CALCIUM ACETATE - Generic Drug Details

What are the generic sources for calcium acetate and what is the scope of freedom to operate?

Calcium acetate is the generic ingredient in five branded drugs marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Mpp Pharma, Square Pharms, Suven Pharms, Fresenius Medcl Care, Chartwell Molecular, Padagis Us, and Cypress Pharm, and is included in eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Calcium acetate has twenty-three patent family members in sixteen countries.

There are six drug master file entries for calcium acetate. Twenty-three suppliers are listed for this compound.

Summary for CALCIUM ACETATE

International Patents:	23
US Patents:	3
Tradenames:	5
Applicants:	14
NDAs:	18
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	44
Drug Prices:	Drug price trends for CALCIUM ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALCIUM ACETATE
What excipients (inactive ingredients) are in CALCIUM ACETATE?	CALCIUM ACETATE excipients list
DailyMed Link:	CALCIUM ACETATE at DailyMed

See drug prices for CALCIUM ACETATE

See drug sales revenues for CALCIUM ACETATE

Recent Clinical Trials for CALCIUM ACETATE

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

Sponsor	Phase
Peking University People's Hospital	PHASE2
Deakin University	PHASE3
University of Melbourne	PHASE3

See all CALCIUM ACETATE clinical trials

Pharmacology for CALCIUM ACETATE

Drug Class	Blood Coagulation Factor Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for CALCIUM ACETATE

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for CALCIUM ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLYRA	Oral Solution	calcium acetate	667 mg/5 mL	022581	2	2013-12-05
PHOSLO GELCAPS	Capsules	calcium acetate	EQ 169 mg calcium	021160	1	2005-05-31

US Patents and Regulatory Information for CALCIUM ACETATE

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	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001		DISCN	Yes	No
Fresenius Medcl Care	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	9,089,528
Fresenius Medcl Care	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001		DISCN	No	No
Mpp Pharma	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203179-001	Oct 26, 2015	AB	RX	No	No
Amneal Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658-001	Oct 6, 2014		DISCN	No	No

Expired US Patents for CALCIUM ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	6,576,665
Fresenius Medcl Care	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	4,870,105
Fresenius Medcl Care	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	6,875,445
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	4,870,105

International Patents for CALCIUM ACETATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	574331	LIQUID COMPOSITIONS OF CALCIUM ACETATE
European Patent Office	2048948	COMPOSITIONS LIQUIDES D'ACÉTATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)
Poland	2484352
China	101522021
Austria	E547099

Supplementary Protection Certificates for CALCIUM ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
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

Market Dynamics and Financial Trajectory for Calcium Acetate

Last updated: July 28, 2025

Introduction

Calcium acetate is a widely used pharmaceutical and industrial compound, primarily recognized in medical settings for its role in managing hyperphosphatemia, particularly among patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Its commercial appeal extends beyond healthcare into various industrial applications. Understanding the evolving market dynamics and financial trajectory of calcium acetate is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers, as they navigate a landscape shaped by regulatory trends, technological innovations, and global health challenges.

Market Overview and Key Drivers

Pharmaceutical Market Demand

In the pharmaceutical arena, calcium acetate's primary indication is as a phosphate binder used to control serum phosphate levels in CKD and ESRD patients. The increasing prevalence of kidney diseases globally—attributable to aging populations, diabetes, hypertension, and lifestyle factors—steadily boosts demand for calcium acetate-based therapies.

According to the Global Kidney Disease Market report by Fortune Business Insights, the global chronic kidney disease market was valued at approximately USD 65 billion in 2022 and is projected to grow at a CAGR of around 4%. Calcium acetate constitutes a significant component within this landscape, driven by its affordability, efficacy, and well-established safety profile compared to newer phosphate binders.

Growth in Developing Markets

Emerging economies such as China, India, and Brazil exhibit rising healthcare expenditures and increasing CKD incidence. Developing healthcare infrastructure, expanded insurance coverage, and heightened awareness contribute to expanding access to renal care, thereby fueling the demand for calcium acetate. For example, India’s nephrology sector grows at an estimated CAGR of 6%, indirectly amplifying the calcium acetate market.

Industrial and Food Industry Applications

Aside from pharmaceuticals, calcium acetate finds applications as a food additive (E263), in brewing as a yeast nutrient, and in industrial manufacturing processes like adhesives and plastics. While these segments are smaller compared to the pharma sector, they present diversification opportunities, particularly as food safety regulations tighten and demand for natural food additives increases.

Competitive Landscape and Innovation

The market features established players such as Fresenius Medical Care, Baxter International, and generic manufacturers, with a tendency towards commoditization. Nonetheless, ongoing R&D efforts to develop improved phosphate binders with fewer side effects and better compliance profiles influence competitive dynamics. Notably, the innovation of non-calcium-based binders, such as lanthanum carbonate, introduces alternative options, exerting pressure on calcium acetate's market share but also paving pathways for combination therapies.

