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Last Updated: May 19, 2022

TRIFERIC Drug Patent Profile


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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

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Summary for TRIFERIC
Drug patent expirations by year for TRIFERIC
Drug Prices for TRIFERIC

See drug prices for TRIFERIC

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TRIFERIC
Generic Entry Dates for TRIFERIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SOLUTION;INTRAVENOUS
Generic Entry Dates for TRIFERIC*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
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

US Patents and Regulatory Information for TRIFERIC

TRIFERIC is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIFERIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

Packaging of ferric pyrophosphate for dialysis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

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

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

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

Patent: 4754
Estimated Expiration: See Plans and Pricing

Canada

Patent: 50493
Estimated Expiration: See Plans and Pricing

Patent: 38081
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120416
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13903
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 16940
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 16940
Estimated Expiration: See Plans and Pricing

Japan

Patent: 89196
Estimated Expiration: See Plans and Pricing

Patent: 09108027
Estimated Expiration: See Plans and Pricing

Poland

Patent: 16940
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 16940
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 16940
Estimated Expiration: See Plans and Pricing

Spain

Patent: 83713
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Slovenia 2016940 See Plans and Pricing
Slovenia 20151 Metode in farmacevtske zmesi za aplikacijo ┼żeleza hemodializnim in peritonealno dializnim pacientom (METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS) See Plans and Pricing
Denmark 0951470 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Mallinckrodt
Colorcon
McKesson
Merck

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.