BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Harvard Business School
Farmers Insurance
Accenture
QuintilesIMS
Healthtrust
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204029

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NDA 204029 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Amneal Pharms Co, Dr Reddys Labs Ltd, and Mylan Labs Ltd, and is included in four NDAs. It is available from four suppliers. Additional details are available on the CLOFARABINE profile page.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 204029
Tradename:CLOFARABINE
Applicant:Abon Pharms Llc
Ingredient:clofarabine
Patents:0
Pharmacology for NDA: 204029
Suppliers and Packaging for NDA: 204029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine INJECTABLE;IV (INFUSION) 204029 ANDA Fresenius-Kabi 63323-572 63323-572-70 1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) > 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength20MG/20ML (1MG/ML)
Approval Date:May 9, 2017TE:APRLD:No
Regulatory Exclusivity Expiration:Nov 5, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Dow
Novartis
UBS
Medtronic
McKesson
Argus Health
Baxter

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