TRIFERIC AVNU Drug Patent Profile

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

Summary for TRIFERIC AVNU

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	11
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

See drug prices for TRIFERIC AVNU

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

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.

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

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				Y

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

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 AVNU around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2016940
Cyprus	1113903
Portugal	2016940

TRIFERIC AVNU Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triferic AVNU

Introduction to Triferic AVNU

Triferic AVNU, developed by Rockwell Medical Inc., is an intravenous (IV) formulation of ferric pyrophosphate citrate, designed to replace iron and maintain hemoglobin levels in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). It is the only FDA-approved therapy, along with Triferic Dialysate, for this specific indication in the U.S.[1].

Regulatory Approval and Availability

Triferic AVNU received FDA approval in March 2020, marking a significant milestone for Rockwell Medical. The drug is now available in the United States, offering healthcare providers an additional option for managing anemia in patients undergoing hemodialysis[1].

Mechanism of Action

Triferic AVNU delivers approximately 5-7 mg of iron with every hemodialysis treatment, which is immediately and completely donated to transferrin, the body's iron carrier. This mechanism ensures that iron is transported to the bone marrow to be incorporated into hemoglobin without increasing iron stores, as measured by ferritin levels[1].

Market Need and Impact

Triferic AVNU addresses a critical medical need by providing a physiologic iron maintenance therapy for patients with functional iron deficiency, a common condition in those with end-stage kidney disease. This therapy helps maintain hemoglobin levels without the risks associated with increased iron stores, making it a valuable treatment option for this patient population[1].

Commercialization and Sales

Despite its clinical benefits, the commercialization of Triferic AVNU has faced several challenges. Rockwell Medical initially invested heavily in the commercialization of Triferic and Triferic AVNU but later decided to cease spending on these products due to minimal economic returns. The company has since pivoted back to its core business, focusing on dialysis concentrates and other more profitable ventures[3].

Financial Performance

The financial performance of Rockwell Medical, particularly in relation to Triferic AVNU, has been mixed. In the first quarter of 2022, Rockwell Medical reported net sales of $16.1 million, a 4.2% increase year-over-year, primarily driven by sales of dialysis concentrates rather than Triferic AVNU. However, the company incurred a gross loss of $0.8 million due to inflationary pressures and supply chain issues affecting their concentrates business[2][4].

International Partnerships

While Rockwell Medical has suspended commercialization efforts for Triferic AVNU in the U.S., the company allows international partners to continue marketing the product. For instance, Triferic AVNU received approval from Health Canada, although this approval was later listed as "Cancelled Pre Approval" due to the termination of the distribution agreement in Canada[3].

Challenges and Risks

The commercial success of Triferic AVNU has been hindered by several factors, including:

• Thin Margins and Competition: Rockwell Medical faces significant competition in the dialysis market, and the margins for their products, including Triferic AVNU, are thin[3].
• Supply Chain Issues: Inflationary pressures and national supply chain issues have impacted the company's ability to maintain profitable margins[2][4].
• Regulatory Hurdles: The cancellation of the market authorization for Triferic AVNU in Canada highlights the regulatory challenges the product faces internationally[3].

Future Outlook

Rockwell Medical's decision to discontinue significant commercialization efforts for Triferic AVNU in the U.S. marks a shift towards more financially sustainable business strategies. The company is focusing on its core dialysis concentrates business and exploring other therapeutic areas with better economic prospects.

Key Takeaways

• Regulatory Approval: Triferic AVNU is FDA-approved for replacing iron and maintaining hemoglobin in patients with HDD-CKD.
• Commercial Challenges: Despite its clinical benefits, the product has faced significant commercialization challenges.
• Financial Performance: The financial impact of Triferic AVNU has been minimal compared to other business segments of Rockwell Medical.
• International Efforts: International partnerships continue, although with limited capital and operational resource expenditure from Rockwell Medical.
• Future Focus: Rockwell Medical is pivoting towards more profitable business segments, including dialysis concentrates.

FAQs

Q1: What is Triferic AVNU used for? Triferic AVNU is used to replace iron and maintain hemoglobin levels in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD)[1].

Q2: When was Triferic AVNU approved by the FDA? Triferic AVNU was approved by the FDA in March 2020[1].

Q3: Why did Rockwell Medical cease commercialization efforts for Triferic AVNU in the U.S.? Rockwell Medical ceased commercialization efforts due to minimal economic returns and significant financial strain from the project[3].

Q4: What are the unique benefits of Triferic AVNU? Triferic AVNU delivers iron immediately and completely to transferrin, ensuring it is incorporated into hemoglobin without increasing iron stores[1].

Q5: How has the international market responded to Triferic AVNU? The international market response has been mixed, with approval in Canada but subsequent cancellation of market authorization due to distribution agreement issues[3].

Sources

1. Rockwell Medical Announces U.S. Availability of Triferic® AVNU - Biospace
2. Rockwell Medical Provides First Quarter 2022 Financial and Operational Update - PR Newswire
3. Rockwell Medical: New Course Amid Market Challenges - Seeking Alpha
4. Rockwell Medical Provides First Quarter 2022 Financial and Operational Update - Rockwell Medical IR
5. 2023.05 RMTI Investor Presentation - FINAL - Rockwell Medical Investor Presentation