TRIFERIC Drug Patent Profile

When do Triferic patents expire, and when can generic versions of Triferic launch?

Triferic is a drug marketed by Rockwell Medical Inc and is included in three NDAs. There are two patents protecting this drug.

This drug has thirteen patent family members in eleven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Triferic

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 8, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRIFERIC

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRIFERIC
What excipients (inactive ingredients) are in TRIFERIC?	TRIFERIC excipients list
DailyMed Link:	TRIFERIC at DailyMed

See drug prices for TRIFERIC

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TRIFERIC

NDA:

208551

Dosage:

FOR SOLUTION;INTRAVENOUS

NDA:

206317

Dosage:

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.

Recent Clinical Trials for TRIFERIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rockwell Medical Technologies, Inc.	Phase 4
Rockwell Medical Technologies, Inc.	Phase 3
Rockwell Medical Technologies, Inc.	Phase 2

See all TRIFERIC clinical trials

Pharmacology for TRIFERIC

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for TRIFERIC

TRIFERIC is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRIFERIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	FOR SOLUTION;INTRAVENOUS	208551-001	Apr 25, 2016		RX	Yes	Yes
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-002	Sep 4, 2015		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	FOR SOLUTION;INTRAVENOUS	208551-001	Apr 25, 2016		RX	Yes	Yes
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015		RX	Yes	Yes			Y

Expired US Patents for TRIFERIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015

International Patents for TRIFERIC

When does loss-of-exclusivity occur for TRIFERIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Canada

Croatia

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIFERIC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5617298
Slovenia	2016940
Slovenia	20151	Metode in farmacevtske zmesi za aplikacijo železa hemodializnim in peritonealno dializnim pacientom (METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS)
Denmark	0951470