Details for New Drug Application (NDA): 212269

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NDA 212269 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 212269

Tradename:	FERRIPROX
Applicant:	Chiesi
Ingredient:	deferiprone
Patents:	6

Pharmacology for NDA: 212269

Mechanism of Action	Iron Chelating Activity

Suppliers and Packaging for NDA: 212269

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FERRIPROX	deferiprone	TABLET;ORAL	212269	NDA	Chiesi USA, Inc.	10122-104	10122-104-01	50 TABLET in 1 BLISTER PACK (10122-104-01)
FERRIPROX	deferiprone	TABLET;ORAL	212269	NDA	Chiesi USA, Inc.	10122-104	10122-104-05	50 TABLET in 1 BOTTLE, PLASTIC (10122-104-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	May 19, 2020	TE:		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 212269

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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