EDETATE CALCIUM DISODIUM Drug Patent Profile

When do Edetate Calcium Disodium patents expire, and what generic alternatives are available?

Edetate Calcium Disodium is a drug marketed by Casper Pharma Llc and is included in one NDA.

The generic ingredient in EDETATE CALCIUM DISODIUM is edetate calcium disodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the edetate calcium disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Edetate Calcium Disodium

A generic version of EDETATE CALCIUM DISODIUM was approved as edetate calcium disodium by CASPER PHARMA LLC on May 3^rd, 2023.

Summary for EDETATE CALCIUM DISODIUM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	4,270
DailyMed Link:	EDETATE CALCIUM DISODIUM at DailyMed

Recent Clinical Trials for EDETATE CALCIUM DISODIUM

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

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1

See all EDETATE CALCIUM DISODIUM clinical trials

Pharmacology for EDETATE CALCIUM DISODIUM

Drug Class	Anti-coagulant Lead Chelator
Mechanism of Action	Calcium Chelating Activity Lead Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

US Patents and Regulatory Information for EDETATE CALCIUM DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	EDETATE CALCIUM DISODIUM	edetate calcium disodium	INJECTABLE;INJECTION	216435-001	May 3, 2023		RX	No	Yes

Edetate Calcium Disodium Market Dynamics, Patent Status, FDA Regulation, and Financial Trajectory

Last updated: September 7, 2026

Edetate calcium disodium is a mature, low-volume injectable chelator used primarily for lead poisoning. Its commercial value comes from clinical necessity, limited supplier depth, hospital stocking requirements, and episodic shortage pricing rather than from large prescription volume. The product has no meaningful remaining branded exclusivity, no biosimilar exposure, and limited patent barriers. Public companies generally do not report revenue for edetate calcium disodium separately, so the drug’s financial trajectory must be assessed through demand drivers, supply conditions, procurement economics, and regulatory risk.

What is edetate calcium disodium used for?

Edetate calcium disodium, also known as calcium disodium EDTA or calcium disodium versenate, is an injectable chelating agent. The FDA-approved indication is the treatment of lead poisoning in adults and children, including patients with blood lead concentrations that require chelation therapy.[1]

The drug binds lead and promotes renal elimination. It is administered intravenously or intramuscularly under controlled clinical conditions. The FDA label warns against confusing edetate calcium disodium with disodium EDTA. The latter can produce severe hypocalcemia and has a different clinical risk profile.[1]

Attribute	Edetate calcium disodium
Active ingredient	Calcium disodium edetate
Common names	Edetate calcium disodium, calcium disodium EDTA, CaNa2EDTA
Therapeutic class	Chelating agent
Primary approved use	Lead poisoning
Dosage form	Injectable solution
Common concentration	200 mg/mL
Administration	Intravenous or intramuscular
Primary setting	Hospital, emergency, poison-control-directed care
Generic or branded market	Predominantly generic or legacy branded supply
Biosimilar exposure	None

The product is not a routine outpatient medicine. Demand is linked to poisoning events, occupational exposure, contaminated products, public-health incidents, and the continued diagnosis of severe pediatric lead exposure.

What is the FDA regulatory status of edetate calcium disodium?

Edetate calcium disodium is an established FDA-approved drug with long-standing regulatory status. Its regulatory value is tied to the approved injectable formulation and manufacturing compliance, not to active exclusivity.

The FDA-approved label identifies the product for lead poisoning and sets dosing regimens based on the patient’s age, weight, clinical condition, and blood lead concentration.[1] Treatment is generally coordinated with toxicology specialists or poison control centers.

Is edetate calcium disodium an FDA-approved drug?

Yes. Edetate calcium disodium injection is FDA-approved for lead poisoning. The product is subject to standard requirements for injectable drug quality, sterility, container closure, labeling, and manufacturing controls.

The drug is also included in clinical guidance for severe lead exposure. The Centers for Disease Control and Prevention recommends chelation for selected patients with high blood lead levels, with treatment choice depending on the severity of exposure and clinical circumstances.[2]

Is edetate calcium disodium on the FDA drug shortage list?

