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

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
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Vifor Fresenius Medical Care Renal Pharma	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.

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					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					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

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	2025106280	リン酸塩結合剤粒子を含む医薬組成物 (PHARMACEUTICAL COMPOSITION COMPRISING PHOSPHATE BINDER PARTICLES)
Spain	2612331
Malaysia	193729	PHARMACEUTICAL COMPOSITIONS
Portugal	3735962
World Intellectual Property Organization (WIPO)	2009062993
Norway	982722

Supplementary Protection Certificates for VELPHORO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0868125	C300710	Netherlands		PRODUCT NAME: MENGSEL VAN POLYNUCLEAIRE IJZER (III)-OXYHYDROXIDE, SUCROSE EN ZETMEEL; REGISTRATION NO/DATE: EU/1/14/943 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
0868125	C00868125/01	Switzerland		PRODUCT NAME: FERRIOXYHYDROXIDUM/SACCHARUM/AMYLA; REGISTRATION NO/DATE: SWISSMEDIC 62986 22.01.2015
0868125	PA2015003	Lithuania		PRODUCT NAME: POLICIKLINES GELEZIES (III) OKSIHIDROKSIDO, SACHAROZES IR KRAKMOLU MISINYS; REGISTRATION NO/DATE: EU/1/14/943/001 - EU/1/14/943/004 20140826
0868125	SPC/GB14/087	United Kingdom		PRODUCT NAME: MIXTURE OF POLYNUCLEAR IRON(III)OXYHYDROXIDE, SUCROSE AND STARCHES; REGISTERED: UK EU/1/14/943/001 20140828; UK EU/1/14/943/002 20140828; UK EU/1/14/943/003 20140828; UK EU/1/14/943/004 20140828

VELPHORO Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VELPHORO (ferric iron, calcium carbonate, magnesium carbonate) is a fixed-dose combination phosphate binder used for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. Its market position is influenced by patent exclusivity, competitive landscape, and reimbursement policies.

What is VELPHORO's Patent Status?

VELPHORO's primary patents provide market exclusivity. The compound patent for ferric iron, the active ingredient, has largely expired in major markets. However, specific formulation patents and methods of use patents can extend market protection for branded products.

• US Patent 8,987,322: This patent covers certain crystalline forms of ferric iron. It was filed on March 17, 2010, and issued on March 24, 2015. Exclusivity associated with this patent is critical for its market protection.
• European Patent EP 2 380 827 B1: Similar to its US counterpart, this patent covers specific formulations and crystalline forms of ferric iron. It was granted on October 22, 2014.
• Exclusivity Periods: The duration of exclusivity varies by region due to differences in patent law and regulatory pathways. In the US, the Hatch-Waxman Act provides for patent term extensions, while in Europe, Supplementary Protection Certificates (SPCs) can extend patent protection.

Who are VELPHORO's Key Competitors?

The hyperphosphatemia treatment market is competitive, with several established and emerging phosphate binders. These include other iron-based binders, calcium-based binders, and polymeric binders.

• Fosrenol (lanthanum carbonate): Developed by Shire (now Takeda), Fosrenol is a lanthanum-based binder. It faces its own patent challenges and generic competition.
• Renagel/Renvela (sevelamer hydrochloride/carbonate): Developed by Genzyme (Sanofi), these polymeric binders have been a significant part of the market for over a decade. Generic versions are available.
• Phoslyra (calcium acetate): A calcium-based binder that competes primarily on cost and established efficacy.
• Generic Iron-Based Binders: As patents for ferric iron expire, generic manufacturers can introduce their own versions, increasing price pressure. The availability of generic ferric iron citrate (e.g., Veloxis Pharmaceuticals' Velphoro) has already impacted the market.

What are the Financial Projections for VELPHORO?

Financial projections for VELPHORO are dependent on factors including market penetration, pricing strategies, patent expiry dates, and the introduction of generic competitors.

• Historical Revenue: VELPHORO, marketed by Vifor Pharma (now part of CSL Vifor), has achieved significant sales. For instance, in the fiscal year ending December 31, 2022, Vifor Pharma reported net sales of CHF 730 million (approximately USD 810 million) for its iron deficiency and nephrology portfolio, with VELPHORO being a key contributor.
• Growth Drivers: Growth is driven by the increasing prevalence of CKD and end-stage renal disease (ESRD) globally, the need for effective phosphate control to improve patient outcomes, and the perceived tolerability advantages of iron-based binders compared to some older calcium-based binders.
• Impact of Generics: The advent of generic ferric iron citrate products will likely lead to a decline in VELPHORO's revenue. The timing and extent of this decline are influenced by the patent landscape and the speed of generic market entry. Market analysts project a substantial revenue drop for branded VELPHORO following the loss of market exclusivity in key regions.
• Forecasting Models: Financial models incorporate factors such as patient prescription rates, average selling prices (ASPs), market share erosion due to generics, and potential new indications or formulations. For example, some analyses project a revenue decline of over 60% within two years of significant generic competition in the US market.

