CALCIUM ACETATE - Generic Drug Details

What are the generic drug 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-one 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:	21
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
University of Melbourne	PHASE3
Ramsay Clinic Albert Road	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	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001		DISCN	No	No
Fresenius Medcl Care	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990		DISCN	Yes	No
Padagis Us	CALCIUM ACETATE	calcium acetate	TABLET;ORAL	091561-001	Apr 13, 2011		DISCN	No	No
Fresenius Medcl Care	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	9,089,528
Heritage Pharms Inc	CALCIUM ACETATE	calcium acetate	TABLET;ORAL	202885-001	Jan 22, 2015	AB	RX	No	No
Chartwell Molecular	CALCIUM ACETATE	calcium acetate	TABLET;ORAL	202420-001	Feb 5, 2013	AB	RX	No	Yes
Invagen Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203135-001	Feb 7, 2013	AB	RX	No	Yes

Expired US Patents for CALCIUM ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl Care	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Medcl Care	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	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 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
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	021160-002	Apr 2, 2001	4,870,105

International Patents for CALCIUM ACETATE

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 CALCIUM ACETATE

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

CALCIUM ACETATE: Market Dynamics and Financial Trajectory

Last updated: April 22, 2026

What products and therapeutic use drive the CALCIUM ACETATE market?

Calcium acetate is a calcium-based phosphate binder used primarily in chronic kidney disease (CKD), where it controls serum phosphate levels to reduce complications of CKD-mineral and bone disorder (CKD-MBD). Its market is shaped by:

• CKD prevalence and dialysis penetration (core demand driver)
• Formulary access and reimbursement in CKD patient segments (payer and health-system policies)
• Substitution dynamics among phosphate binders (sevelamer salts, lanthanum carbonate, iron-based binders, and calcium-based alternatives)
• Drug supply continuity and generic pricing pressure (since calcium acetate is widely available in generic form)

In practice, calcium acetate’s uptake and pricing are most sensitive to payer rules that favor lower-cost binder strategies, and to clinical guideline alignment around target phosphate control and pill burden/tolerability.

How does competition shape pricing and share?

Phosphate binders compete on total cost of therapy, dosing convenience, and comparative clinical guidance. Calcium acetate competes mainly with:

• Calcium-free binders (e.g., sevelamer and lanthanum): often preferred when calcium load or hypercalcemia risk is a concern
• Calcium-containing competitors (e.g., calcium carbonate): substitute within the calcium class is common when budgets tighten
• Emerging binders (notably iron-based approaches in some regions): tend to shift share where they obtain strong payer coverage

Market effect: calcium acetate pricing typically trends toward the low end of the class because it is broadly generic and because treatment decisions in CKD frequently prioritize cost-effective phosphate control across patient tiers. Share is sustained by payer preference for economical options, tempered by clinical selection for patients where calcium burden is not appropriate.

What are the main demand segments?

Demand concentrates in CKD patients who require phosphate binding:

• Dialysis patients (high binder adherence and recurring use)
• Non-dialysis CKD where phosphate management is initiated based on guideline targets and local practice

Demand stability: phosphate binder therapy is chronic and recurring, which tends to produce steady utilization once a patient is established on therapy. Volume can still fluctuate with:

• Dialysis capacity changes
• Guideline adoption cycles
• Payer formulary updates

How do formulary and reimbursement dynamics affect revenue?

Revenue trajectory for calcium acetate is typically governed by:

• Exclusivity end and generic diffusion: once marketed as a brand, the field usually becomes dominated by generics after patent or exclusivity windows end
• Step therapy and prior authorization rules: can affect switching between calcium acetate and non-calcium binders
• Negative and positive formulary rules for calcium load risk: payer policies sometimes restrict calcium-based binders for subsets (e.g., hypercalcemia risk)

Financial implication: even if total binder demand grows with CKD prevalence, the average selling price (ASP) typically compresses over time due to generic competition and periodic tendering.

What is the likely market lifecycle pattern for calcium acetate?

Given calcium acetate’s status as a widely used, typically generic phosphate binder, its market lifecycle usually follows:

1. Brand build phase (initial adoption in phosphate control)
2. Patent/exclusivity rollover and increased generic entry
3. Price compression driven by tendering and channel competition
4. Margin stabilization at lower ASP levels, with revenue growth driven more by volume than price

For investors and R&D planners, this pattern means valuation is more sensitive to:

• volume expansion and retention in dialysis/non-dialysis cohorts
• ability to win or retain payer access
• manufacturing scale and supply cost position

What financial trajectory is typical: revenue, profitability, and risk?