The product has experienced supply constraints and shortage concerns in past periods. Injectable chelators are particularly vulnerable because the market is small, production is concentrated, and manufacturers may have limited commercial incentive to maintain redundant capacity. FDA shortage status can change as manufacturing, inventory, and allocation conditions change.[3]

A shortage does not necessarily indicate a long-term demand increase. For edetate calcium disodium, supply interruptions can reflect plant issues, component shortages, quality actions, limited production runs, or supplier decisions.

What patents protect edetate calcium disodium?

No material active patent estate is generally associated with the basic edetate calcium disodium molecule or its legacy injectable product. The compound and its medical use predate the modern pharmaceutical patent strategies used for new chemical entities.

Protection category	Commercial significance
Core compound patent	No meaningful current barrier expected
Original composition patent	Expired or commercially irrelevant
Basic lead-poisoning method patent	No meaningful current exclusivity expected
Injectable formulation patent	Limited likelihood of active blocking rights
Manufacturing patent	Potentially relevant only to a specific process, supplier, or formulation
Pediatric exclusivity	No current commercial significance
Orphan-drug exclusivity	Not the principal market protection
Biosimilar exclusivity	Not applicable

Are there Orange Book patents for edetate calcium disodium?

The product’s commercial market is not generally protected by a current Orange Book patent estate comparable to that of newer branded drugs. Any patent listing must be evaluated against the specific reference product, National Drug Code, and current FDA Orange Book data because listings can differ by approved application and manufacturer.[4]

For market-entry analysis, the key conclusion is that a new applicant would face regulatory and manufacturing hurdles, not a strong composition-of-matter patent barrier.

Does edetate calcium disodium have Paragraph IV risk?

Paragraph IV litigation risk is low. A generic applicant normally uses an abbreviated new drug application and must address the reference product’s patent certifications. Where there are no meaningful unexpired patents listed against the relevant reference product, Paragraph IV litigation is unlikely to be the principal barrier.

The more relevant risks are:

• FDA approval timing
• Injectable manufacturing validation
• Sterility and quality controls
• Limited market size
• Contracting with hospitals and distributors
• Reliable active pharmaceutical ingredient supply
• Inventory economics during non-shortage periods

When does edetate calcium disodium lose exclusivity?

Edetate calcium disodium lost practical exclusivity decades ago. It is a legacy small-molecule injectable with generic competition and no commercially important remaining period of new-drug exclusivity.

Exclusivity type	Current position
New chemical entity exclusivity	Expired
Orphan exclusivity	No meaningful current protection
Pediatric exclusivity	Expired or not commercially determinative
Data exclusivity	Expired
Patent exclusivity	No material current barrier generally associated with the core product
Reference-product market protection	Minimal

The market therefore behaves as a mature essential-drug market rather than as a protected specialty pharmaceutical market.

How large is the edetate calcium disodium market?

The global market is small relative to mainstream hospital injectables and substantially smaller than the markets for oral lead-chelation products. Public market-research estimates vary because analysts may combine calcium disodium EDTA with disodium EDTA, succimer, dimercaprol, or the broader heavy-metal chelation market.

A reliable standalone global revenue figure is not generally disclosed by manufacturers, distributors, or public companies. Product-level sales are usually immaterial within the reporting segments of diversified pharmaceutical companies.

What drives demand for edetate calcium disodium?

Demand is shaped by clinical events rather than prescription growth. The principal drivers are:

1. Severe pediatric or adult lead poisoning.
2. Occupational and environmental lead exposure.
3. Public-health investigations involving contaminated housing, soil, water, food, or consumer products.
4. Hospital preparedness and antidote stocking.
5. Poison-control recommendations.
6. Limited substitution options for severe lead poisoning.

The drug has a low-frequency, high-importance demand profile. Hospitals may need to stock the product even when annual utilization is minimal.

How does lead exposure affect the commercial market?

Lead exposure remains a public-health issue, especially in older housing and communities with industrial contamination. CDC guidance has lowered the blood lead reference value over time as evidence of harm at lower concentrations has accumulated.[2] That change increases testing and case identification but does not translate directly into equivalent growth in edetate calcium disodium sales. Many patients with elevated lead levels do not require injectable chelation.

The market is therefore more sensitive to the number of severe cases than to the total number of patients with detectable lead exposure.

How does edetate calcium disodium compare with competing chelation drugs?

Edetate calcium disodium competes within a narrow therapeutic category. The alternatives differ by route, indication, toxicity profile, and severity of poisoning.

