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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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021825

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NDA 021825 describes FERRIPROX, which is a drug marketed by Apopharma Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FERRIPROX profile page.

The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 021825
Tradename:FERRIPROX
Applicant:Apopharma Inc
Ingredient:deferiprone
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021825
Mechanism of ActionIron Chelating Activity
Suppliers and Packaging for NDA: 021825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FERRIPROX deferiprone TABLET;ORAL 021825 NDA ApoPharma USA, Inc. 52609-0006 52609-0006-1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52609-0006-1)
FERRIPROX deferiprone TABLET;ORAL 021825 NDA ApoPharma USA, Inc. 52609-0007 52609-0007-5 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52609-0007-5)
Paragraph IV (Patent) Challenges for 021825
Tradename Dosage Ingredient NDA Submissiondate
FERRIPROX TABLET;ORAL deferiprone 021825 2016-01-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 14, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC IRON OVERLOAD

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jul 25, 2019TE:RLD:Yes

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