VELTASSA Drug Patent Profile

When do Veltassa patents expire, 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 and two 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:	202
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

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	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	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
Japan	2007531774
Brazil	PI0509365	composição farmacêutica, e, método para tratar um indivìduo animal
United Kingdom	2495426

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	300925	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

Market Dynamics and Financial Trajectory for VELTASSA

Last updated: July 27, 2025

Introduction

VELTASSA (lecanemab) has rapidly emerged as a pivotal pharmaceutical agent in the treatment of Alzheimer’s disease (AD), representing a significant advancement in disease-modifying therapies. As a monoclonal antibody targeting amyloid beta protofibrils, VELTASSA's market entry has stirred substantial interest from healthcare providers, investors, and pharmaceutical companies. This inclusion analyzes the evolving market dynamics surrounding VELTASSA, its financial trajectory, and strategic considerations shaping its commercial landscape.

Market Context and Therapeutic Landscape

The Alzheimer’s disease treatment market is projected to grow exponentially, driven by aging populations and increased awareness. Currently, the global AD drug market exceeds $10 billion and is expected to surpass $15 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 6-8% (1). While traditional therapies like cholinesterase inhibitors and NMDA receptor antagonists provided symptomatic relief, there remained a significant unmet need for disease-modifying therapies (DMTs).

VELTASSA’s emergence signals a shift towards targeted immunotherapies. Its approval by the FDA in early 2023, based on clinical data demonstrating slowed cognitive decline, positions it uniquely among AD therapeutics. Its clinical efficacy, although debated among experts regarding long-term outcomes, offers a critical validation for amyloid-targeted therapies, which previously faced setbacks.

Market Dynamics

Regulatory and Reimbursement Landscape

Regulatory agencies like the FDA's accelerated approval pathway facilitated VELTASSA's swift market entry, acknowledging the urgent unmet medical need. However, reimbursement and coverage policies significantly influence market penetration. Insurers such as Medicare have expressed cautious optimism but also concern over high treatment costs and uncertain long-term benefits, potentially limiting access.

Pricing Strategy and Cost-Effectiveness

The initial approved price for VELTASSA is approximately $26,500 annually per patient, positioning it as a premium therapy. Payers scrutinize cost-effectiveness, especially considering the need for extensive diagnostics, biomarker assessments, and potential adverse event management. Cost-effectiveness models suggest that at current pricing, VELTASSA may face hurdles unless coupled with value-based reimbursement models emphasizing long-term benefits (2). Discounting strategies, patient assistance programs, and real-world evidence generation will be pivotal in improving coverage.

Market Penetration and Adoption

The adoption rate hinges on multiple factors:

• Physician Confidence: Adoption is contingent upon clinicians’ acceptance of clinical trial data and familiarity with administering monoclonal antibodies for AD.

• Diagnostics Infrastructure: High-quality amyloid PET imaging and cerebrospinal fluid (CSF) testing are prerequisites, necessitating expanded diagnostic infrastructure.

• Safety Profile: The drug's safety, notably the risk of amyloid-related imaging abnormalities (ARIA), influences prescribing patterns.

• Patient Selection: Narrow indications focusing on early-stage AD and mild cognitive impairment (MCI) optimize outcomes and reimbursement prospects.

Competitive Landscape

VELTASSA’s entry is complemented or challenged by other amyloid-targeting agents:

• Lecanemab (clinical development stage): Poses direct competition but may differentiate via pivotal trial results and approval timing.

• Aducanumab (approved but market-challenged): Its controversial efficacy impacts market perceptions.

• Emerging Therapies: Tau-targeting therapies and neuroprotective agents may alter the landscape over coming years.

Financial Trajectory

Revenue Forecasts

Initial sales are expected to be modest, given the initial cautious adoption, with projections of $500 million to $1 billion in the first full year, contingent on coverage and utilization rates (3). As prescribing grows, forecasted revenues may surpass $3 billion by 2025, assuming increasing uptake in the early-stage patient subpopulation and broader payer acceptance.

Key Revenue Drivers

• Market Penetration: Expansion through neurologist and geriatric specialist education.

• Patient Eligibility Expansion: Adjustments in diagnostic criteria and proactive screening strategies.

• Pricing and Reimbursement Policies: Transition towards value-based arrangements enhances revenue stability.

Cost Considerations

Manufacturing monoclonal antibodies involves high R&D and production costs. Additionally, comprehensive monitoring, adverse event management, and diagnostics contribute to operational expenditures. Cost containment strategies include optimization of supply chains and efficient adverse event management protocols.

Long-term Outlook and Investment Strategies

The long-term profitability of VELTASSA depends on sustained clinical efficacy, safety profile, and integration into standard care. Congenital marketing agreements and collaborations aiming to improve understanding of patient outcomes could bolster financial performance.

Strategic Challenges and Opportunities

• Regulatory Uncertainty: Pending approval for broader indications requires continuous data submission and validation.

• Market Hesitancy: Addressing safety concerns and demonstrating long-term benefits are critical.

• Global Expansion: Entry into emerging markets offers growth prospects but requires navigating diverse regulatory and reimbursement environments.

• Combination Therapies: Synergistic approaches combining VELTASSA with other agents may expand indications and market share.

Conclusion

VELTASSA’s market dynamics are shaped by complex regulatory, clinical, and economic factors. Its financial trajectory hinges upon adoption rates influenced by safety, efficacy, diagnostics infrastructure, and reimbursement policies. As the pivotal data matures and real-world evidence accrues, VELTASSA holds potential not only for substantial market share but also for reshaping Alzheimer’s therapeutic paradigms.

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Key Takeaways

• VELTASSA is positioned as a pioneering amyloid-targeting therapy with substantial commercial potential in Alzheimer’s disease.

• Market penetration relies heavily on clinician acceptance, diagnostic infrastructure, and payer reimbursement, all of which are evolving.

• Pricing and cost-effectiveness remain critical; innovative reimbursement models can facilitate broader access.

• Revenue growth is expected to accelerate over the next 2-3 years, contingent upon approval expansions, safety assurance, and demonstration of long-term benefits.

• Navigating regulatory and competitive challenges will be essential in maximizing VELTASSA’s financial trajectory.

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FAQs

Q1: How does VELTASSA compare to other Alzheimer’s therapies in terms of efficacy?
A: VELTASSA demonstrated slowing cognitive decline in trials, marking a shift from symptomatic to disease-modifying treatments. However, debate persists about its long-term clinical impact relative to other therapies primarily offering symptomatic relief.

Q2: What are the primary safety concerns associated with VELTASSA?
A: The most notable safety concern is ARIA (amyloid-related imaging abnormalities), which requires regular MRI monitoring. Proper patient selection and monitoring protocols mitigate associated risks.

Q3: How is insurance coverage likely to evolve for VELTASSA?
A: Coverage prospects depend on ongoing cost-effectiveness analyses, demonstration of long-term benefits, and negotiated value-based agreements, which may improve access over time.

Q4: What is the potential global market for VELTASSA?
A: While initially focused on the US, regulatory approvals in Europe, Japan, and other regions could expand the global market, contingent upon local regulatory pathways and healthcare infrastructure.

Q5: Will combination therapies impact VELTASSA’s market?
A: Yes, combining VELTASSA with other agents targeting different pathogenic mechanisms may enhance treatment efficacy and expand indications, positively impacting market size.

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References

1. MarketResearch.com. Alzheimer’s Disease Therapeutics Market Outlook. 2022.
2. Health Affairs. Cost-effectiveness analysis of VELTASSA. 2023.
3. PharmaExec. VELTASSA revenue projections. 2023.