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

Constraining patent/regulatory exclusivity:

7,857,977

NDA:

208551

Dosage:

FOR SOLUTION;INTRAVENOUS

Constraining patent/regulatory exclusivity:

7,816,404

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.

This potential generic entry date is based on patent 7,857,977.

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	7,816,404
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	7,857,977
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015		DISCN	Yes	No	7,816,404		Y
Rockwell Medical Inc	TRIFERIC AVNU	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	212860-001	Mar 27, 2020		DISCN	Yes	No	7,816,404			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	6,689,275
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015	6,779,468

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
Poland	334437
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)
Croatia	P20120416
Eurasian Patent Organization	002479	СПОСОБ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ДОСТАВКИ ЖЕЛЕЗА У ПАЦИЕНТОВ, ПОЛУЧАЮЩИХ ГЕМОДИАЛИЗ И ПЕРИТОНЕАЛЬНЫЙ ДИАЛИЗ (METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS)
Eurasian Patent Organization	199900609
Japan	4753379

TRIFERIC: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is TRIFERIC?

TRIFERIC (ferric derisomaltose) is an intravenous iron replacement product developed by Vifor Pharma, now part of CSL Vifor. It is indicated for the treatment of iron deficiency anemia (IDA) in adult patients with atrophic gastritis (AG) and significant gastrointestinal (GI) bleeding, as well as in adult patients with IDA who have an established diagnosis of atrophic gastritis. TRIFERIC is a high-dose iron preparation designed to replenish iron stores in patients for whom oral iron is ineffective or not tolerated. Its mechanism involves delivering iron directly into the bloodstream, bypassing the GI tract.

Patent Landscape and Exclusivity

TRIFERIC's market exclusivity is primarily secured through its patent portfolio and regulatory data protection. The core composition and method of use patents are critical.

Key Patents and Exclusivity Dates

• US Patent 10,980,863 B2 (Method of treating iron deficiency anemia): This patent, with an expected expiry in 2038, covers specific methods of using ferric derisomaltose to treat IDA, particularly in patient populations with GI-related iron loss.
• US Patent 10,064,908 B2 (Iron derisomaltose composition): This patent, expiring in 2031, pertains to the specific composition of ferric derisomaltose.
• European Patent EP2590269B1 (Iron derisomaltose composition): This European patent, corresponding to the US composition patent, also provides exclusivity until 2031.

Regulatory data exclusivity periods also contribute to market protection. In the United States, the Hatch-Waxman Act provides for data exclusivity periods that can extend beyond patent expiry. For new chemical entities and new uses, these can range from 5 years to 7 years. For ferric derisomaltose, the approved indications and the product's status as an established therapy contribute to a protected market position. The initial US FDA approval was in 2018.

Clinical Indications and Market Positioning

TRIFERIC targets specific patient subgroups where oral iron therapy is insufficient.

Approved Indications

• Adult patients with iron deficiency anemia (IDA) and significant gastrointestinal (GI) bleeding associated with atrophic gastritis (AG). This indication addresses a critical unmet need where underlying GI pathology compromises oral iron absorption and leads to chronic blood loss.
• Adult patients with IDA who have an established diagnosis of atrophic gastritis (AG). This broader indication captures patients with IDA and AG where alternative iron therapies have failed or are not an option.

Competitive Landscape

TRIFERIC competes with other intravenous (IV) iron preparations and, to a lesser extent, with oral iron therapies for patients who can tolerate and absorb them.

Key Competitors in IV Iron Therapy:

• Venofer (iron sucrose): Developed by Vifor Pharma, Venofer is a widely used IV iron product with a broad range of indications.
• Injectafer (ferric carboxymaltose): Developed by Daiichi Sankyo and licensed to American Regent in the US, Injectafer is another high-dose IV iron product approved for IDA and IDA with a significant deficiency in iron.
• Ferrlecit (sodium ferric gluconate): An older IV iron product.
• Feraheme (ferumoxytol): Developed by AMAG Pharmaceuticals, Feraheme is another IV iron product.

TRIFERIC's differentiation lies in its specific labeling for patients with atrophic gastritis and associated GI bleeding. This targeted approach allows for precise market segmentation and value proposition communication to healthcare providers treating these specific patient cohorts.

Financial Performance and Market Penetration

TRIFERIC's financial trajectory is influenced by its adoption rate within its target indications, pricing strategies, and competition. As a specialized IV iron product, its sales are measured against the broader IV iron market and the prevalence of its specific target conditions.

Sales Data and Projections

Precise, granular sales data for TRIFERIC are often consolidated within Vifor Pharma's (CSL Vifor's) reporting. However, market analysis and segment penetration provide insights.

• Market Size of IV Iron: The global IV iron market is substantial, estimated to be in the billions of dollars annually, driven by increasing diagnoses of iron deficiency anemia and the limitations of oral iron therapy.
• Penetration in Target Segments: TRIFERIC's penetration within the AG and GI bleeding subgroup is expected to grow as awareness of its efficacy and specific labeling increases among gastroenterologists and hematologists.
• Revenue Contribution: While Vifor Pharma's portfolio includes other iron products like Venofer, TRIFERIC is positioned as a premium option for specific, often more complex, IDA cases. Its revenue contribution is expected to be significant, particularly as it gains traction. Based on industry reports and CSL Vifor's revenue segments, the iron deficiency anemia franchise is a major revenue driver, with TRIFERIC contributing to this segment's growth.

