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Last Updated: December 3, 2021

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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, Meitheal, MSN, Mylan Labs Ltd, Novast Labs, and Genzyme, and is included in eleven 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.

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
Medexus Pharma, Inc.Phase 2
Omar MianEarly Phase 1
TretheraPhase 1

See all clofarabine clinical trials

Generic filers with tentative approvals for CLOFARABINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free20MG/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
Gland Pharma Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 207831-001 Oct 31, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abon Pharms Llc CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 204029-001 May 9, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Msn CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 209775-001 Dec 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208860-001 Nov 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 208857-001 Nov 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 205375-001 Nov 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ⤷  Try it Free ⤷  Try it Free
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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