Revenue growth drivers

• Patient prevalence growth in CKD
• Dialysis program continuity and chronic treatment adherence
• Payer procurement cycles that keep calcium acetate on preferred lists when clinically acceptable

Revenue headwinds

• ASP erosion from generic competition
• Switching to non-calcium binders for clinical contraindications or formulary decisions
• Tender outcomes that can shift contracted pricing downward

Profitability and cashflow drivers

• Manufacturing cost discipline (API and excipient sourcing, batch yield, compliance)
• Channel mix (hospital tenders vs retail vs specialty pharmacy)
• Working capital and inventory management due to recurring orders but competitive pricing

Key financial risks

• Regulatory or quality events affecting supply continuity
• Rapid payer switching during formulary resets
• Competitive substitutions within the binder class that can reduce volume share

Where do patents and exclusivity matter for revenue?

Calcium acetate revenue usually does not depend on long-term patent protection in the way newer oncology and biologic assets do. Instead, financial trajectory is dominated by:

• generic availability post-patent expiration
• any remaining method of use, formulation, or jurisdiction-specific protections (where applicable)
• regulatory and data exclusivity tied to specific registration pathways and filings in each country

Because phosphate binders are a mature therapeutic area, the market tends to become price-competitive quickly once generic entry is unlocked.

What do pricing dynamics imply for investors and R&D decisioning?

For a mature generic-like phosphate binder market, the revenue/trajectory playbook typically centers on:

• Defending formulary placement
• Competing on total cost-of-therapy and patient adherence
• Maintaining low-cost, reliable supply
• Minimizing compliance and batch-related downtime
• Targeting reimbursement frameworks where calcium-based options remain preferred

If you are evaluating investment attractiveness, the core question is not whether calcium acetate can gain patients, but whether a supplier can sustain:

• share against generics and substitutes
• ASP levels through tender cycles
• stable margins through manufacturing scale

How do macro and policy factors affect near- to mid-term performance?

Macroeconomic

• inflation impacts manufacturing and logistics costs, often compressed by competitive price pressure
• currency volatility can affect import-dependent supply chains (by region)

Health policy

• dialysis utilization changes are slow-moving but persistent
• formulary tightening can increase substitution away from calcium-based binders in certain cohorts
• value-based procurement and tendering can reset prices on a fixed schedule

What is the most actionable view of trajectory: scenario mapping

Below is a practical trajectory framework used for market sizing and financial planning in mature phosphate binder categories.

Scenario A: Stable formulary access, steady volume

• Price: declines at a slower rate after initial generic erosion
• Revenue: grows mainly with patient volume
• Margin: stable if manufacturing unit costs stay contained

Scenario B: Tender-driven ASP compression

• Price: sharp decline during contract resets
• Revenue: flat to modest growth if volume offsets pricing
• Margin: compresses unless cost position improves

Scenario C: Clinical and reimbursement substitution

• Price: stable or declining
• Revenue: declines in share if payers expand restrictions against calcium-based binders
• Margin: higher risk due to lost volume and less favorable channel mix

What KPIs best forecast CALCIUM ACETATE financial performance?

• Dialysis and CKD patient counts in covered populations
• Formulary status (preferred vs restricted tier)
• Tender outcomes (contracted ASP and volume commitments)
• Switching rates between calcium acetate and competing binders
• Manufacturing yield and compliance events (direct margin impact)
• Inventory turns and chargebacks/returns (channel profitability)

Key Takeaways

• Calcium acetate demand is anchored to chronic CKD phosphate control, with volume tied to dialysis and CKD prevalence.
• Financial performance is dominated by generic competition and procurement-driven ASP compression, with revenue growth typically more volume-led than price-led.
• Market share is sensitive to formulary and payer rules, especially around calcium load risk and step therapy use.
• The most decisive financial levers are supply cost position, contract outcomes, and retention of formulary status amid substitution to calcium-free binders.

FAQs

1. Is calcium acetate’s market growth primarily volume-driven or price-driven?
   Primarily volume-driven; price usually compresses due to generic competition and tendering.

2. What main competitors pressure calcium acetate pricing and share?
   Other phosphate binders in the CKD class, especially calcium-free binders and calcium-based alternatives.

3. How do dialysis and non-dialysis CKD cohorts differ for revenue planning?
   Dialysis patients typically produce more stable recurring utilization; non-dialysis cohorts depend more on guideline adoption and payer initiation criteria.

4. What factor most affects profit margins for calcium acetate suppliers?
   Manufacturing cost position and supply reliability, because pricing faces frequent downward pressure.

5. Does patent protection meaningfully shape long-term revenue for calcium acetate?
   Generally less than for patent-protected specialty drugs; revenue is mostly shaped by generic diffusion and formulary access rather than long exclusivity cycles.

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References

1. KDIGO. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements. 2017.
2. US FDA. Drug Approval Packages and information for calcium acetate products (labeling and approval history). U.S. Food and Drug Administration.