Details for New Drug Application (NDA): 208551

NDA 208551 describes TRIFERIC, which is a drug marketed by Rockwell Medical Inc and is included in three NDAs. There are two patents protecting this drug. Additional details are available on the TRIFERIC profile page.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.

Summary for 208551

Tradename:	TRIFERIC
Applicant:	Rockwell Medical Inc
Ingredient:	ferric pyrophosphate citrate
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208551

Dosage:

FOR SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	272MG IRON/PACKET
Approval Date:	Apr 25, 2016	TE:		RLD:	Yes
Patent:		Patent Expiration:	Apr 17, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Patent:		Patent Expiration:	Sep 8, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

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