Details for New Drug Application (NDA): 208030

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NDA 208030 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 208030

Tradename:	FERRIPROX
Applicant:	Chiesi
Ingredient:	deferiprone
Patents:	1

Pharmacology for NDA: 208030

Mechanism of Action	Iron Chelating Activity

Suppliers and Packaging for NDA: 208030

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FERRIPROX	deferiprone	SOLUTION;ORAL	208030	NDA	Chiesi USA, Inc.	10122-101	10122-101-50	500 mL in 1 BOTTLE, PLASTIC (10122-101-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Sep 9, 2015	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 3 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 208030

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015	⤷ Sign Up	⤷ Sign Up
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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