PATIROMER SORBITEX CALCIUM - Generic Drug Details

What are the generic drug sources for patiromer sorbitex calcium and what is the scope of patent protection?

Patiromer sorbitex calcium is the generic ingredient in one branded drug marketed by Vifor Pharma and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Patiromer sorbitex calcium has one hundred and ninety-eight patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for PATIROMER SORBITEX CALCIUM

International Patents:	198
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PATIROMER SORBITEX CALCIUM
DailyMed Link:	PATIROMER SORBITEX CALCIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PATIROMER SORBITEX CALCIUM

Constraining patent/regulatory exclusivity:

8,337,824

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.

Pharmacology for PATIROMER SORBITEX CALCIUM

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

Paragraph IV (Patent) Challenges for PATIROMER SORBITEX CALCIUM

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 PATIROMER SORBITEX CALCIUM

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	205739-004	Oct 2, 2023		RX	Yes	No	8,889,115
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No	8,282,913		Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No	8,287,847
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes	9,492,476
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	8,216,560

Expired US Patents for PATIROMER SORBITEX CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,475,780
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,889,115
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023	10,485,821
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,778,324
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	10,485,821
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,287,847

International Patents for PATIROMER SORBITEX CALCIUM

Country	Patent Number	Title	Estimated Expiration
Finland	3431094
Spain	2720612
Portugal	2269589
San Marino	T201500207
Japan	2007531774
Australia	2012254879	Ion binding polymers and uses thereof

Supplementary Protection Certificates for PATIROMER SORBITEX CALCIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1732523	122018000011	Germany		PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	LUC00094	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	PA2018016	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	SPC/GB19/003	United Kingdom		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721
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

PATIROMER SORBITEX CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Patiromer Sorbitex Calcium (Veltassa)

Introduction

Patiromer sorbitex calcium, marketed under the brand name Veltassa, is a significant addition to the treatment arsenal for hyperkalemia, a condition characterized by elevated serum potassium levels. This article delves into the market dynamics and financial trajectory of Veltassa, highlighting its regulatory approvals, clinical efficacy, market positioning, and financial implications.

Regulatory Approvals

Veltassa has received regulatory approvals in several key markets. In the United States, it was approved by the FDA on October 21, 2015, for the treatment of hyperkalemia in adults, with a limitation that it should not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action[5].

In the European Union, Veltassa was approved by the European Medicines Agency (EMA) in July 2017 for the same indication[1]. These approvals have been crucial in establishing Veltassa as a viable treatment option globally.

Clinical Efficacy

The clinical efficacy of Veltassa has been demonstrated through several pivotal trials. The OPAL-HK trial and other phase III studies have shown that Veltassa effectively reduces serum potassium levels in patients with hyperkalemia, particularly those with chronic kidney disease (CKD) and those on renin-angiotensin-aldosterone system inhibitors (RAASi)[3][4].

Veltassa works by binding potassium ions in the gastrointestinal tract, primarily in the colon, and facilitating their excretion through feces. This mechanism has been shown to maintain reduced serum potassium levels over extended treatment periods, up to 52 weeks in some studies[5].

Market Positioning

Veltassa occupies a unique niche in the treatment of hyperkalemia, particularly for patients who cannot tolerate optimal doses of RAAS inhibitors due to hyperkalemia. Clinicians have noted that Veltassa is beneficial for cardiac and renal patients, reducing the need for hospitalizations and emergency department visits[3].

The drug's place in therapy is distinct from other treatments, as it does not require immediate action and is more suited for long-term management of hyperkalemia. This positioning helps in differentiating Veltassa from emergency treatments like insulin/glucose or beta-2 agonists.

Patient Population and Demand

The demand for Veltassa is driven by the prevalence of hyperkalemia, especially among patients with CKD and those on RAAS inhibitors. The patient population includes individuals with chronic conditions who require ongoing management of their potassium levels to prevent complications such as cardiac arrhythmias and muscle weakness.

