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Last Updated: November 22, 2024

CLOFARABINE - Generic Drug Details


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What are the generic 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, 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

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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

Generic filers with tentative approvals for CLOFARABINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up20MG/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
Novast Labs CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 210270-001 Sep 14, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 205375-001 Nov 6, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 209775-001 Dec 6, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 207831-001 Oct 31, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ⤷  Sign Up ⤷  Sign Up
>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
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

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