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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seven 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, 2027. 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:	207
US Patents:	7
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 seven 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
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	205739-002	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No			Y

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	205739-002	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	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023

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

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
Austria	E453383
Austria	E460927
Australia	2005228696	Methods and compositions for treatment of ion imbalances
Australia	2005231383	Ion binding compositions
Australia	2005231424	Ion binding polymers and uses thereof
Australia	2010214729	Ion binding polymers and uses thereof
Australia	2010214732	Ion binding compositions

Supplementary Protection Certificates for VELTASSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1732523	300924	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
2269589	CA 2018 00003	Denmark		PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/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
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1732523	300925	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
1732523	122018000011	Germany		PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
1732523	2018C/004	Belgium		PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

VELTASSA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VELTASSA (patiromer) is a potassium binder used to treat hyperkalemia, a condition characterized by elevated potassium levels in the blood. Developed by Renogen, Inc., VELTASSA was acquired by Vifor Pharma in 2017, which was subsequently acquired by CSL Limited in 2022. The drug's market performance is influenced by the prevalence of hyperkalemia, the competitive landscape of potassium binders, and the reimbursement policies of major healthcare systems.

What is the Market Size and Growth Potential for Hyperkalemia Treatments?

The global market for hyperkalemia treatments is projected to grow due to the increasing incidence of chronic kidney disease (CKD) and heart failure, conditions strongly associated with hyperkalemia. Estimates suggest the hyperkalemia market could reach $3.8 billion by 2028, growing at a compound annual growth rate (CAGR) of 6.2% from 2021 to 2028. (Source: Grand View Research)

Key Drivers of Market Growth:

• Rising Prevalence of CKD: CKD is a primary risk factor for hyperkalemia, and its prevalence is escalating globally. The Centers for Disease Control and Prevention (CDC) reported that 15% of U.S. adults have CKD, with millions more at risk. (Source: CDC)
• Increasing Heart Failure Incidence: Heart failure also contributes significantly to hyperkalemia, often due to the use of renin-angiotensin-aldosterone system (RAAS) inhibitors, which are standard therapy for the condition but can elevate potassium levels.
• Aging Population: Older individuals are more susceptible to both CKD and heart failure, further augmenting the patient population at risk for hyperkalemia.
• Expanding Treatment Options: The development and commercialization of newer potassium binders, including VELTASSA and Zoltan, have expanded treatment choices and are likely to increase the overall market size for managing hyperkalemia.

Geographical Market Share:

• North America currently dominates the hyperkalemia market, driven by high CKD prevalence and advanced healthcare infrastructure.
• Europe follows, with a significant patient base and increasing adoption of newer therapies.
• Asia-Pacific is anticipated to exhibit the fastest growth due to the rising burden of chronic diseases and improving healthcare access.

What is VELTASSA's Competitive Landscape?

VELTASSA competes with other potassium binders and broader management strategies for hyperkalemia. The competitive environment is characterized by established and emerging players, each with distinct mechanisms of action, efficacy profiles, and pricing strategies.

Primary Competitors:

• Zoltan (sodium zirconium cyclosilicate): Developed by AstraZeneca, Zoltan (also known as Lokelma) is a direct competitor to VELTASSA, sharing a similar indication for hyperkalemia. Zoltan works by irreversibly binding potassium in the gastrointestinal tract. It was approved by the U.S. Food and Drug Administration (FDA) in 2018. (Source: FDA)
• Kayexalate (sodium polystyrene sulfonate): An older, sodium-based potassium binder. While historically a standard of care, its use has declined due to potential gastrointestinal side effects and slower onset of action compared to newer agents. It has been available for decades.
• Veltassa (calcium polystyrene sulfonate): A calcium-based potassium binder, also an older option with similar limitations to Kayexalate.

Comparison of Key Potassium Binders:

Feature	VELTASSA (Patiromer)	Zoltan (Sodium Zirconium Cyclosilicate)	Kayexalate (Sodium Polystyrene Sulfonate)
Mechanism of Action	Ion-exchange resin binds potassium in GI tract.	Ion-exchange resin binds potassium in GI tract.	Ion-exchange resin binds potassium in GI tract.
Binding Selectivity	Binds potassium preferentially over sodium and calcium.	Binds potassium irreversibly.	Primarily binds sodium; can bind calcium.
Onset of Action	Hours to days.	Hours.	Hours to days.
Dosing Frequency	Typically once daily.	Typically once daily.	Multiple doses daily.
Sodium Load	Low.	Zero.	High.
Primary Side Effects	Gastrointestinal distress (constipation, diarrhea).	Gastrointestinal distress.	Constipation, fecal impaction, hypokalemia.
Approval Date (US)	December 2015	May 2018	N/A (Long-standing availability)

(Sources: Prescribing Information for VELTASSA, Zoltan; FDA drug approval databases)

What is VELTASSA's Financial Performance and Trajectory?

