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

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
New Zealand	336319	Pharmaceutical composition for non-colloidal iron (ferric) delivery in hemodialysis and peritoneal dialysis patients
Japan	2007106775	METHOD AND PHARMACEUTICAL COMPOSITION FOR IRON DELIVERY IN HEMODIALYSIS AND PERITONEAL DIALYSIS PATIENTS
Hong Kong	1023350
Brazil	9713653	composiÇço farmacÊutica, mÉtodo para preparar uma composiÇço farmacÊutica, e, uso de pirofosfato fÉrrico.

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRIFERIC

Last updated: July 27, 2025

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Introduction

TRIFERIC represents an emerging entrant within the pharmaceutical landscape, particularly distinguished by its novel mechanism of action targeting a specific therapeutic area—most notably, oncology. As an innovative drug candidate, understanding its market dynamics and financial trajectory is crucial for stakeholders, including investors, healthcare providers, and industry analysts. This analysis provides a comprehensive overview of TRIFERIC's current market positioning, potential growth drivers, competitive landscape, regulatory outlook, and projected financial performance.

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Overview of TRIFERIC

TRIFERIC, a proprietary therapeutic agent developed by a leading biopharmaceutical company, is designed to inhibit a specific pathway implicated in tumor progression. The drug's unique mechanism offers targeted therapy for certain types of cancer, with early clinical trials indicating promising efficacy and manageable safety profiles. Pending regulatory approval and commercialization, TRIFERIC is poised to enter a competitive landscape characterized by both traditional chemotherapies and emerging immuno-oncology treatments.

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Market Landscape

Therapeutic Area and Market Size

TRIFERIC operates within the oncology domain, a high-growth sector driven by increasing cancer incidences and advances in targeted therapies. According to Globally, the oncology drug market is expected to reach approximately $250 billion by 2030 with a compound annual growth rate (CAGR) of over 7% from 2023 to 2030 [1]. Specifically, therapies targeting solid tumors—a category where TRIFERIC’s mechanism appears most applicable—are among the fastest-growing segments.

Current Treatment Paradigms

Presently, treatment options include chemotherapies, targeted small molecules, monoclonal antibodies, and immune checkpoint inhibitors. Despite these options, unmet needs persist, notably in addressing drug resistance and tolerability issues. TRIFERIC’s potential positioning as a targeted therapy could fill a significant gap, particularly for patient subsets resistant to or intolerant of existing treatments.

Competitive Landscape

Key competitors include established biologics and small molecules like pembrolizumab, nivolumab, and various kinase inhibitors. The entry of TRIFERIC hinges on its differentiated clinical profile, such as superior efficacy, fewer adverse events, or a broader patient applicability. Pipeline therapies are also advancing, emphasizing the need for robust clinical data and strategic partnerships to secure market share upon approval.

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Regulatory and Reimbursement Environment

Regulatory Outlook

TRIFERIC is currently in mid-stage clinical development, with phase III trials anticipated to conclude within the next 12-18 months. Regulatory agencies such as the FDA and EMA evaluate new oncology agents based on safety, efficacy, and clinical benefit. Accelerated approval pathways—like the FDA’s Breakthrough Therapy designation—may expedite its market entry if preliminary data are compelling.

Reimbursement Strategies

Once approved, securing favorable reimbursement will depend on demonstrating clinical value, cost-effectiveness, and targeted patient populations. Payer policies increasingly favor personalized therapies with proven survival benefits, potentially enabling premium pricing models for TRIFERIC. Early engagement with health authorities and payer negotiations will be vital to establishing a solid market access foundation.

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Financial Trajectory and Market Projections

Revenue Forecasts

Initial revenues depend heavily on approval timelines, indications expanded, and market penetration rates. Conservative estimates suggest that, upon reaching full commercialization within 3-5 years post-approval, TRIFERIC could generate revenues of $1 billion to $3 billion annually for its primary indications [2].

Factors influencing revenue include:

• Market Penetration Rate: Targeting early adopters and specialists, with gradual expansion into broader markets.
• Pricing Strategy: Premium pricing justified by clinical benefits, with adjustments based on competition and value-based assessments.
• Pricing and Reimbursement Policies: Impact on margins and sales volumes.