Drug	Main role	Route	Commercial relationship
Edetate calcium disodium	Severe lead poisoning	IV or IM	Direct injectable competitor
Succimer	Mild to moderate lead poisoning in selected patients	Oral	Main practical substitute in less severe cases
Dimercaprol	Severe lead poisoning, often with encephalopathy, and selected metal poisonings	IM	Often used in combination with edetate calcium disodium
Penicillamine	Selected chronic metal poisonings	Oral	Limited alternative use
Disodium EDTA	Different chelation product and risk profile	IV	Not interchangeable with calcium disodium EDTA

Succimer can reduce demand for injectable edetate calcium disodium when patients qualify for oral therapy. Dimercaprol can increase demand for edetate calcium disodium in severe cases because the two drugs may be used together under specialist direction.[2]

The product does not face conventional biologic competition. Biosimilar development is irrelevant because edetate calcium disodium is a chemically synthesized small molecule.

What formulations are protected by edetate calcium disodium patents?

The commercially important formulation is an injectable aqueous solution, commonly supplied at 200 mg/mL in single-dose containers. There is no widely recognized current formulation patent strategy that materially protects the standard product.

Potential formulation barriers are operational rather than exclusivity-based. A manufacturer must demonstrate:

• Sterility assurance
• Container and closure compatibility
• Stability over the labeled shelf life
• Correct calcium-to-EDTA composition
• Control of elemental impurities
• Consistent concentration and pH
• Extractables and leachables compliance
• Reliable fill-finish capacity

These requirements can deter entry even when patents do not.

Who manufactures or supplies edetate calcium disodium?

Supply has historically involved generic injectable manufacturers and legacy branded product channels. Manufacturer participation can change because the market is small and the product may be discontinued, transferred, or supplied through a contract-manufacturing arrangement.

The relevant competitive set includes:

• Generic injectable manufacturers
• Hospital-distribution suppliers
• Contract manufacturers
• Government and public-health procurement channels
• Specialty pharmaceutical distributors

Hospitals typically purchase through group purchasing organizations, wholesalers, direct contracts, or shortage-allocation channels. A supplier with dependable inventory can obtain disproportionate commercial value despite low absolute market volume.

What is the financial trajectory for edetate calcium disodium?

The drug’s financial trajectory is best described as stable-to-volatile at the product level and immaterial at the diversified-company level.

Financial factor	Effect on revenue
Severe lead-poisoning incidence	Supports baseline demand
Low treatment frequency	Limits volume growth
Generic competition	Compresses ordinary pricing
Limited supplier base	Can support temporary price increases
Shortages	Create episodic revenue spikes and procurement premiums
Hospital stocking	Supports recurring baseline orders
Injectable manufacturing costs	Limits margin at low production volumes
No active exclusivity	Restricts sustained premium pricing
Public-health events	Can create short-term demand surges

A supplier may earn attractive margins during shortage periods, but those margins are difficult to sustain. Once multiple suppliers restore inventory, purchasing organizations and hospitals generally push pricing toward generic injectable norms.

Is edetate calcium disodium a material revenue product?

For a diversified pharmaceutical company, probably not. The drug is unlikely to be reported as a separate revenue line unless it is part of a narrowly focused hospital-products portfolio. Public financial disclosures usually group such products within broader categories such as generic injectables, hospital products, or specialty pharmaceuticals.

The principal financial value may lie in portfolio completeness, hospital-account access, and supply reliability rather than in standalone sales scale.

What generic entry risks exist for edetate calcium disodium?

Generic entry risk is structurally high because the molecule is old and patent protection is weak. That risk is moderated by the small market and manufacturing complexity.

Likely generic launch scenarios

Scenario	Market effect
New entrant enters during adequate supply	Lower prices and weaker incumbent share
New entrant enters during shortage	Rapid uptake and improved supply resilience
One incumbent exits	Higher shortage and allocation risk
Multiple manufacturers remain active	Stable pricing with limited margin expansion
FDA quality action affects a supplier	Temporary market disruption and price volatility

A new generic entrant may not pursue the product unless it can obtain dependable API supply, secure sterile manufacturing capacity, and achieve sufficient hospital distribution. Regulatory approval alone does not guarantee economic success.

