TRIFERIC AVNU Drug Patent Profile

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When do Triferic Avnu patents expire, and what generic alternatives are available?

Triferic Avnu is a drug marketed by Rockwell Medical Inc and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in TRIFERIC AVNU 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.

DrugPatentWatch^® Generic Entry Outlook for Triferic Avnu

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 17, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TRIFERIC AVNU

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	11
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRIFERIC AVNU
What excipients (inactive ingredients) are in TRIFERIC AVNU?	TRIFERIC AVNU excipients list
DailyMed Link:	TRIFERIC AVNU at DailyMed

Drug patent expirations by year for TRIFERIC AVNU

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TRIFERIC AVNU

Generic Entry Date for TRIFERIC AVNU^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing NDA: 212860 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 AVNU

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 AVNU clinical trials

US Patents and Regulatory Information for TRIFERIC AVNU

TRIFERIC AVNU is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIFERIC AVNU 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 AVNU

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 THERAPY

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Glossary

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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 AVNU	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	212860-001	Mar 27, 2020		DISCN	Yes	No	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

International Patents for TRIFERIC AVNU

When does loss-of-exclusivity occur for TRIFERIC AVNU?

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: 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 AVNU around the world.

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Country	Patent Number	Title	Estimated Expiration
Spain	2383713		See Plans and Pricing
Denmark	2016940		See Plans and Pricing
Portugal	2016940		See Plans and Pricing
Poland	2016940		See Plans and Pricing
Japan	5489196		See Plans and Pricing
Austria	554754		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration