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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 twenty-nine patent family members in thirty-five countries.

The generic ingredient in VELPHORO is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are 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 six 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:	129
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
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.

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
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	11,013,761*PED				Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	11,013,762*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
Mexico	2016006916	COMPOSICION FARMACEUTICA, QUE COMPRENDE PARTICULAS DE AGLUTINANTE DE FOSFATO. (PHARMACEUTICAL COMPOSITION, COMPRISING PHOSPHATE BINDER PARTICLES.)
Croatia	P20220318
Croatia	P20240720
Hong Kong	1207298	藥物組合物 (PHARMACEUTICAL COMPOSITIONS)
China	101861146
Guatemala	201000144	" COMPOSICIONES FARMACEUTICAS "

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
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	C00868125/01	Switzerland		PRODUCT NAME: FERRIOXYHYDROXIDUM/SACCHARUM/AMYLA; REGISTRATION NO/DATE: SWISSMEDIC 62986 22.01.2015
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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Velphoro

Overview of Velphoro

Velphoro, also known as sucroferric oxyhydroxide, is a detoxifying agent formulated as chewable tablets, powder, and granules for oral administration. It is primarily indicated for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis[1][3][4].

Market Presence and Expansion

Global Reach

Velphoro has been launched in 51 countries and territories, including the US, EU, and Japan, maintaining a leading position in the global phosphate-binding (PB) market[4].

Recent Licensing Agreements

In 2023, Winhealth Investment gained an exclusive license to register, import, promote, distribute, use, and sell Velphoro in Mainland China, Hong Kong, Macao, and Taiwan. This agreement is expected to significantly expand Velphoro's market presence in these regions[4].

Clinical Efficacy and Safety

Efficacy

Velphoro has demonstrated significant reductions in serum phosphorus levels in patients with end-stage renal disease on dialysis. It has shown comparable efficacy to sevelamer carbonate, a standard treatment for hyperphosphatemia, and has maintained its efficacy across various patient subgroups[3].

Safety Profile

Velphoro is well-tolerated, with a safety profile primarily defined by gastrointestinal adverse events such as diarrhea, which are generally mild and resolve with continued use. Despite a higher discontinuation rate due to gastrointestinal adverse events compared to sevelamer, long-term studies have shown lower discontinuation rates[3].

Financial Performance and Projections

Revenue Contribution

Velphoro is one of the key growth drivers for Vifor Pharma Group and its joint company, Vifor Fresenius Medical Care Renal Pharma (VFMCRP). In 2018, Vifor Pharma reported strong financial performance, with net sales increasing by 22.7% to CHF 1,584.6 million, and EBITDA up by 39.7% to CHF 391.5 million. Velphoro's success contributed significantly to these figures[5].

Market Impact in New Regions

The recent inclusion of Velphoro in category B of the National Reimbursement Drug List in China is expected to have a positive impact on the financial results of the companies involved. This inclusion is anticipated to expand the marketed innovative product portfolio and synergize with other products, such as XinHuoSu and Plendil, thereby enhancing the company's financial performance[4].

Licensing and Partnership Revenue

The licensing agreement between Winhealth Investment and VFMCRP is expected to generate significant revenue through the exclusive rights to promote, distribute, and sell Velphoro in the specified territories. This agreement is seen as a strategic move to capitalize on the growing healthcare market in China[4].

Competitive Landscape

Market Position

Velphoro holds a leading position in the global PB market, particularly due to its efficacy, safety profile, and patient compliance advantages. It has been shown to reduce the number of phosphate-binding pills required by patients by about 50%, and it maintains stable iron parameters and unaffected absorption of oral liposoluble vitamin D[4].

Comparative Advantages

Compared to other phosphate-binding agents, Velphoro offers several advantages, including good safety, reduced hospitalization rates, and alleviation of patients' financial burdens. These factors contribute to its strong market position and potential for continued growth[4].

Financial Trajectory

Historical Performance

The financial performance of Vifor Pharma Group, which includes the revenue from Velphoro, has been strong. In 2018, the group reported a significant increase in net sales and EBITDA, driven in part by the success of Velphoro and other key products[5].

Future Projections

Given the expansion into new markets, such as China, and the inclusion in national reimbursement drug lists, Velphoro is expected to continue contributing positively to the financial performance of the companies involved. The licensing agreements and the drug's clinical and market advantages position it for sustained growth and revenue generation[4].

Impact of Regulatory Approvals

Regulatory Success

Velphoro has received regulatory approvals in multiple regions, including the EU and the US. The recent approval in China and its inclusion in the National Reimbursement Drug List are significant milestones that will drive its market penetration and financial success[3][4].

Compliance and Commercialization

The successful commercialization of Velphoro is supported by the companies' strong expertise and compliant commercialization systems. This ensures efficient market entry and ongoing market presence, which are crucial for maintaining and expanding its financial trajectory[4].

Key Takeaways

• Global Reach: Velphoro is available in 51 countries and territories, with recent expansions into China and other Asian regions.
• Clinical Efficacy: It has demonstrated significant reductions in serum phosphorus levels with a comparable safety profile to standard treatments.
• Financial Performance: Velphoro is a key growth driver for Vifor Pharma Group and VFMCRP, contributing to strong financial results.
• Market Advantages: It offers reduced pill burden, stable iron parameters, and unaffected vitamin D absorption, enhancing patient compliance and safety.
• Future Growth: Expected to continue growing due to new market entries, licensing agreements, and regulatory approvals.

FAQs

Q: What is Velphoro used for?

Velphoro (sucroferric oxyhydroxide) is used for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Q: How does Velphoro compare to other phosphate-binding agents?

Velphoro has shown comparable efficacy to sevelamer carbonate and offers advantages such as reduced pill burden, stable iron parameters, and unaffected vitamin D absorption.

Q: In which regions is Velphoro available?

Velphoro is available in 51 countries and territories, including the US, EU, Japan, and recently in China, Hong Kong, Macao, and Taiwan.

Q: What are the common side effects of Velphoro?

The common side effects of Velphoro include gastrointestinal adverse events such as diarrhea, which are generally mild and resolve with continued use.

Q: How does Velphoro impact patient compliance and quality of life?

Velphoro improves patient compliance by reducing the number of phosphate-binding pills required and maintains stable iron parameters and unaffected vitamin D absorption, thereby improving the quality of life for dialysis patients.