Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Medtronic
Harvard Business School
Express Scripts
Johnson and Johnson

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Drug Master Files for: ICOSAPENT ETHYL

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ICOSAPENT ETHYL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
22077 I II 10/9/2008 CHEMPORT INC EICOSAPENTAENOIC ACID, 90% ETHYL ESTER
23911 A II 7/7/2010 PRONOVA BIOPHARMA NORGE AS EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)
26271 A II 8/1/2012 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD ETHYL ICOSAPENTATE
26892 A II 2/26/2013 KD PHARMA BEXBACH GMBH EICOSAPENTAENOIC ACID ETHYL ESTER
27182 A II 5/23/2013 FINORGA SAS ICOSAPENT ETHYL
27998 A II 2/10/2014 AK AND MN BIOFARM CO LTD AK & MN BIOFARM ICOSAPENTATE
>DMF No. >Status >Type >Submission Date >Holder >Subject

Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Moodys
Dow
McKesson
Colorcon

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