Summary for CLOFARABINE
Drug patent expirations by year 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
John Horan, MDPhase 1/Phase 2
GlycoMimetics IncorporatedPhase 1/Phase 2
Vastra Gotaland RegionPhase 3

See all CLOFARABINE clinical trials

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
Abon Pharms Llc CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 204029-001 May 9, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 210283-001 Dec 27, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 205375-001 Nov 6, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 213461-001 Oct 23, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 212034-001 Feb 22, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208857-001 Nov 6, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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
Sanofi B.V. 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

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.