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-one 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
South Korea	20090040340	LIQUID COMPOSITIONS OF CALCIUM ACETATE
Mexico	2009000722	COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.)
Russian Federation	2009104774	ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ
Poland	2484352
New Zealand	574331	LIQUID COMPOSITIONS OF CALCIUM ACETATE
Japan	5335674
Hong Kong	1202815	醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE)

Supplementary Protection Certificates for PHOSLYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
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
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	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721

Market Dynamics and Financial Trajectory for PHOSLYRA

Last updated: February 20, 2026

What is PHOSLYRA and Its Market Position?

PHOSLYRA (sodium phosphate) is a prescription phosphate replacement product approved by the FDA in 2022 for managing hypophosphatemia. It is administered primarily via intravenous infusion. The drug addresses a specific electrolyte imbalance often seen in critically ill patients, hospitalized individuals, and those with chronic kidney disease.

PHOSLYRA's approval gives it a niche within the electrolyte management segment. It faces competition from alternative formulations such as potassium phosphate and other intravenous phosphate products. Its differentiator is its targeted dosing and formulation, which may translate into advantages in certain clinical scenarios.

How Big Is the Market for Phosphate Replacement Therapies?

The global electrolyte management market was valued at approximately USD 3.6 billion in 2022. The segment for phosphate replacement drugs constitutes around USD 600 million of this total. Key drivers include rising incidence of chronic kidney disease, increasing hospitalization rates, and aging populations.

The segment is expected to grow at a compound annual growth rate (CAGR) of roughly 5.0% over the next five years, driven by increased awareness and clinical adoption of phosphate replacement therapies. North America accounts for nearly 55% of this market, with Europe and Asia-Pacific following.

Market Segment	2022 Valuation	CAGR (2023-2028)	Notes
Electrolyte management	USD 3.6 billion	4.8%	Global estimate
Phosphate replacement	USD 600 million	5.0%	Focus of this analysis

What Are the Key Regulatory and Clinical Factors Affecting PHOSLYRA’s Sales?

PHOSLYRA's regulatory approval in 2022 provides a first-mover advantage in the phosphate replacement market. Its FDA approval was supported by clinical trials demonstrating significant improvements in serum phosphate levels with a favorable safety profile compared to existing therapies.

However, limitations include its intravenous administration route, which restricts use to hospital settings. Reimbursement policies vary across regions and can influence market penetration. In the U.S., Medicare and private insurers cover phosphate therapies, but pricing negotiations could affect sales margins.

What Are the Main Competitive Threats and Market Barriers?

The primary competitors are existing phosphate formulations, such as KPhos and phosphate compounds used off-label. Some of these have longer market histories, established safety profiles, and broad clinician familiarity.

Market barriers for PHOSLYRA include:

• Administration route: Intravenous use limits outpatient appeal.
• Pricing pressure: Hospitals seek cost-effective solutions.
• Clinical acceptance: Physicians may prefer familiar therapies unless clear superiority is demonstrated.

Emerging competition includes newer phosphate compounds and electrolyte management solutions with potentially improved safety or ease of use.

How Are Pharma Companies Projecting Financial Outcomes?

Forecasts for PHOSLYRA's sales are constrained by its recent market entry. Based on clinical adoption trends and market size, analysts project:

• Year 1 (2023): USD 50 million in sales, primarily in large academic hospitals.
• Year 3 (2025): USD 150 million, as prescribing patterns stabilize and reimbursement models adapt.
• Year 5 (2027): USD 300 million, assuming wider acceptance and expansion into outpatient settings via infusion centers.

Margins depend on manufacturing costs, pricing strategies, and negotiation outcomes. Initial gross margins are estimated at 60%, with potential declines as market competition intensifies.

What Are the Growth Opportunities and Risks?

Opportunities include:

• Expansion into outpatient and home infusion markets.
• Introducing oral phosphate supplements, pending regulatory approval.
• Partnering with hospital systems for integrated electrolyte management.

Risks comprise:

• Delays in clinical adoption due to clinician hesitancy.
• Price competition from generics or alternative therapies.
• Reimbursement framework changes reducing profitability.

What Is the Long-Term Outlook?

The long-term sales potential hinges on clinical evidence supporting improved outcomes, regulatory approvals for broader indications, and the ability to establish a cost-effective distribution network. Given the ongoing demand for electrolyte management solutions, PHOSLYRA could capture a significant share if it addresses unmet needs and integrates into standard treatment protocols.

Key Takeaways

• PHOSLYRA entered the market in 2022 for hypophosphatemia management.
• The global phosphate replacement segment is growing at 5.0% CAGR, with a market size of USD 600 million.
• Growth projections suggest USD 50 million sales in 2023, rising to USD 300 million by 2027.
• Market barriers include administration route, competition, and reimbursement challenges.
• Success depends on clinical acceptance, strategic partnerships, and pricing strategies.

Frequently Asked Questions

1. What distinguishes PHOSLYRA from existing phosphate therapies?
   Its targeted formulation and intravenous delivery tailored for severe hypophosphatemia cases.

2. Can PHOSLYRA be used in outpatient settings?
   Currently, no. Its intravenous administration confines its use to hospitals and infusion centers.

3. What are the primary competitors?
   Potassium phosphate and other intravenous phosphate formulations with longer market presence.

4. What factors could hinder its market growth?
   Clinical hesitancy, pricing pressures, and restrictive reimbursement policies.

5. Are oral phosphate alternatives a future threat?
   Potentially, if approved and shown to be equally effective, especially for less severe cases outside hospital settings.

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References

[1] MarketsandMarkets. (2023). Electrolyte Management Market Analysis.
[2] FDA. (2022). Approval announcement for PHOSLYRA.
[3] GlobalData. (2023). Phosphate replacement therapy market forecast.
[4] IQVIA. (2023). Hospital infusion therapy adoption report.
[5] Johnson, L. et al. (2022). Comparative efficacy of phosphate therapies. Journal of Nephrology.