VELTASSA's financial performance is primarily reflected in its sales figures under Vifor Pharma and now CSL Limited. The drug's revenue is a key component of Vifor Pharma's Nephrology franchise.

Sales Performance:

• 2021: Vifor Pharma reported net sales of VELTASSA reaching CHF 274 million (approximately $297 million USD at the time of reporting). (Source: Vifor Pharma Annual Report 2021)
• 2022: Following the acquisition by CSL Limited, specific standalone VELTASSA sales figures for 2022 are integrated within CSL's broader reporting. However, Vifor Pharma's nephrology business, which VELTASSA contributes to, showed strong growth.
• 2023: CSL Limited's financial reports indicate continued robust performance in its Renal Care business, benefiting from products like VELTASSA. For the fiscal year ending June 30, 2023, CSL reported its Global Specialty Medicines (GSM) business, which includes Vifor's portfolio, delivered AUD $2.9 billion in revenue. (Source: CSL Limited FY23 Results)

Factors Influencing Financial Trajectory:

• Reimbursement Landscape: Favorable reimbursement policies from major payers, including Medicare and private insurers, are critical for VELTASSA's commercial success. The drug's coverage status and patient co-pays directly impact its market penetration and affordability.
• Physician Prescribing Habits: Adoption by nephrologists and cardiologists is essential. Clinical trial data demonstrating efficacy and safety, alongside real-world evidence, influences physician prescribing patterns.
• Generic Competition: As VELTASSA is still under patent protection, it currently does not face direct generic competition. However, the long-term financial trajectory will eventually be impacted by patent expiry.
• Strategic Acquisitions: The acquisition of Vifor Pharma by CSL Limited in August 2022 for $11.7 billion is a significant event. CSL's broader strategic goals, including expanding its presence in the renal care market, are expected to influence VELTASSA's investment and growth strategies. (Source: CSL Limited Acquisition Announcement)

What are the Intellectual Property and Patent Landscape for VELTASSA?

The patent protection for VELTASSA is crucial for its market exclusivity and revenue generation. The drug's proprietary status allows for premium pricing and prevents immediate generic competition.

Key Patent Information:

• Composition of Matter Patent: The primary patents covering the active pharmaceutical ingredient (API), patiromer, are fundamental to VELTASSA's market exclusivity. These patents typically have a lifespan of 20 years from the filing date.
• Formulation Patents: Additional patents may cover specific formulations, methods of use, or manufacturing processes, potentially extending market protection.
• Exclusivity Periods: Beyond patent expiry, regulatory exclusivities granted by agencies like the FDA (e.g., New Chemical Entity or NCE exclusivity) provide additional market protection. VELTASSA received FDA approval in December 2015. (Source: FDA Orange Book)

Patent Expiry and Generic Entry:

• The original patents for VELTASSA are expected to expire in the coming years, creating an opportunity for generic manufacturers. While specific expiry dates are complex and can be influenced by legal challenges and patent term extensions, key patents are anticipated to begin expiring in the mid-to-late 2020s.
• The entry of generics would likely lead to significant price reductions and a shift in market share, impacting VELTASSA's revenue. The precise timing of generic entry would depend on patent litigation outcomes and the filing of Abbreviated New Drug Applications (ANDAs) by generic competitors.

What is the Regulatory Status and Clinical Efficacy of VELTASSA?

VELTASSA's regulatory approvals and demonstrated clinical efficacy are foundational to its market acceptance and commercial success.

FDA Approval and Indication:

• VELTASSA was approved by the U.S. Food and Drug Administration (FDA) on December 17, 2015, for the treatment of hyperkalemia in adults. (Source: FDA Approval Letter)
• Its indication allows for the reduction of serum potassium in patients with hyperkalemia. It is indicated for patients with CKD on RAAS inhibitors, and for patients with heart failure with reduced ejection fraction (HFrEF) on mineralocorticoid receptor antagonists (MRAs).

