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. 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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
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 Loss of Exclusivity (LOE) 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

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.

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	POWDER;INTRAVENOUS	208551-001	Apr 25, 2016		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-002	Sep 4, 2015		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	POWDER;INTRAVENOUS	208551-001	Apr 25, 2016		DISCN	Yes	No
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015		DISCN	Yes	No			Y
Rockwell Medical Inc	TRIFERIC AVNU	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	212860-001	Mar 27, 2020		DISCN	Yes	No				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
Canada	2550493	EMBALLAGE DU PYROPHOSPHATE FERRIQUE POUR DIALYSE (PACKAGING OF FERRIC PYROPHOSPHATE FOR DIALYSIS)
Slovenia	2016940
Cyprus	1113903
Canada	2276442	METHODE ET COMPOSITION PHARMACEUTIQUE POUR ADMINISTRER DU FER AUX PATIENTS SOUS HEMODIALYSE OU DIALYSE PERITONEALE (METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS)
Portugal	2016940

TRIFERIC Market Analysis and Financial Projection Experimental

Transforming Data into Market Domination: The Market Dynamics and Financial Trajectory of Triferic

Introduction

Triferic, a ferric pyrophosphate citrate (FPC) developed by Rockwell Medical, is a groundbreaking treatment for iron deficiency and anemia management, particularly in patients undergoing hemodialysis. This article delves into the market dynamics and financial trajectory of Triferic, highlighting its growth, challenges, and future prospects.

Market Context: Intravenous Iron Drugs

The intravenous iron drugs market is experiencing significant growth, driven by the increasing prevalence of chronic kidney disease (CKD), inflammatory bowel disease (IBD), and cancer, which often lead to iron deficiency anemia (IDA)[4].

• Global Market Size: The intravenous iron drugs market was valued at USD 2.6 billion in 2021 and is projected to grow at a CAGR of 8.5% from 2022 to 2032, reaching a valuation of around USD 6.3 billion by 2032[4].
• Regional Growth: The Asia Pacific and European markets are expected to see substantial growth due to improving healthcare infrastructure and the increasing incidence of malignancies[4].

Rockwell Medical's Financial Performance

Rockwell Medical, the company behind Triferic, has shown notable financial improvements in recent years.

First Quarter 2022 Financials

• Revenue Growth: Net sales for the first quarter of 2022 were $16.1 million, a 4.2% increase year-over-year, primarily driven by increased sales of dialysis concentrates[1].
• Supply Agreement: The company renegotiated its supply contract with DaVita, which included price increases and the pass-through of certain costs, expected to improve margins for the remainder of 2022[1].
• Net Loss: Despite revenue growth, Rockwell Medical reported a net loss of $7.2 million for the first quarter of 2022, though this was an improvement from the $7.8 million net loss in the same period of 2021[1].

Third Quarter 2024 Financials

• Significant Revenue Increase: Net product sales for the third quarter of 2024 surged to $28.3 million, a 31% year-over-year increase. This included a special large order of premium-priced products from their largest customer[3].
• Gross Profit and Margin: Gross profit grew 183% to $6.2 million, with a gross margin expansion to 22% from 9% in the same period of 2023[3].
• Cash Flow and Net Income: The company generated $4.3 million in cash flow from operations and achieved a net income of $1.7 million, marking a significant turnaround from the net loss of $1.9 million in Q3 2023[3].

Strategic Developments and Partnerships

Rockwell Medical has been actively engaging in strategic developments to strengthen its market position.

Supply Agreement with DaVita

• The amended and expanded supply agreement with DaVita included a $7.5 million investment in Rockwell's convertible preferred stock, with the potential for an additional $7.5 million investment subject to certain conditions. This agreement has significantly bolstered Rockwell's financial position[1].

Distribution Agreement with Nipro Medical

• Rockwell Medical signed a new distribution agreement with Nipro Medical, valued at a minimum of $5.0 million for the first year. This agreement is part of the company's strategy to expand its presence in global markets[3].

Clinical Trials and Regulatory Updates

Triferic has been undergoing various clinical trials to establish its efficacy and safety.

Phase 3 Trials

• Rockwell Medical completed patient enrollment ahead of schedule in the pivotal Phase 3 trial of Triferic in China. This trial is crucial for expanding the drug's approval and market reach[1].
• Efficacy and Safety: Phase 3 trials have shown positive results, with Triferic demonstrating efficacy and safety comparable to or better than placebo in several studies[2].

Market Challenges and Future Prospects

Despite the positive financial and clinical developments, Rockwell Medical faces several challenges.

