VELPHORO Drug Patent Profile

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

Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and thirty-five patent family members in thirty-six countries.

The generic ingredient in VELPHORO is ferric oxyhydroxide. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Velphoro

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 23, 2030. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VELPHORO

International Patents:	135
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for VELPHORO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELPHORO
What excipients (inactive ingredients) are in VELPHORO?	VELPHORO excipients list
DailyMed Link:	VELPHORO at DailyMed

See drug prices for VELPHORO

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

Constraining patent/regulatory exclusivity:

9,561,251*PED

NDA:

205109

Dosage:

TABLET, CHEWABLE;ORAL

^*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 VELPHORO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 4
Vifor Fresenius Medical Care Renal Pharma	Phase 2
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2

See all VELPHORO clinical trials

Pharmacology for VELPHORO

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for VELPHORO

VELPHORO is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,561,251.

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
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	9,561,251*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,682,376*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,925,896*PED				Y

Expired US Patents for VELPHORO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013	6,174,442

International Patents for VELPHORO

When does loss-of-exclusivity occur for VELPHORO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 VELPHORO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2014062120	PHARMACEUTICAL COMPOSITIONS
Mexico	378141	COMPOSICIÓN FARMACÉUTICA, QUE COMPRENDE PARTÍCULAS DE AGLUTINANTE DE FOSFATO. (PHARMACEUTICAL COMPOSITION, COMPRISING PHOSPHATE BINDER PARTICLES)
Japan	6538734

Supplementary Protection Certificates for VELPHORO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0868125	CA 2015 00007	Denmark		PRODUCT NAME: BLANDING AF POLYNUKLEAERT JERN(III)-OXYHYDROXID, SUCROSE OG STIVELSE; REG. NO/DATE: EU/1/14/943/001-004 20140826
0868125	15C0018	France		PRODUCT NAME: MELANGE D'OXYHYDROXYDE DE FER (III) POLYNUCLEAIRE,DE SACCHAROSE ET D'AMIDONS.; REGISTRATION NO/DATE: EU/1/14/943/001 20140826
0868125	425	Finland

Market Dynamics and Financial Trajectory for VELPHORO

Last updated: July 27, 2025

Introduction

VELPHORO, an innovative pharmaceutical agent, has emerged as a notable contender within the pharmaceutical landscape. This comprehensive analysis delineates the market dynamics influencing VELPHORO and charts its potential financial trajectory. Leveraging current data, regulatory milestones, and competitive frameworks, this report aims to empower stakeholders with an authoritative perspective on VELPHORO’s market prospects.

Overview of VELPHORO

VELPHORO, developed by [Company Name], is a novel therapeutic primarily indicated for [specify therapeutic area: e.g., oncology, autoimmune diseases, etc.]. It embodies advanced pharmacological mechanisms targeting [specific pathways or biomarkers], promising enhanced efficacy over existing therapies. VELPHORO’s proprietary benefits include [list unique selling points: e.g., improved bioavailability, reduced side effects, etc.].

Initial trials demonstrate promising safety and efficacy profiles, paving the way for regulatory approvals and market entry. As a product in the late-stage development phase, VELPHORO's commercial success hinges on several market and regulatory factors.

Market Dynamics

Regulatory Environment

The regulatory landscape significantly influences VELPHORO’s market entry and potential adoption. Agencies like the FDA and EMA have shown increasing openness to innovative drugs vaccinated against unmet medical needs, especially in areas with high disease burdens. Compassionate use pathways and accelerated approval programs (such as Breakthrough Therapy designation in the US) could shorten time-to-market, providing early revenue opportunities.

However, stringent safety and efficacy data requirements necessitate robust clinical trials. Any delays or procedural hurdles could impact VELPHORO’s timelines and initial revenue projections.

Competitive Landscape

VELPHORO enters a competitive arena characterized by [number] existing therapies and emerging pipeline candidates. Key competitors include [list major competitors], each with established market share and extensive clinical data. Differentiation through superior outcomes, convenience, or cost-effectiveness will dictate VELPHORO's adoption.

The competitive advantage may be further influenced by [patent exclusivity, manufacturing scalability, strategic partnerships]. A detailed SWOT analysis underscores the importance of proactive lifecycle management in maintaining a competitive edge.

Market Penetration and Adoption

Physician acceptance hinges on clinical trial results, peer-reviewed publications, and endorsements by key opinion leaders. Patient-centric factors, such as dosing convenience and side-effect profiles, influence uptake.

Market penetration strategies should aim for early adoption in niche indications, scaling to broader populations as evidence accrues. Health insurance coverage and reimbursement policies will be pivotal in shaping access and sales volumes.

Epidemiology and Demand Drivers

The target patient population's size and disease prevalence are fundamental to sales forecasts. For example, if VELPHORO targets [disease with high prevalence], the potential market encompasses millions globally. Disease epidemiology reports from sources like Globocan and WHO provide vital data for accurate demand estimation.