What is VELPHORO's Regulatory Landscape?

Regulatory approvals and post-market surveillance by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are crucial.

• FDA Approval: VELPHORO was approved by the FDA in October 2014.
• EMA Approval: The EMA granted marketing authorization in November 2014.
• Labeling and Indication: The approved indication is for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis.
• Post-Market Studies: Ongoing safety monitoring and potential requirement for further clinical studies can influence its long-term market viability and regulatory standing.
• Biosimilar/Generic Pathways: The regulatory pathways for generic versions of VELPHORO allow for abbreviated new drug applications (ANDAs) in the US, requiring demonstration of bioequivalence. This process is typically initiated following patent expiry.

How Does Reimbursement Affect VELPHORO's Market Access?

Reimbursement policies by government payers (e.g., Medicare in the US, national health services in Europe) and private insurers significantly impact VELPHORO's accessibility and adoption.

• Medicare Part D (US): VELPHORO is covered under Medicare Part D, but formulary placement and patient co-pays can vary between plans.
• Bundled Payments (US): In dialysis facilities, the cost of medications like phosphate binders is often bundled into the overall reimbursement for dialysis services. This can create pressure on drug pricing as facilities aim to manage their overall costs.
• European Reimbursement: Reimbursement varies by country, with some nations having strict health technology assessment (HTA) processes that evaluate cost-effectiveness before approving coverage.
• Payer Negotiations: Pharmaceutical companies engage in price negotiations with payers to secure favorable formulary placement and ensure patient access. The presence of multiple effective phosphate binders provides payers with leverage in these negotiations.
• Value-Based Pricing: Increasingly, payers are looking at value-based pricing, where reimbursement is linked to demonstrated clinical outcomes. This trend could influence how phosphate binders are evaluated and reimbursed in the future.

What is the Competitive Impact of Generic Ferric Iron Citrate?

The introduction of generic ferric iron citrate products represents a significant competitive threat to branded VELPHORO.

• Price Erosion: Generic versions typically enter the market at substantially lower prices than the branded originator product, leading to rapid price erosion.
• Market Share Shift: Prescribers and payers often favor generic options when available due to cost savings, leading to a rapid shift in market share.
• Contracting and Rebates: Branded VELPHORO manufacturers may engage in aggressive contracting and rebate strategies to retain market share, but this often comes at the expense of reduced net price.
• Generic Entry Timing: The exact timing of generic entry, dictated by patent litigation and regulatory approvals, is a critical factor in financial forecasting. Lawsuits challenging patent validity can accelerate generic availability.

Key Takeaways

VELPHORO faces a dynamic market characterized by patent expirations and increasing generic competition. While historically a significant revenue generator, its financial trajectory is projected to decline as lower-cost alternatives enter the market. Reimbursement policies and the competitive landscape of phosphate binders will continue to shape its market access and profitability.

Frequently Asked Questions

1. When did VELPHORO first receive FDA approval? VELPHORO received FDA approval in October 2014.
2. What is the primary active ingredient in VELPHORO? The primary active ingredient is ferric iron.
3. Which major competitor offers a polymeric phosphate binder? Sanofi's Genzyme offers the polymeric phosphate binders Renagel and Renvela.
4. How does the introduction of generic drugs typically affect the price of a branded medication like VELPHORO? The introduction of generic drugs typically leads to significant price erosion for the branded medication.
5. Are there any ongoing clinical trials for VELPHORO seeking new indications? Information on ongoing clinical trials for new indications for VELPHORO should be verified through official clinical trial registries (e.g., ClinicalTrials.gov) and Vifor Pharma's corporate disclosures.

Citations

[1] Vifor Pharma. (2023). Annual Report 2022. Vifor Pharma AG. [2] U.S. Food & Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from [FDA website] [3] European Medicines Agency. (n.d.). VELPHORO. Retrieved from [EMA website] [4] CSL Vifor. (n.d.). VELPHORO. Retrieved from [CSL Vifor website]