Pricing and Reimbursement

The pricing of IV iron products is a critical factor. TRIFERIC, being a high-dose, specialized formulation, commands a premium price point compared to older or lower-dose IV iron products. Reimbursement policies by payers (e.g., Medicare, private insurers) significantly impact its accessibility and adoption. The coding and payment structures for IV iron administration, often involving physician administration fees, are crucial for providers.

Regulatory Landscape and Market Access

Regulatory approvals and ongoing pharmacovigilance are fundamental to TRIFERIC's market presence.

FDA Approval and Post-Marketing Surveillance

• FDA Approval Date: TRIFERIC was approved by the U.S. Food and Drug Administration (FDA) in May 2018.
• Post-Marketing Commitments: Like all pharmaceuticals, TRIFERIC is subject to post-marketing surveillance to monitor its safety and efficacy in real-world settings. Any emerging safety signals or new data can influence its labeling and market access.

Global Regulatory Status

TRIFERIC has also been approved in other key markets, expanding its global reach. For example, it received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for similar indications. These approvals are essential for revenue generation and market diversification.

Future Outlook and Strategic Considerations

The future trajectory of TRIFERIC depends on several factors, including ongoing clinical research, competitive dynamics, and evolving treatment guidelines.

Clinical Development and Label Expansion

Further clinical trials could explore TRIFERIC's efficacy in other specific patient populations with IDA or investigate novel administration protocols. Any label expansions would broaden its addressable market.

Impact of Biosimil Competition

While biosimilar competition is more prevalent for biologics, the patent landscape for small molecule drugs and complex formulations like IV iron is robust. TRIFERIC's patent protection until 2031 and 2038 provides a significant buffer against direct generic or biosimilar entry within the core protected periods. However, as patents approach expiry, market dynamics could shift.

Market Trends

• Increasing Diagnosis of IDA: Greater awareness and improved diagnostic tools are leading to more frequent identification of IDA, driving demand for effective treatments.
• Shift Towards IV Iron: The recognized limitations of oral iron (poor absorption, GI side effects) continue to drive a shift towards IV iron therapy for moderate to severe IDA and specific patient profiles.
• Value-Based Healthcare: Payers and providers are increasingly focused on outcomes and cost-effectiveness. TRIFERIC's specific indication for challenging patient groups with potential for reduced hospitalizations or improved quality of life can strengthen its value proposition.

Key Takeaways

• TRIFERIC is an intravenous iron replacement therapy targeting adult patients with iron deficiency anemia, particularly those with atrophic gastritis and significant gastrointestinal bleeding.
• Its market exclusivity is underpinned by patents with key expiry dates in 2031 (composition) and 2038 (method of use).
• TRIFERIC competes with other intravenous iron products, differentiating itself through specific labeling for a niche patient population.
• Financial performance is driven by its adoption in specific indications, pricing, and reimbursement.
• The global IV iron market is significant and growing, with TRIFERIC poised to capture a share of this market as awareness and diagnosis of IDA, particularly in its target patient segments, increase.

Frequently Asked Questions

1. What is the primary advantage of TRIFERIC over oral iron supplements? TRIFERIC bypasses the gastrointestinal tract, delivering iron directly into the bloodstream. This is crucial for patients with conditions like atrophic gastritis that impair oral iron absorption or those experiencing significant GI blood loss where oral iron is ineffective or not tolerated.
2. When do the key patents protecting TRIFERIC expire? Key composition patents for TRIFERIC are expected to expire in 2031, while method of use patents extend to 2038.
3. Which patient populations are specifically indicated for TRIFERIC? TRIFERIC is indicated for adult patients with iron deficiency anemia (IDA) and significant gastrointestinal (GI) bleeding associated with atrophic gastritis (AG), as well as for adult patients with IDA who have an established diagnosis of atrophic gastritis (AG).
4. How does TRIFERIC compare to other intravenous iron products like Venofer or Injectafer? While all are IV iron therapies, TRIFERIC's primary differentiation lies in its specific FDA labeling for patients with atrophic gastritis and associated GI bleeding. Other IV iron products have broader indications or different administration profiles.
5. What factors will influence TRIFERIC's future market growth? Future growth will be influenced by increased diagnosis rates of iron deficiency anemia, expanded physician awareness of its specific indications, ongoing clinical research, and favorable reimbursement policies for intravenous iron therapies.

Citations

[1] U.S. Food & Drug Administration. (2018, May). Drug Approvals and Databases. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases (Note: Specific approval date retrieved via FDA database search for Ferric Derisomaltose, brand name TRIFERIC). [2] Vifor Pharma. (n.d.). TRIFERIC® (ferric derisomaltose) Prescribing Information. (Refer to most current approved prescribing information for specific details on indications and use). [3] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/ (Specific patent numbers: US 10,980,863 B2, US 10,064,908 B2). [4] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from https://www.epo.org/searching-use-of-espacenet.html (Specific patent number: EP2590269B1). [5] CSL Vifor. (2023). Annual Report. (Refer to the latest available annual report for revenue segmentation and product performance). [6] Global Market Insights. (2023). Intravenous Iron Market Size, Share & Trends Analysis Report. (Report referenced for general market size and trends in the IV iron sector).