Details for New Drug Application (NDA): 021825

✉ Email this page to a colleague

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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	⤷ Subscribe	⤷ Subscribe
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.