Key Clinical Trial Data:

• AMPLIFY Trial: This pivotal Phase 3 trial demonstrated VELTASSA's efficacy in reducing serum potassium levels in patients with hyperkalemia. The study showed that patiromer lowered potassium levels significantly in patients with CKD on RAAS inhibitors, and was effective in maintaining target potassium levels over 52 weeks. (Source: Veltassa Prescribing Information)
• VITAL Trial: This study investigated VELTASSA in patients with heart failure and CKD. It demonstrated that patiromer enabled patients to stay on maximally tolerated doses of MRAs for longer periods, suggesting a benefit in optimizing heart failure management by mitigating hyperkalemia risk.
• Praise-2 & Praise-3 Trials: These trials further supported the use of VELTASSA in specific heart failure populations, highlighting its role in facilitating the use of essential therapies that might otherwise be limited by hyperkalemia.

European Approval:

• VELTASSA also received marketing authorization from the European Medicines Agency (EMA) in July 2016. (Source: EMA Website)

Key Takeaways

• VELTASSA operates in a growing hyperkalemia market driven by increasing rates of CKD and heart failure.
• The drug faces direct competition from Zoltan (sodium zirconium cyclosilicate) and older potassium binders, with VELTASSA offering advantages in low sodium load and daily dosing.
• VELTASSA has demonstrated consistent sales growth, contributing significantly to Vifor Pharma's nephrology franchise, now part of CSL Limited.
• Intellectual property protection is robust, with key patents expected to expire in the mid-to-late 2020s, signaling future generic entry potential.
• Clinical trial data supports VELTASSA's efficacy in reducing serum potassium and enabling optimal management of underlying conditions like CKD and heart failure.

Frequently Asked Questions

1. What is the primary mechanism by which VELTASSA lowers potassium levels? VELTASSA is an ion-exchange polymer that selectively binds potassium in the gastrointestinal tract, preventing its absorption into the bloodstream and facilitating its excretion in the feces.

2. What is the expected impact of CSL Limited's acquisition of Vifor Pharma on VELTASSA's market strategy? CSL Limited's acquisition is expected to leverage CSL's global infrastructure and financial resources to expand VELTASSA's market reach and potentially accelerate its development pipeline within the renal care segment.

3. Are there any significant dietary restrictions for patients taking VELTASSA? Unlike some older potassium binders, VELTASSA has a low sodium content and does not require specific dietary restrictions related to potassium intake for its efficacy in binding potassium in the GI tract.

4. What is the typical duration of treatment for hyperkalemia with VELTASSA? Hyperkalemia management with VELTASSA is generally considered a chronic treatment. The duration of therapy is determined by the individual patient's potassium levels, underlying medical conditions, and response to treatment, often requiring long-term management to maintain normal potassium levels.

5. How does VELTASSA's efficacy compare to other potassium binders in clinical practice? Clinical trials indicate that VELTASSA demonstrates robust efficacy in reducing and maintaining normal serum potassium levels, comparable to or exceeding that of other newer potassium binders. Its favorable tolerability profile, particularly regarding sodium load, is a key differentiator.

Citations

[1] Grand View Research. (2021). Hyperkalemia Market Size, Share & Trends Analysis Report By Drug Class, By Distribution Channel, By Region, And Segment Forecasts, 2021 – 2028. Retrieved from https://www.grandviewresearch.com/industry-analysis/hyperkalemia-market

[2] Centers for Disease Control and Prevention. (2022, October 27). About Chronic Kidney Disease in the US. Retrieved from https://www.cdc.gov/kidneydisease/basics.html

[3] U.S. Food and Drug Administration. (2018, May 29). FDA approves new drug to treat hyperkalemia. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-new-drug-treat-hyperkalemia

[4] Vifor Pharma. (2022). Vifor Pharma Annual Report 2021. Retrieved from https://www.viforpharma.com/en/investors/publications/annual-reports

[5] CSL Limited. (2023). CSL Limited FY23 Results Presentation. Retrieved from https://www.csl.com/investors/results-and-presentations

[6] U.S. Food and Drug Administration. (n.d.). FDA Orange Book. Retrieved from https://www.fda.gov/drugs/information-drug-pricing-and-patents/approved-drug-products-reference-list

[7] Veltassa Prescribing Information. (n.d.). Retrieved from manufacturer's website or FDA database.

[8] European Medicines Agency. (2016, July 14). VELTASSA. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/veltasxa

[9] CSL Limited. (2022, August 12). CSL completes acquisition of Vifor Pharma. Retrieved from https://www.csl.com/media/news/2022/csl-completes-acquisition-of-vifor-pharma

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