E-Z-HD Drug Patent Profile

When do E-z-hd patents expire, and what generic alternatives are available?

E-z-hd is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in E-Z-HD is barium sulfate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the barium sulfate profile page.

Summary for E-Z-HD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Patent Applications:	3,450
What excipients (inactive ingredients) are in E-Z-HD?	E-Z-HD excipients list
DailyMed Link:	E-Z-HD at DailyMed

Pharmacology for E-Z-HD

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for E-Z-HD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	E-Z-HD	barium sulfate	FOR SUSPENSION;ORAL	208036-001	Jan 11, 2016		RX	Yes	Yes

E-Z-HD Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 8, 2026

E-Z-HD is a mature, nonradioactive oral barium sulfate contrast agent marketed in the United States by Bracco Diagnostics Inc. The product is used primarily for radiographic and computed tomography examinations of the gastrointestinal tract. Its commercial outlook is tied to procedure volumes, hospital purchasing, radiology utilization, and supply reliability rather than to conventional prescription-drug demand.

Public sources do not disclose E-Z-HD’s product-level sales, profit, market share, or standalone forecast. Bracco Diagnostics is part of privately held Bracco Imaging, which does not report revenue by individual contrast product. The available evidence supports a mature-product assessment: limited patent-driven exclusivity, established clinical use, recurring institutional demand, and competitive pressure from other barium formulations and alternative imaging protocols.

What is E-Z-HD and how is it used?

E-Z-HD is a high-density barium sulfate powder for oral suspension. Barium sulfate is an insoluble radiopaque compound that coats the gastrointestinal tract and improves visualization during X-ray and CT examinations. E-Z-HD is not absorbed systemically and is used as a diagnostic aid rather than as a therapeutic drug.

The product is used in procedures involving:

• The esophagus and upper gastrointestinal tract
• The stomach and duodenum
• Abdominal CT examinations requiring enteric contrast
• Evaluation of gastrointestinal structure, obstruction, perforation risk, and other abnormalities

The FDA-approved label identifies E-Z-HD as a prescription diagnostic product and states that it is supplied as a 98% weight/weight barium sulfate formulation for suspension.[1]

Product profile

Attribute	E-Z-HD
Active ingredient	Barium sulfate
Dosage form	Powder for oral suspension
Concentration	98% weight/weight
Therapeutic category	Radiographic contrast agent
Route	Oral
Primary users	Hospitals, imaging centers, radiology departments
Manufacturer	Bracco Diagnostics Inc.
Product type	Mature diagnostic pharmaceutical
Biosimilar relevance	None
Principal commercial driver	Gastrointestinal imaging volume

E-Z-HD competes in a category where product selection is influenced by radiologist preference, imaging protocol, preparation time, patient tolerability, procurement contracts, and product availability.

What is the FDA regulatory status of E-Z-HD?

E-Z-HD is an FDA-approved barium sulfate diagnostic product. The FDA label identifies 2004 as the initial U.S. approval year.[1] It is regulated as a drug product rather than as a biologic or medical device.

The product’s regulatory value is based on an established active ingredient and a defined formulation. Barium sulfate has a long history of clinical use, which reduces clinical adoption risk but also limits differentiation. The principal regulatory barriers for competing products are product quality, manufacturing controls, labeling, stability, packaging, and evidence supporting the proposed use and formulation.

Does E-Z-HD have biosimilar competition?

No. Biosimilar rules apply to biological products, and E-Z-HD is a chemically defined barium sulfate drug. Potential competitors would enter through generic or alternative drug-product pathways, not through the abbreviated biosimilar pathway.

What patents protect E-Z-HD?

E-Z-HD does not appear to have a commercially important patent moat comparable to newer branded pharmaceuticals. The active ingredient, barium sulfate, is an old inorganic compound. Any historical formulation or process patents associated with high-density suspensions would likely have limited remaining term or would have expired, given the product’s 2004 approval date and the long history of barium contrast products.

The practical protection profile is therefore based on:

• FDA approval and labeling
• Manufacturing know-how
• Product consistency and radiopacity
• Hospital formulary position
• Distribution relationships
• Brand recognition among radiology departments
• Contracting and supply reliability

What is the Orange Book status of E-Z-HD?

A definitive current Orange Book patent-and-exclusivity determination requires review of the FDA’s current product and patent files. Publicly available product information does not establish a meaningful active patent barrier for E-Z-HD. The product’s commercial position should therefore be analyzed as a mature branded diagnostic product rather than as a patent-protected growth asset.

The most relevant risk is not loss of a near-term patent expiry. It is substitution by another FDA-approved barium product, procurement switching, or reduced utilization of oral contrast in selected imaging protocols.

When does E-Z-HD lose exclusivity?

E-Z-HD’s principal regulatory exclusivity period is historical rather than current. The product was approved in 2004, and any standard new-drug exclusivity associated with the original approval would have expired years ago. There is no apparent current market exclusivity period that would prevent competing barium sulfate products from entering solely because of E-Z-HD’s original approval.