Customer Volume Reduction

• The company's largest customer has indicated an expected volume reduction in 2025, which could decrease sales by $31-38 million. This poses a significant challenge for maintaining the current growth trajectory[3].

Market Competition

• The intravenous iron drugs market is competitive, with key players such as AMAG Pharmaceuticals, AbbVie Inc., Daiichi Sankyo Company Ltd., Sanofi, and Vifor Pharma Management Ltd. Rockwell Medical must continue to innovate and expand its product portfolio to remain competitive[4].

Strategic Pivot and Expansion Plans

To address these challenges, Rockwell Medical is focusing on operational efficiency, premium pricing, and market expansion.

Operational Efficiency

• The company has been working on improving its operational efficiency, which has contributed to the significant increase in gross margin and profitability[3].

Premium Pricing

• The special large order of premium-priced products from their main customer demonstrates Rockwell's pricing power, though sustainability remains a concern given the customer's planned volume reduction[3].

Global Market Expansion

• Rockwell Medical is expanding its hemodialysis product portfolio and introducing new products to the market. The distribution agreement with Nipro Medical is a key step in this strategy, aiming to diversify revenue streams and mitigate the impact of volume reductions from major customers[3].

Key Takeaways

• Revenue Growth: Rockwell Medical has seen significant revenue growth, driven by increased sales of Triferic and other dialysis concentrates.
• Financial Turnaround: The company has achieved profitability on a cash flow and adjusted EBITDA basis, marking a substantial turnaround.
• Strategic Partnerships: Agreements with DaVita and Nipro Medical have strengthened Rockwell's financial and market position.
• Clinical Success: Triferic has shown positive results in clinical trials, enhancing its market potential.
• Challenges Ahead: The company faces challenges such as customer volume reductions and market competition, requiring continued innovation and strategic execution.

FAQs

What is Triferic, and how does it work?

Triferic, or ferric pyrophosphate citrate (FPC), is a drug developed by Rockwell Medical to treat iron deficiency and anemia in patients undergoing hemodialysis. It works by delivering iron directly to the bloodstream during dialysis, helping to maintain healthy iron levels.

What are the key financial highlights for Rockwell Medical in Q3 2024?

In Q3 2024, Rockwell Medical reported net product sales of $28.3 million, a 31% year-over-year increase, with a gross profit of $6.2 million and a gross margin of 22%. The company also generated $4.3 million in cash flow from operations and achieved a net income of $1.7 million[3].

What are the challenges facing Rockwell Medical in the near future?

One of the significant challenges is the expected volume reduction by their largest customer in 2025, which could decrease sales by $31-38 million. Additionally, the company faces competition in the intravenous iron drugs market and must continue to innovate and expand its product portfolio[3].

How is Rockwell Medical expanding its market presence?

Rockwell Medical is expanding its market presence through strategic partnerships, such as the distribution agreement with Nipro Medical, and by introducing new products to the market. These efforts aim to diversify revenue streams and mitigate the impact of volume reductions from major customers[3].

What is the projected growth of the intravenous iron drugs market?

The intravenous iron drugs market is projected to grow at a CAGR of 8.5% from 2022 to 2032, reaching a valuation of around USD 6.3 billion by 2032. The market is driven by the increasing prevalence of chronic kidney disease, inflammatory bowel disease, and cancer[4].

What are the key regions driving the growth of the intravenous iron drugs market?

The key regions driving the growth include the Asia Pacific, Europe, and the United States. The Asia Pacific market is expected to grow at a CAGR of 8.6%, while the U.S. market is projected to expand at a CAGR of 9.3% from 2022 to 2032[4].

Sources

1. Rockwell Medical Provides First Quarter 2022 Financial and Operational Update. Rockwell Medical, Inc. https://ir.rockwellmed.com/press-releases/news-details/2022/Rockwell-Medical-Provides-First-Quarter-2022-Financial-and-Operational-Update/default.aspx
2. Ferric Pyrophosphate Citrate - Drug Targets, Indications, Patents. Synapse. https://synapse.patsnap.com/drug/3379bcebbbfb4d6bb9e6bc30ed4d4277
3. Rockwell Medical Reports Third Quarter 2024 Earnings, Generates Profitability on a Cash Flow and Adjusted EBITDA Basis for the Second Consecutive Quarter. Stock Titan. https://www.stocktitan.net/news/RMTI/rockwell-medical-reports-third-quarter-2024-earnings-generates-tg5cviziwiub.html
4. Intravenous Iron Drugs Market Share, Growth & Outlook – 2032. Future Market Insights. https://www.futuremarketinsights.com/reports/intravenous-iron-drugs-market