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Last Updated: December 5, 2020

DrugPatentWatch Database Preview

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.

Drug Prices for clofarabine

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Recent Clinical Trials for clofarabine

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

SponsorPhase
Milton S. Hershey Medical CenterPhase 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 Trial20MG/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 NDA Submissiondate
CLOLAR SOLUTION;INTRAVENOUS clofarabine 021673 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
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

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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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
Medtronic

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