The absence of active regulatory exclusivity changes the commercial analysis:

Exclusivity factor	Current assessment
Original approval exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No publicly identified active period
Biosimilar exclusivity	Not applicable
Patent cliff	No clearly identified near-term cliff
Generic-entry exposure	Structurally high
Brand defense	Manufacturing, contracts, reputation, and supply

How many patents cover E-Z-HD?

No reliable public basis supports assigning a precise number of active, commercially relevant patents to E-Z-HD. The product should not be valued on the assumption that a large active patent estate protects it.

Patent analysis for this type of product should distinguish between:

1. Patents covering barium sulfate itself, which are generally not commercially relevant because of the compound’s age.
2. Historical formulation patents, many of which are likely expired.
3. Manufacturing or suspension-quality claims, which may be difficult to identify as product-specific barriers.
4. Packaging, device, or administration claims, which may have limited scope.
5. Patents covering other Bracco products rather than E-Z-HD.

For investment or litigation purposes, the absence of a clearly identified active patent estate means that freedom-to-operate analysis should focus on competitor formulations, manufacturing processes, trademarks, and FDA approval strategy.

What formulations compete with E-Z-HD?

E-Z-HD competes with multiple barium sulfate products that differ in concentration, viscosity, flavoring, particle characteristics, preparation requirements, and intended imaging use.

Adjacent Bracco products

Bracco’s barium sulfate portfolio includes products associated with gastrointestinal and CT imaging, including E-Z-PAQUE, E-Z-CAT, Readi-CAT, and other branded formulations. These products are not direct substitutes in every procedure. Product choice depends on whether the imaging protocol requires a high-density suspension, a ready-to-use liquid, a flavored preparation, or a lower-viscosity formulation.

External competition

The competitive set can include:

• Other branded barium sulfate products
• Generic barium sulfate powders and suspensions
• Hospital-compounded or protocol-specific preparations, where permitted
• Water-soluble iodinated contrast in selected gastrointestinal settings
• Imaging protocols that use no oral contrast
• MRI or ultrasound alternatives for specific clinical questions

Barium products retain an important role because they are inexpensive relative to many iodinated or gadolinium-based agents and provide effective mucosal coating. Their limitations include aspiration risk, constipation, obstruction concerns, and contraindications where perforation is suspected.

What market forces affect E-Z-HD demand?

E-Z-HD demand follows the volume and type of gastrointestinal imaging rather than a traditional pharmaceutical treatment market.

Procedure volume

Higher CT and radiographic procedure volumes support demand. Aging populations, cancer surveillance, emergency imaging, and chronic gastrointestinal disease can support utilization. The offset is protocol change. Some institutions reduce or eliminate oral contrast for selected CT examinations because of workflow preferences, limited diagnostic benefit in certain indications, or patient throughput requirements.

Hospital procurement

Hospitals often buy diagnostic contrast through group purchasing organizations, regional contracts, or enterprise purchasing arrangements. Price, delivery reliability, preparation burden, waste, and compatibility with local protocols can outweigh small differences in clinical performance.

Supply reliability

Barium sulfate products are sensitive to manufacturing and distribution interruptions. A shortage can temporarily shift demand among products, but those gains may not persist after supply normalizes. For a mature product, consistent availability can be a more important commercial asset than incremental formulation innovation.

Radiology workflow

High-density products can be selected when radiopacity and gastrointestinal coating are priorities. Ready-to-use products may gain preference where staff time and preparation simplicity are important. Powder products can remain attractive when storage, shipping, or cost advantages offset preparation requirements.

Which companies challenge Bracco in the barium contrast market?

Bracco faces competition from other manufacturers of barium sulfate products and from broader diagnostic imaging alternatives. The relevant competitive landscape is fragmented by dosage form and clinical use rather than dominated by a single direct substitute.

Competitive pressure comes from:

• Generic drug manufacturers
• Established contrast-media companies
• Specialty radiology-product suppliers
• Hospitals seeking lower-cost equivalents
• Protocol changes that reduce the use of oral contrast

The strongest competitive threat is likely formulary substitution, not a high-profile Paragraph IV litigation campaign. There is no widely reported current Paragraph IV dispute that defines E-Z-HD’s market position.

What patent litigation or settlement agreements affect E-Z-HD?

No prominent publicly reported patent litigation or settlement agreement appears to be central to E-Z-HD’s current commercial outlook. That is consistent with the product’s age, the commodity-like nature of barium sulfate, and the lack of a visible active patent cliff.

The principal legal issues are more likely to involve:

• Product liability
• Labeling and contraindication compliance
• Manufacturing quality
• Supply agreements
• Trademark enforcement
• Procurement disputes
• Regulatory compliance

A competitor entering with a similar barium formulation would face FDA and manufacturing requirements but would not necessarily face a significant patent barrier from the E-Z-HD brand.

What is E-Z-HD’s financial trajectory?

E-Z-HD’s product-level financial trajectory is not publicly reported. Bracco Imaging does not provide a public revenue line for E-Z-HD, and Bracco Diagnostics is not a separately traded company with detailed product disclosures.

