Details for New Drug Application (NDA): 021825

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NDA 021825 describes FERRIPROX, which is a drug marketed by Chiesi and is included in three NDAs. It is available from one supplier. There are seven 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. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.

Summary for 021825

Tradename:	FERRIPROX
Applicant:	Chiesi
Ingredient:	deferiprone
Patents:	0

Pharmacology for NDA: 021825

Mechanism of Action	Iron 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	Chiesi USA, Inc.	10122-100	10122-100-10	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-10)
FERRIPROX	deferiprone	TABLET;ORAL	021825	NDA	Chiesi USA, Inc.	10122-103	10122-103-05	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-103-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Oct 14, 2011	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 30, 2024
Regulatory Exclusivity Use:	TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS
Regulatory Exclusivity Expiration:	Apr 30, 2028
Regulatory Exclusivity Use:	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS
Regulatory Exclusivity Expiration:	Apr 30, 2028
Regulatory Exclusivity Use:	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011

Expired US Patents for NDA 021825

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	⤷ Sign Up	⤷ Sign Up
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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