What patent litigation and settlement agreements affect the market?

There is no well-known current patent litigation pattern comparable to major branded medicines. Paragraph IV litigation and settlement agreements are not central to the commercial outlook for edetate calcium disodium.

The more relevant legal and regulatory disputes would involve:

• Product liability
• Labeling and medication-error allegations
• Manufacturing quality
• Drug-shortage reporting
• Contracting and allocation
• Compounding or unauthorized distribution
• False or misleading claims for non-approved chelation uses

FDA-approved use should be distinguished from unapproved promotional claims. Calcium disodium EDTA has periodically been marketed or discussed for cardiovascular and atherosclerosis-related chelation uses, but those uses do not define the FDA-approved commercial market.[1]

How strong is the patent estate for edetate calcium disodium?

The patent estate is weak. Commercial defensibility depends on execution.

Patent-estate metric	Assessment
Composition-of-matter protection	Weak or expired
Method-of-use protection	Weak for approved lead indication
Formulation protection	Limited
Manufacturing know-how	Potentially meaningful
Regulatory barriers	Moderate for sterile injectable approval
Supply-chain barriers	Moderate to high
Brand loyalty	Low
Hospital switching costs	Moderate during shortages, low during adequate supply

The strongest assets are likely to be manufacturing know-how, validated sterile capacity, supply reliability, distribution relationships, and inclusion in hospital formularies.

What is the outlook for edetate calcium disodium?

The outlook is a mature essential-medicine niche with low structural growth and recurring supply volatility. Demand should remain resilient because severe lead poisoning will continue to require chelation and hospitals must maintain access to approved therapy.

Revenue growth is unlikely to come from broad patient expansion. Upside depends on:

• Shortage conditions
• Government procurement
• New hospital contracts
• Improved distribution
• Price increases during constrained supply
• Portfolio bundling with other antidotes and hospital injectables

Downside risks include supplier withdrawal, FDA quality actions, generic price erosion, substitution with succimer in eligible patients, and low utilization relative to the cost of maintaining sterile production.

Key Takeaways

• Edetate calcium disodium is an FDA-approved injectable treatment for severe lead poisoning.
• It is a mature generic product with no meaningful current core patent protection.
• Orange Book and Paragraph IV issues are secondary to sterile manufacturing and supply reliability.
• The drug has no biosimilar risk because it is a small-molecule chelator.
• Standalone revenue is not generally disclosed and is likely immaterial within diversified pharmaceutical companies.
• The commercial market is small, clinically important, and vulnerable to shortages.
• Pricing can rise sharply during supply interruptions but is difficult to sustain after supply normalizes.
• Succimer and dimercaprol are the most relevant clinical alternatives, although they are not fully interchangeable.
• The strongest competitive advantages are validated injectable capacity, API access, hospital distribution, and dependable inventory.
• Long-term growth is limited; financial performance will remain driven by supply events and procurement conditions.

FAQs About Edetate Calcium Disodium Market and Exclusivity

Is edetate calcium disodium still commercially available?

It remains an established hospital injectable, but availability can vary by manufacturer, wholesaler inventory, and FDA shortage conditions.

Can a pharmaceutical company obtain new exclusivity for edetate calcium disodium?

A company could pursue regulatory exclusivity only through a qualifying new approval or legally available designation. The basic old drug does not retain original new-chemical-entity exclusivity.

Is calcium disodium EDTA the same as disodium EDTA?

No. They have different calcium content, clinical uses, and safety risks. Medication errors between the products can cause serious harm.[1]

Does edetate calcium disodium treat cardiovascular disease?

Its FDA-approved indication is lead poisoning. Use for other conditions requires separate clinical and regulatory analysis and is not the basis of the approved product market.

What would make edetate calcium disodium financially attractive to a manufacturer?

The strongest commercial case would involve reliable sterile capacity, shortage-resilient supply, hospital distribution, and a broader portfolio of antidotes or generic injectables. Standalone volume is unlikely to justify a large dedicated commercial infrastructure.

References

1. U.S. Food and Drug Administration. (n.d.). Edetate calcium disodium injection prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

2. Centers for Disease Control and Prevention. (n.d.). Recommended actions based on blood lead level. https://www.cdc.gov/lead-prevention/

3. U.S. Food and Drug Administration. (n.d.). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book