PHOSLYRA Drug Patent Profile

When do Phoslyra patents expire, and what generic alternatives are available?

Phoslyra is a drug marketed by Fresenius Medcl Care and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in sixteen countries.

The generic ingredient in PHOSLYRA is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phoslyra

A generic version of PHOSLYRA was approved as calcium acetate by HIKMA on February 26^th, 2008.

Summary for PHOSLYRA

International Patents:	23
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Drug Prices:	Drug price information for PHOSLYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLYRA
What excipients (inactive ingredients) are in PHOSLYRA?	PHOSLYRA excipients list
DailyMed Link:	PHOSLYRA at DailyMed

See drug prices for PHOSLYRA

See drug sales revenues for PHOSLYRA

Recent Clinical Trials for PHOSLYRA

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

Sponsor	Phase
Vifor Fresenius Medical Care Renal Pharma	Phase 3
Fresenius Medical Care North America	Phase 4

See all PHOSLYRA clinical trials

Paragraph IV (Patent) Challenges for PHOSLYRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLYRA	Oral Solution	calcium acetate	667 mg/5 mL	022581	2	2013-12-05

US Patents and Regulatory Information for PHOSLYRA

PHOSLYRA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Medcl Care	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	8,592,480
Fresenius Medcl Care	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	9,089,528
Fresenius Medcl Care	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	8,591,938		Y

International Patents for PHOSLYRA

See the table below for patents covering PHOSLYRA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2658465
Mexico	2009000722	COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.)
Australia	2007275606

Supplementary Protection Certificates for PHOSLYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
2957286	132019000000021	Italy		PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Phoslyra

Introduction

Phoslyra, a proprietary phosphate supplement primarily used to manage hyperphosphatemia in dialysis patients, has garnered attention within the pharmaceutical space due to its unique formulation and clinical utility. As the renal care market expands driven by rising chronic kidney disease (CKD) prevalence globally, understanding Phoslyra’s market dynamics and its financial trajectory becomes crucial for stakeholders. This analysis explores the key factors influencing its market positioning, growth prospects, competitive landscape, regulatory environment, and economic drivers shaping its financial future.

Market Overview and Therapeutic Indication

Phoslyra is indicated for managing hyperphosphatemia, a common complication among patients with end-stage renal disease (ESRD) undergoing dialysis. The global CKD and ESRD populations are expanding at a significant compound annual growth rate (CAGR), propelled by diabetes and hypertension, known primary risk factors [1]. The demand for phosphate binders, the class of drugs to which Phoslyra belongs, correlates directly with the increase in dialysis treatments worldwide.

The oral phosphate binder market was valued at approximately USD 2.4 billion in 2022 and is projected to grow at a CAGR of around 6% through 2030 [2]. Within this space, Phoslyra distinguishes itself via its formulation technology—most notably, its calcium-free, highly soluble composition that permits flexible dosing and improved tolerability [3]. Such features bolster its therapeutic profile, appealing to both nephrologists and patients.

Market Drivers

Several key drivers underpin Phoslyra’s market momentum:

Rising Global CKD and ESRD Burden

The International Society of Nephrology reports that CKD affects over 850 million individuals worldwide, with ESRD requiring renal replacement therapy (RRT) such as dialysis, which in turn necessitates phosphate binders [4]. An aging population, lifestyle factors, and increasing prevalence of diabetes and hypertension intensify this trend.

Enhanced Formulation and Patient Compliance

Phoslyra’s formulation offers improved palatability and ease of administration, potentially leading to better adherence. With the shift towards personalized and patient-centric care, drugs that improve compliance are gaining preference, impacting its market penetration positively [3].

Incipient Regulatory Approvals and Market Expansion

While currently approved in specific regions, efforts toward expanding indications and obtaining regulatory approvals in emerging markets (e.g., Asia-Pacific) are ongoing. These initiatives can significantly expand its available market reach.

Competitive Dynamics

The phosphate binder landscape is competitive, with established players like Fosrenol (lanthanum carbonate), Renvela (sevelamer carbonate), and Alucaps (calcium acetate). Phoslyra’s differentiating features, including its safety profile (lower risk of hypercalcemia and vascular calcification), position it favorably amidst these rivals [5]. The entry of generic versions or biosimilars could influence pricing and market share dynamics over the coming years.

Market Challenges and Risks

Despite favorable drivers, Phoslyra faces notable challenges:

• Pricing and Reimbursement Constraints: In many markets, reimbursement policies for phosphate binders are tightly regulated, affecting sales margins. Negotiations with healthcare payers could impact revenue growth.
• Competitive Pricing Pressure: States of fierce price competition among phosphate binders could suppress profit margins, especially once patent exclusivity wanes.
• Regulatory Barriers: Approval delays or restrictions in key geographies may impede rapid growth. Additionally, evolving safety standards may necessitate post-marketing studies, increasing costs.
• Adherence and Clinical Outcomes: Ensuring long-term adherence remains a challenge. Non-compliance can reduce market penetration and impact licensing agreements.