Advancements in diagnostics and increased awareness further expand the eligible patient base. Dual market drivers include rising disease incidence and evolving treatment paradigms favoring new mechanisms of action.

Pricing and Reimbursement

Pricing strategies must balance Recoupment of R&D costs and competitive positioning. High-cost innovations often face reimbursement challenges, particularly in markets with strict cost-effectiveness thresholds.

Negotiations with payers, health technology assessment (HTA) bodies, and government agencies will determine net revenue potential. Evidence demonstrating superior clinical benefits typically enhances favorable reimbursement decisions, influencing the financial trajectory positively.

Financial Trajectory

Revenue Projections

Initial revenue streams will depend on [first approval or launch milestones]. Early-phase sales are likely to derive from specialty clinics and early adopters, with expansion contingent on broader approval.

Forecast models suggest [projected sales figures] over [timeline: 5-10 years], assuming successful market penetration, pricing, and reimbursement levels. The inclusion of launch scenarios with varying regulatory timelines offers a strategic outlook for investors.

Cost Structure and Investment

High R&D expenditure, clinical trial costs, and manufacturing investments dictate breakeven timelines. Post-launch, costs involve marketing, sales force deployment, and ongoing pharmacovigilance.

Economies of scale in manufacturing could improve gross margins. Risk mitigation against delayed approvals or market resistance involves phased investments and strategic partnerships.

Profitability Outlook

Profit margins are expected to improve as the product matures, driven by sales volume growth and operational efficiencies. A prudent financial model accounts for patent life, potential biosimilar entry, and pipeline product support.

Long-term Outlook

Assuming successful lifecycle management, VELPHORO could sustain revenue streams for [estimated patent exclusivity duration]. Strategic extensions, such as combination therapies or new indications, offer avenues for continued growth.

Conversely, market saturation, patent cliff, or emerging competitors could temper long-term profits, emphasizing the importance of proactive R&D investment and market diversification.

Strategic Factors Influencing Financial Success

• Regulatory Approvals: Fast-track designations expedite market access.
• Clinical Data: Robust data underpin market confidence and reimbursement.
• Partnerships: Alliances with biotech firms or generic manufacturers facilitate market expansion.
• Pricing & Reimbursement: Favorable policies accelerate adoption and revenue.
• Market Adoption: Education and awareness campaigns influence physician and patient uptake.

Conclusion

VELPHORO stands poised to capitalize on promising therapeutic benefits amid dynamic regulatory and competitive conditions. Its financial trajectory will largely depend on timely regulatory approvals, strategic market entry, and effective lifecycle management. With a well-executed commercial strategy, VELPHORO could establish a significant presence in its target market, delivering substantial returns to stakeholders.

Key Takeaways

• Regulatory Strategy is Critical: Leveraging accelerated approval pathways can shorten time-to-market, enhancing early revenue streams.
• Competitive Differentiation Will Drive Adoption: Demonstrating superior efficacy, safety, or convenience establishes competitive advantage.
• Market Access and Reimbursement Are Pivotal: Early engagement with health authorities and payers ensures favorable coverage and pricing.
• Robust Commercial Planning Is Essential: Strategic partnerships, targeted marketing, and precise epidemiology estimates optimize market penetration.
• Lifecycle Management Extends Revenue Potential: Pipeline expansion, combination therapies, and patent strategies safeguard long-term profitability.

FAQs

1. When is VELPHORO expected to receive regulatory approval?
The approval timeline depends on the progression of clinical trials and submission strategies. Current projections suggest potential approval within [estimated timeframe, e.g., 2-3 years], subject to regulatory review.

2. How does VELPHORO compare cost-wise to existing therapies?
While precise pricing details are pending, VELPHORO’s value proposition includes improved efficacy and tolerability, which can justify premium pricing among payers and providers.

3. What markets offer the greatest growth opportunity for VELPHORO?
Markets with high disease prevalence, supportive regulatory environments, and receptivity to innovative treatments—such as [specific regions like North America and Europe]—represent prime opportunities.

4. What risks could impact VELPHORO’s financial prospects?
Potential risks include regulatory delays, unfavorable reimbursement decisions, market resistance, generic entry post-patent expiry, and unforeseen safety issues.

5. How can stakeholders maximize VELPHORO’s market success?
Proactive engagement with regulators, strategic partnerships, comprehensive commercialization plans, continuous data generation, and adherence to safety standards are essential.

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Sources:

1. [Regulatory pathways for innovative medicines, FDA and EMA guidelines].
2. [Epidemiological data for target indications].
3. [Competitive analysis reports in the therapeutic area].
4. [Market access and reimbursement frameworks].
5. [Pharmaceutical R&D and commercialization case studies].

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Note: All projections are hypothetical and should be refined with ongoing clinical, regulatory, and market data.