Given the chronic nature of these conditions, the demand for Veltassa is likely to be consistent and growing, as more patients are diagnosed and treated for hyperkalemia.

Pricing and Reimbursement

The pricing of Veltassa varies by region and is influenced by reimbursement policies. In many countries, Veltassa is covered under national health insurance programs or private insurance plans, which helps in making the treatment accessible to a broader patient population.

For instance, in Canada, the reimbursement review by CADTH considered the clinical and economic evidence to support the inclusion of Veltassa in public drug programs[3].

Financial Performance

The financial performance of Veltassa has been positive since its approval. The drug has generated significant revenue for its manufacturer, Vifor Pharma, and has contributed to the company's growth in the pharmaceutical sector.

Revenue Growth

Veltassa has shown steady revenue growth since its launch. The drug's unique mechanism of action and its approval in multiple markets have contributed to its commercial success.

Market Share

Veltassa has captured a significant share of the hyperkalemia treatment market, particularly in the segment focused on long-term management. Its market share is expected to continue growing as more clinicians adopt it as a standard treatment option.

Competitive Landscape

The competitive landscape for hyperkalemia treatments includes other potassium binders like sodium polystyrene sulfonate (SPS) and newer entrants such as lokelma (sodium zirconium cyclosilicate). However, Veltassa's distinct mechanism of action and its efficacy in reducing serum potassium levels over an extended period set it apart from competitors.

Differentiation

Veltassa's differentiation lies in its ability to bind potassium ions in the colon, reducing the risk of gastrointestinal side effects associated with other potassium binders. This unique profile has helped Veltassa to carve out a niche in the market.

Future Outlook

The future outlook for Veltassa is promising, driven by several factors:

Expanding Patient Population

The increasing prevalence of CKD and the growing use of RAAS inhibitors are expected to expand the patient population requiring hyperkalemia management.

Ongoing Clinical Research

Continued clinical research and real-world evidence studies are likely to further establish Veltassa's efficacy and safety profile, potentially expanding its indications and patient base.

Market Expansion

Veltassa is expected to enter new markets as regulatory approvals are obtained in additional countries, further boosting its revenue and market share.

Key Takeaways

• Regulatory Approvals: Veltassa has been approved in the US, EU, and other regions for the treatment of hyperkalemia.
• Clinical Efficacy: Veltassa effectively reduces serum potassium levels in patients with hyperkalemia, particularly those with CKD.
• Market Positioning: Veltassa is positioned for long-term management of hyperkalemia, differentiating it from emergency treatments.
• Pricing and Reimbursement: Covered under various insurance programs, making it accessible to a broader patient population.
• Financial Performance: Steady revenue growth and significant market share in the hyperkalemia treatment segment.
• Competitive Landscape: Unique mechanism of action sets it apart from other potassium binders.
• Future Outlook: Promising due to expanding patient population, ongoing clinical research, and market expansion.

FAQs

What is the primary indication for Veltassa?

Veltassa is indicated for the treatment of hyperkalemia in adults.

How does Veltassa work?

Veltassa works by binding potassium ions in the gastrointestinal tract, primarily in the colon, and facilitating their excretion through feces.

Why is Veltassa not used for emergency treatment of hyperkalemia?

Veltassa is not used for emergency treatment due to its delayed onset of action, typically taking several hours to reduce serum potassium levels.

What are the common dosages of Veltassa?

Veltassa is available in doses of 8.4 g, 16.8 g, and 25.2 g, taken once daily as an oral suspension with food.

Are there any significant side effects or interactions associated with Veltassa?

Veltassa can bind other oral medications and may increase calcium absorption, but it is generally well-tolerated with minimal systemic absorption[5].

Sources

1. Australian Public Assessment Report for patiromer sorbitex calcium - Therapeutic Goods Administration.
2. UMMS Standard Charges - University of Maryland Medical System.
3. Patiromer (Veltassa) - Canada's Drug Agency - CADTH.
4. Patiromer Powder for Oral Suspension - Health Canada.
5. Office Director Decisional Memo – NDA 205739 - FDA.