Regulatory and Reimbursement Environment

Regulatory Approvals

Global regulatory agencies like the U.S. FDA and EMA maintain stringent standards for phosphate binders, emphasizing safety profiles such as minimal calcium load and gastrointestinal tolerability. Calcium acetate traditionally benefits from a well-understood safety profile, facilitating regulatory approvals. However, regulations targeting calcium load and hypercalcemia potential can influence market accessibility.

Pricing and Reimbursement Trends

Healthcare payers increasingly scrutinize drug costs and efficacy. The relatively low cost of calcium acetate, compared to newer binders, bolsters its position, especially in resource-constrained markets. Reimbursement policies, such as Medicare Part D in the U.S., often favor cost-effective treatments, fostering sustained demand.

Market Challenges

Adverse Effects and Safety Concerns

Concerns about calcium accumulation leading to hypercalcemia and vascular calcification pose restrictions. The potential for such side effects has driven clinical discussions and may influence prescribing behaviors, especially for long-term use.

Market Penetration of Alternatives

Non-calcium phosphate binders with fewer mineral-related side effects, such as sevelamer and lanthanum carbonate, continue to gain market share. The emergence of novel agents incorporating binder combinations or alternative mechanisms could challenge calcium acetate's dominance.

Supply Chain Disruptions

Global supply chain disruptions—exacerbated by geopolitical tensions or pandemics—affect raw material availability and manufacturing capacities. Ensuring consistent supply remains vital for maintaining market share and financial stability.

Financial Trajectory and Future Outlook

Revenue Projections

The global calcium acetate market for pharmaceutical applications was valued at approximately USD 250 million in 2021, with expectations of a compound annual growth rate (CAGR) of 3-5% over the next five years. This growth is underpinned by rising CKD prevalence, expanding healthcare infrastructure, and the drug’s cost advantages.

Investment and Mergers & Acquisitions

Industry consolidation continues as major players seek to strengthen their biosimilar and generic portfolios, including calcium acetate production. Large biotech firms may acquire or license formulations, streamlining manufacturing or expanding into new geographic markets.

Innovation and R&D

Research efforts aim to improve pharmacokinetic profiles, reduce side effects, and expand indications. Innovations such as combination therapies with calcium acetate and other phosphate binders or development of novel delivery systems are anticipated to influence future revenues positively.

Emerging Market Opportunities

Developing markets present significant growth opportunities owing to demographic shifts and healthcare expansion. Local manufacturing and strategic partnerships could lead to increased market penetration and revenue growth.

Conclusion

The calcium acetate market is positioned for steady growth driven by demographic trends, expanding healthcare infrastructure, and its established role as a cost-effective phosphate binder. However, challenges related to safety perceptions, competition from newer agents, and supply chain stability persist. Stakeholders must deploy strategies emphasizing innovation, regulatory compliance, and market expansion to capitalize on these opportunities. Monitoring evolving reimbursement policies and advancing formulations are essential components for sustainable financial trajectories.

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Key Takeaways

• Growing CKD Prevalence: Rising incidences worldwide underpin sustained demand for calcium acetate as a phosphate binder.
• Cost-effectiveness Advantage: Its affordability remains a competitive edge in resource-limited markets.
• Innovation Drives Competition: Development of safer, more tolerable phosphate binders poses competitive pressures; innovation in formulations and delivery methods is critical.
• Regulatory Landscape: Stringent safety standards necessitate ongoing compliance and monitoring, influencing market access and profitability.
• Emerging Markets: Developing economies offer significant growth potential; localized manufacturing and strategic partnerships are advantageous.

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FAQs

1. What are the primary medical indications for calcium acetate?
Calcium acetate is mainly used as a phosphate binder to manage hyperphosphatemia in patients with chronic kidney disease and ESRD, helping prevent mineral and bone disorders associated with renal failure.

2. How does calcium acetate compare to other phosphate binders in terms of safety?
Compared to non-calcium-based binders like sevelamer, calcium acetate has a higher potential for causing hypercalcemia and vascular calcification, especially with long-term use. However, its well-understood safety profile and low cost sustain its usage.

3. What are the key factors influencing calcium acetate's market growth?
Demographic patterns leading to increased CKD prevalence, healthcare infrastructure expansion in developing countries, cost advantages, and ongoing clinical research are key growth drivers.

4. How are regulatory trends impacting the calcium acetate market?
Stringent safety and efficacy standards, especially regarding calcium load, influence product approvals and labeling. Regulatory bodies may also incentivize the development of safer alternatives, affecting market share.

5. What future innovations could impact calcium acetate’s market trajectory?
Enhanced formulation delivery systems, combination therapies, and reduced side-effect profiles through pharmaceutical innovation are poised to influence future demand and competitive positioning.

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References

[1] Fortune Business Insights. (2022). Global Kidney Disease Market Report.
[2] MarketWatch. (2023). Phosphate Binders Market Forecast.
[3] U.S. FDA. (2022). Guidance on phosphate binder approvals.
[4] GlobalData. (2022). Renal Care and CKD Market Analysis.