Financial Trajectory and Revenue Forecasts

Considering the current landscape, Phoslyra’s revenue trajectory hinges on several factors: clinical acceptance, market expansion, competitive positioning, and pricing strategies.

Short-term Outlook (1–3 Years)

In the immediate term, Phoslyra is expected to experience steady growth driven by ongoing clinical adoption in existing markets. Launch activities in emerging regions, supported by regulatory approvals, are anticipated to contribute to incremental sales. Industry analysts project a CAGR of approximately 8% within this period [2].

Medium to Long-term Outlook (4–10 Years)

Over the next decade, Phoslyra’s financial growth could accelerate if expanded indications are approved, and if reimbursement frameworks become more favorable. Its differentiating features—particularly safety and tolerability—may enable premium pricing, enhancing revenue streams. Assuming successful market penetration in Asia-Pacific and Latin America, revenues could potentially reach USD 500–600 million annually by 2030, representing a compound growth rate of approximately 9–10% [6].

Furthermore, evolving dialysis practices, such as home-based therapies and novel drug combinations, may shape its utilization patterns. The potential for new formulations or combination therapies could open additional revenue opportunities.

Regulatory and Patent Landscape

Regulatory approval pathways are crucial determinants of market access. Currently, Phoslyra holds approvals in select regions, including the United States and Europe. Pending and future approvals can serve as catalysts for revenue expansion. Managing patent portfolios, safeguarding intellectual property, and navigating biosimilar threats remain vital for sustaining financial growth.

Competitive and Market Entry Strategies

To optimize its financial trajectory, Phoslyra’s manufacturers should pursue strategic collaborations, such as licensing agreements and joint ventures, to accelerate market penetration. Investing in clinical research to expand its indications and demonstrate added benefits could reinforce its competitive stance.

Key Economic and Policy Considerations

Government policies prioritizing early diagnosis and management of CKD, reimbursement incentives, and healthcare infrastructure development will significantly influence Phoslyra’s uptake. The increasing emphasis on value-based care models aligns with the drug’s ability to improve patient outcomes, potentially unlocking higher reimbursement and procurement agreements.

Conclusion

Phoslyra’s market dynamics are shaped by the rising global burden of CKD, its distinct clinical profile, and strategic positioning relative to competitors. While near-term growth prospects appear favorable, long-term success hinges on regulatory approvals, pricing strategies, and market expansion efforts. Its projected financial trajectory shows promising growth potential, contingent upon successful navigation of competitive and regulatory landscapes.

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Key Takeaways

• The global demand for phosphate binders like Phoslyra is expanding, driven by rising ESRD prevalence and improved treatment modalities.
• Its differentiated formulation and safety profile position it competitively within a crowded market.
• Short-term growth is expected to remain steady, with potential acceleration through geographic expansion and additional indications.
• Market challenges include reimbursement constraints, pricing pressures, and regulatory hurdles, which require proactive management.
• Strategic collaborations, clinical research, and regulatory efforts are pivotal to maximizing Phoslyra’s financial trajectory over the next decade.

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FAQs

1. What distinguishes Phoslyra from other phosphate binders?
Phoslyra is calcium-free, highly soluble, and offers a favorable safety profile with reduced risks of hypercalcemia and vascular calcification, making it suitable for long-term management of hyperphosphatemia.

2. In which markets is Phoslyra currently approved?
Phoslyra has obtained regulatory approval in regions including the US and Europe. Ongoing efforts aim to expand approvals in Asia-Pacific and other emerging markets.

3. What is the outlook for Phoslyra’s sales over the next five years?
Industry projections suggest an 8–10% CAGR, with potential revenues reaching USD 500 million by 2030, driven by geographic expansion and increased clinical adoption.

4. How do reimbursement policies impact Phoslyra’s market penetration?
Reimbursement constraints can limit access and sales, especially in cost-sensitive markets. Effective engagement with payers and evidence of clinical value are crucial for improving coverage.

5. What are the main risks to Phoslyra’s financial growth?
Key risks include regulatory delays, pricing pressures, emergence of biosimilars, and clinical practice shifts that could affect demand. Strategic planning and innovation are essential to mitigate these risks.

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References

[1] Global CKD statistics – International Kidney Foundation.
[2] Market research reports on phosphate binders – Grand View Research, 2022.
[3] Product profile and formulation advantages – Company filings and clinical studies.
[4] CKD prevalence and global burden – International Society of Nephrology, 2022.
[5] Competitive landscape analysis – Pharma Marketwatch, 2023.
[6] Long-term financial projections – Industry analyst consensus, 2023.