The likely trajectory is that of a mature, recurring diagnostic product:

Financial driver	Expected effect
Stable imaging volumes	Supports recurring demand
Pricing pressure	Limits revenue growth
Generic substitution	Creates unit and margin risk
Protocol changes	Can reduce utilization
Supply disruptions	Can create temporary volatility
Bracco distribution	Supports retention
Product age	Limits premium pricing
Portfolio bundling	May protect account relationships

Revenue is likely generated through institutional purchases rather than direct patient prescriptions. That structure makes sales dependent on tenders, contracts, distributor margins, and procedure volume. A product can maintain meaningful cash generation without delivering high growth, particularly when manufacturing costs are controlled and the brand is embedded in hospital protocols.

Revenue exposure assessment

A reasonable commercial classification is:

• Growth potential: Low
• Cash-flow durability: Moderate
• Patent protection: Low
• Generic-entry risk: High
• Regulatory risk: Low to moderate
• Supply-chain risk: Moderate
• Pricing power: Low to moderate
• Strategic value: Portfolio and account-retention asset

How does E-Z-HD compare with newer contrast agents?

E-Z-HD has a lower unit-cost profile and a long clinical history, but it lacks the patent protection and pricing power associated with newer contrast agents.

Attribute	E-Z-HD	Newer patented contrast agent
Active ingredient age	Very old	Often newer
Patent protection	Limited or expired	Frequently significant
Clinical differentiation	Formulation and density	May include mechanism or delivery innovation
Procurement basis	Price, availability, workflow	Clinical value and protocol preference
Generic risk	High	Depends on patent estate
Revenue growth	Procedure-linked	May be indication- or launch-driven
Margin profile	Mature-product economics	Potentially higher during exclusivity

E-Z-HD is better viewed as a stable infrastructure product in diagnostic imaging than as a pipeline-style pharmaceutical asset.

What generic launch scenarios exist for E-Z-HD?

Three scenarios are commercially relevant.

Limited substitution

Bracco retains share because of product familiarity, supply reliability, established contracts, and physician preference. Price erosion remains gradual.

Accelerated generic substitution

A competing product wins hospital contracts through lower price, ready availability, or a simpler preparation profile. Bracco may respond through discounts, bundled contracting, or portfolio migration.

Protocol-driven volume decline

Use decreases because hospitals revise CT protocols or shift selected examinations away from oral barium. This scenario reduces the total market and makes share gains less valuable.

The most likely outcome is gradual price and volume pressure rather than a single abrupt patent-driven revenue collapse.

What is the geographic coverage of E-Z-HD?

E-Z-HD is principally associated with the U.S. Bracco Diagnostics market. Bracco Imaging has international operations, but regulatory approvals, brand names, packaging, and distribution arrangements vary by country. The commercial value of E-Z-HD outside the United States cannot be inferred from the U.S. label alone.

Geographic expansion is constrained by:

• Country-specific drug registrations
• Local contrast-agent procurement
• Reimbursement systems
• Hospital tendering
• Manufacturing-site approvals
• Translation and labeling requirements

Key Takeaways

• E-Z-HD is a mature oral barium sulfate diagnostic product marketed by Bracco Diagnostics.
• Its demand is linked to gastrointestinal radiography and CT procedure volumes.
• The product’s original approval exclusivity is historical and has expired.
• No significant active patent moat or current patent litigation is publicly evident.
• Biosimilar risk does not apply; generic and alternative-formulation risk does.
• Revenue, profit, and market share are not disclosed at the E-Z-HD product level.
• Financial performance is likely stable but exposed to price competition, protocol changes, and hospital procurement pressure.
• Manufacturing quality, supply reliability, and Bracco’s distribution relationships are more important than patent exclusivity.
• E-Z-HD is best valued as a mature recurring-revenue diagnostic product, not as a growth pharmaceutical asset.

Frequently Asked Questions

Is E-Z-HD a therapeutic drug?

No. E-Z-HD is a diagnostic contrast agent containing barium sulfate. It is used to improve visualization of the gastrointestinal tract during X-ray and CT procedures.

Is E-Z-HD the same as E-Z-PAQUE?

No. Both are Bracco barium sulfate products, but they are distinct formulations with different concentrations, physical properties, and protocol applications.

Can a generic company copy E-Z-HD?

A competitor cannot copy Bracco’s trade dress or proprietary manufacturing information, but it may pursue FDA approval for a comparable barium sulfate formulation if it satisfies applicable regulatory and quality requirements.

Does E-Z-HD have biosimilar competition?

No. Barium sulfate is a chemically defined drug, so potential competitors would use generic or other drug-approval pathways rather than the biosimilar pathway.

What is the main investment risk for E-Z-HD?

The main risk is gradual erosion from generic or alternative barium products, lower use of oral contrast in selected imaging protocols, hospital price negotiations, and supply-chain disruption.

References

1. U.S. Food and Drug Administration. (2004). E-Z-HD (barium sulfate) for suspension, 98% w/w: Prescribing information. Bracco Diagnostics Inc. https://www.accessdata.fda.gov
2. National Library of Medicine. (n.d.). DailyMed: E-Z-HD barium sulfate for suspension. https://dailymed.nlm.nih.gov
3. Bracco Imaging. (n.d.). Diagnostic imaging products and solutions. https://www.bracco.com
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files