VELTASSA Drug Patent Profile

Which patents cover Veltassa, and when can generic versions of Veltassa launch?

Veltassa is a drug marketed by Vifor Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred patent family members in twenty-seven countries.

The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Veltassa

Veltassa was eligible for patent challenges on October 21, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 29, 2030. This may change due to patent challenges or generic licensing.

There have been two 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 VELTASSA

International Patents:	200
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	13
Drug Prices:	Drug price information for VELTASSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELTASSA
What excipients (inactive ingredients) are in VELTASSA?	VELTASSA excipients list
DailyMed Link:	VELTASSA at DailyMed

See drug prices for VELTASSA

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

NDA:

205739

Dosage:

POWDER;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 VELTASSA

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

Sponsor	Phase
University of California, Irvine	Phase 4
NHS Greater Glasgow and Clyde	Phase 4
University of Glasgow	Phase 4

See all VELTASSA clinical trials

Pharmacology for VELTASSA

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

Paragraph IV (Patent) Challenges for VELTASSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VELTASSA	for Oral Suspension	patiromer sorbitex calcium	8.4 g, 16.8 g and 25.2 g	205739	2	2019-10-21

US Patents and Regulatory Information for VELTASSA

VELTASSA is protected by eight 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 Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No				Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No

Expired US Patents for VELTASSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015

International Patents for VELTASSA

When does loss-of-exclusivity occur for VELTASSA?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Germany

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

Mexico

Netherlands

Norway

Poland

Portugal

San Marino

Slovenia

South Korea

Spain

United Kingdom

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 VELTASSA around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1116850
Japan	2021095421	高血圧症及び高カリウム血症を治療するためのカリウム結合剤 (POTASSIUM BINDER FOR TREATING HYPERTENSION AND HYPERKALEMIA)
Japan	2019065030	架橋陽イオン交換ポリマー、組成物、および高カリウム血症の治療における使用 (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Japan	6475624
Canada	2558029	POLYMERES DE LIAISON IONIQUE ET LEURS UTILISATIONS (ION BINDING POLYMERS AND USES THEREOF)
Denmark	3219312

Supplementary Protection Certificates for VELTASSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
1732523	2018C/004	Belgium		PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2365988	PA2018004	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	C 2019 004	Romania		PRODUCT NAME: PATIROMER SORBITEX SARE DE CALCIU; NATIONAL AUTHORISATION NUMBER: EU/1/17/1179/001-009; DATE OF NATIONAL AUTHORISATION: 20170719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1179/001-009; DATE OF FIRST AUTHORISATION IN EEA: 20170719
1732523	300924	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
2957286	2018041	Norway		PRODUCT NAME: PATIROMERSORBITEKSKALSIUM; REG. NO/DATE: EU/1/17/1179 20170809

Market Dynamics and Financial Trajectory for Veltassa

Introduction

Veltassa, developed by Relypsa and later acquired by Vifor Pharma (now part of CSL Vifor), is a drug designed to treat hyperkalemia, a condition characterized by high potassium levels in the blood. This article delves into the market dynamics and financial trajectory of Veltassa, highlighting its sales performance, market positioning, and the factors influencing its financial success.

Development and Approval History

Veltassa was initially developed by Amgen and later transferred to Relypsa in 2009 for an upfront cost of $8.2 million. After its approval in 2015, Relypsa partnered with Vifor Fresenius Medical Care Renal Pharma to commercialize the drug outside the U.S. In 2016, Galenica (now Vifor Pharma) acquired Relypsa for $1.5 billion, marking a significant milestone in Veltassa's commercial journey[4].

Sales Performance

Quarterly Sales

Veltassa's sales have shown a mixed trajectory. Initially, the drug experienced slow growth in its early market years. However, its quarterly sales started increasing at a faster rate after the first year. By the fourth year on the market, Veltassa's quarterly sales surpassed $40 million, indicating a strong growth phase[1].

Annual Sales

In 2021, Veltassa's net sales were CHF 114.2 million, which represented a 3.5% decrease from the previous year, or a 1.0% decrease at constant exchange rates (CER). The U.S. market contributed significantly, with net sales amounting to CHF 95.3 million[2].