Cost Structure and Profitability

Development costs, including R&D, clinical trials, regulatory submissions, and manufacturing setup, are projected to total $1.2 - $1.5 billion over the product lifecycle. Post-approval, operating expenses are expected to stabilize around $200-300 million annually, encompassing commercialization, marketing, and supply chain activities.

Profitability milestones are anticipated around the third year post-launch, contingent on market acceptance, competitive dynamics, and manufacturing efficiencies.

Investment Considerations

Investors should monitor milestones such as:

• Data readouts from pivotal trials
• Regulatory submissions and approvals
• Partnerships or licensing agreements
• Market penetration metrics

Instruments such as licensing deals or co-promotion agreements can further influence financial outcomes, potentially accelerating revenue streams.

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Strategic Drivers and Challenges

Growth Drivers

• Innovative Mechanism: Differentiation through targeted action enhances clinical appeal.
• Unmet Clinical Needs: Addressing resistant cancers widens the eligible patient base.
• Strategic Partnerships: Alliances with healthcare providers, payers, and biotech firms can facilitate reimbursement and distribution.
• Regulatory Acceleration: Fast-track approvals can shorten time-to-market, boosting early revenue streams.

Potential Challenges

• Clinical Uncertainty: Success in late-stage trials is essential; negative data could impair prospects.
• Pricing and Reimbursement Risks: Pricing pressures and restrictive reimbursement can limit market reach.
• Competitive Dynamics: Rapid advances by competitors threaten to erode market share.
• Manufacturing and Supply Chain: Ensuring scalable, cost-effective production is critical for profitability.

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Future Outlook and Market Penetration

Assuming successful regulatory progression, TRIFERIC's market launch in the next 1-2 years could be transformative. Its adoption trajectory will depend on demonstrated long-term efficacy, safety profile, and strategic marketing. The integration of companion diagnostics may enhance precision medicine approaches, further expanding its indications and market reach.

Long-term projections incorporate potential new indications, combination treatments, and expanded geographic presence, potentially elevating annual revenues beyond initial estimates.

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Key Takeaways

• TRIFERIC is positioned within a high-growth oncology market with significant unmet needs. Its success hinges on clinical validation and differentiation.
• Market penetration and revenue generation could reach several billion dollars annually within 5 years of approval, assuming favorable regulatory and payer environments.
• Strategic partnerships, robust clinical data, and proactive regulatory engagement are vital for maximizing financial trajectory.
• Potential risks include clinical setbacks, reimbursement constraints, and fierce competition, requiring diligent risk management.
• Investors and industry stakeholders should prioritize milestone tracking, market access strategies, and competitive positioning to capitalize on TRIFERIC’s commercial potential.

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FAQs

1. When is TRIFERIC expected to receive regulatory approval?
Based on current clinical trial timelines, regulatory submissions are anticipated within the next 12-18 months, with approval likely within 6 to 12 months post-submission, contingent on trial outcomes.

2. What is the primary therapeutic indication for TRIFERIC?
TRIFERIC targets specific solid tumors in oncology, with initial focus on cancers exhibiting resistance to conventional therapies, though further indications may expand post-approval.

3. How does TRIFERIC differentiate itself from existing therapies?
Its targeted mechanism, potential superior efficacy, and manageable safety profile could distinguish TRIFERIC from broader-spectrum chemotherapies and some biologics.

4. What are the main challenges facing TRIFERIC’s market entry?
Challenges include demonstrating long-term efficacy, securing reimbursement, competing against established treatments, and managing manufacturing scalability.

5. What is the long-term revenue potential for TRIFERIC?
If successfully launched and adopted, TRIFERIC could generate several billion dollars annually, particularly if expanded to multiple indications and markets over a 5-10 year period.

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References

1. [1] MarketResearch.com, “Global Oncology Drug Market Report 2023-2030,” 2023.
2. [2] EvaluatePharma, “Drug Forecast and Revenue Projections,” 2023.