Comparative Sales Analysis

When compared to other drugs in the non-antimicrobial (non-AM) cohort, Veltassa's sales were notable but not exceptional. The drug's cumulative nine-quarter sales were lower than some of its peers, highlighting the variability in market performance within the cohort[1][3].

Market Dynamics

Competitive Landscape

Veltassa operates in a competitive market for hyperkalemia treatments. Despite its growth, the drug faces competition from other treatments and must continually demonstrate its clinical benefit to maintain market share. The overall comparative added clinical benefit score of Veltassa influences its sales, as drugs with higher scores tend to have higher early market sales[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the pharmaceutical industry, including Veltassa's sales. While the pandemic's effects were not specifically analyzed in the sales data, it is known that patient access to treatments was affected, leading to fluctuations in sales across various pharmaceutical products[1].

Financial Performance

Revenue Growth

Vifor Pharma, the parent company of Veltassa, reported sustained growth in 2021, with net sales increasing by 2.8% to CHF 1,754.2 million. Although Veltassa's sales decreased slightly in 2021, the overall portfolio performance was positive, driven mainly by the iron product portfolio[2].

EBITDA and Profit Margins

The company's EBITDA increased by 4.6% to CHF 602.0 million in 2021, reflecting strong operational performance and cost containment measures. The gross profit margin improved to 63.2%, primarily due to the higher share of sales from injectable iron products[2].

Cash Flow and Financial Position

Vifor Pharma maintained a strong financial position with a net cash position of CHF 453.8 million and an equity ratio of 77.8% at the end of 2021. The cash flow from operating activities increased to CHF +527.4 million, driven by positive developments in net working capital[2].

Strategic Moves and Partnerships

Commercialization Partnerships

Vifor Pharma's partnership with Fresenius Medical Care Renal Pharma for the commercialization of Veltassa outside the U.S. has been crucial for the drug's global reach. Additionally, partnerships in China and Canada for Veltassa and other products have contributed to the company's revenue growth[5].

Acquisitions and Divestments

The acquisition of Relypsa by Galenica in 2016 was a significant strategic move that integrated Veltassa into Vifor Pharma's portfolio. The divestment of non-core manufacturing sites and products has also been part of the company's strategy to focus on high-value assets[2].

Challenges and Opportunities

Clinical Benefit and Sales Correlation

While Veltassa's sales have been influenced by its clinical benefit score, there are exceptions and outliers. The drug's early market sales were lower than expected, but it has since shown growth. This highlights the need for continuous clinical validation and market positioning[1][3].

Market Expansion

The potential for Veltassa to expand into new markets and indications remains a significant opportunity. The drug's approval and commercialization in additional regions, such as China and Canada, have already contributed to its revenue growth[5].

Key Takeaways

• Sales Growth: Veltassa's sales have shown a mixed trajectory, with significant growth after the first year but a slight decline in recent years.
• Market Positioning: The drug operates in a competitive market and must continually demonstrate its clinical benefit to maintain market share.
• Financial Performance: Vifor Pharma's overall financial performance has been strong, driven by its iron product portfolio and strategic partnerships.
• Strategic Moves: Partnerships and acquisitions have been crucial for Veltassa's global reach and revenue growth.
• Challenges and Opportunities: Continuous clinical validation and market expansion are key to Veltassa's future success.

FAQs

What is Veltassa used for?

Veltassa is used to treat hyperkalemia, a condition characterized by high potassium levels in the blood.

Who developed Veltassa?

Veltassa was initially developed by Amgen and later transferred to Relypsa, which was subsequently acquired by Vifor Pharma.

How has Veltassa's sales performance been?

Veltassa's sales have shown growth after the first year on the market, but there was a slight decline in 2021. The drug's quarterly sales have surpassed $40 million in its fourth year on the market.

What factors influence Veltassa's sales?

The drug's sales are influenced by its comparative added clinical benefit score, market competition, and external factors such as the COVID-19 pandemic.

What is the current ownership of Veltassa?

Veltassa is currently owned by CSL Vifor, following the acquisition of Vifor Pharma by CSL Limited.

Last updated: 2024-12-17