DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM Drug Patent Profile

Which patents cover Diatrizoate Meglumine And Diatrizoate Sodium, and when can generic versions of Diatrizoate Meglumine And Diatrizoate Sodium launch?

Diatrizoate Meglumine And Diatrizoate Sodium is a drug marketed by Adaptis and Annora Pharma and is included in two NDAs.

The generic ingredient in DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM is diatrizoate meglumine; diatrizoate sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diatrizoate Meglumine And Diatrizoate Sodium

A generic version of DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM was approved as diatrizoate meglumine; diatrizoate sodium by ADAPTIS on June 27^th, 2022.

Summary for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	407
DailyMed Link:	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM at DailyMed

Pharmacology for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

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

US Patents and Regulatory Information for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adaptis	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	214201-001	Jun 27, 2022	AA	RX	No	No
Annora Pharma	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	215049-001	Nov 17, 2023	AA	RX	No	No

Diatrizoate Meglumine and Diatrizoate Sodium Market Dynamics, Patent Status, and Financial Trajectory

Last updated: October 28, 2026

Diatrizoate meglumine and diatrizoate sodium are mature, low-cost, water-soluble iodinated contrast media used mainly for gastrointestinal imaging, selected radiographic procedures, and limited nonvascular applications. The products have no meaningful remaining composition-of-matter exclusivity, limited patent protection, and a fragmented generic supply base. Their commercial outlook is stable to declining in high-income markets, with revenue driven by hospital procedure volumes, supply reliability, and manufacturing economics rather than innovation.

The principal marketed combination is the oral and rectal contrast formulation sold under brands including Gastrografin and MD-Gastroview. Diatrizoate products face long-term substitution from nonionic low-osmolar contrast agents, fluoroscopy alternatives, CT protocols that use different agents, and noncontrast imaging.

What are diatrizoate meglumine and diatrizoate sodium used for?

Diatrizoate meglumine and diatrizoate sodium are ionic, water-soluble iodinated contrast agents. The meglumine salt and sodium salt provide the iodinated diatrizoate anion in formulations designed for oral, rectal, or injectable administration.

The principal clinical uses are:

• Contrast enhancement of the gastrointestinal tract during radiographic examinations.
• Computed tomography of the abdomen and pelvis when enteric contrast is required.
• Evaluation of suspected gastrointestinal perforation or obstruction.
• Selected arthrographic, urologic, or angiographic procedures, depending on the formulation and label.
• Use in patients for whom barium is unsuitable, including cases involving suspected perforation.

Gastrografin is an oral or rectal solution containing diatrizoate meglumine and diatrizoate sodium. MD-Gastroview is a comparable enteric contrast product. FDA labeling emphasizes that these products are hyperosmolar and can cause fluid shifts, aspiration-related pulmonary complications, dehydration, and electrolyte abnormalities in vulnerable patients (U.S. Food and Drug Administration [FDA], 2023a; FDA, 2023b).

Which products contain diatrizoate meglumine and diatrizoate sodium?

Product or product category	Active ingredients	Main route	Primary use	Commercial position
Gastrografin	Diatrizoate meglumine and diatrizoate sodium	Oral or rectal	GI tract imaging and CT enteric contrast	Branded mature product
MD-Gastroview	Diatrizoate meglumine and diatrizoate sodium	Oral or rectal	GI tract imaging and CT enteric contrast	Branded mature product
Generic diatrizoate solutions	Diatrizoate meglumine, diatrizoate sodium, or both	Oral, rectal, or injectable	Radiographic contrast	Price-driven generic supply
Legacy injectable products	Diatrizoate meglumine or diatrizoate sodium	Intravenous or intra-arterial	Historical vascular and urinary imaging	Largely displaced in many indications

Product availability varies by jurisdiction, concentration, container size, and route. Oral and rectal combination products are commercially more relevant than older ionic injectable products in many U.S. hospital settings.

What is the FDA regulatory status of diatrizoate products?

Diatrizoate products are FDA-approved prescription drugs and diagnostic agents. Gastrografin and MD-Gastroview have labeling for oral or rectal administration. The products are not biologics and do not create biosimilar exposure.

FDA regulatory issues are primarily operational:

• Product-specific labeling governs route, concentration, dilution, and indication.
• Generic approvals may be submitted through abbreviated new drug applications where the dosage form, route, labeling, and performance requirements are satisfied.
• Manufacturing changes require compliance with drug quality, sterility, packaging, and stability requirements.
• Injectable products face tighter manufacturing controls than oral or rectal solutions.
• Supply disruptions can result from limited manufacturing capacity, component shortages, or site-specific quality events.

The products have no active FDA exclusivity period of commercial significance. Their regulatory value comes from approved labeling and manufacturing authorization, not from market exclusivity.

What is the Orange Book status of diatrizoate meglumine and diatrizoate sodium?

Diatrizoate products do not have a commercially meaningful Orange Book patent barrier. The active ingredients are old ionic contrast media, and any original composition-of-matter patents expired many years ago.

For a mature product such as Gastrografin or MD-Gastroview, the relevant Orange Book analysis is:

Orange Book issue	Assessment
New chemical entity exclusivity	Expired
Five-year NCE exclusivity	Not relevant to current competition
Pediatric exclusivity	No material current impact
Active ingredient patents	None expected to block generic entry
Formulation patents	No known commercially significant barrier
Method-of-use patents	No material barrier to standard labeled uses
Paragraph IV exposure	Low strategic significance
Authorized generic risk	Possible, but usually less important than ordinary generic competition

Orange Book listings can change with NDA maintenance, product discontinuation, and FDA database updates. The commercial conclusion remains unchanged: generic entry is not constrained by an unexpired patent estate.

What patents protect diatrizoate meglumine and diatrizoate sodium?

The principal patent protection has expired. Diatrizoic acid and its salts were developed decades ago, well before the current pharmaceutical patent landscape. The core active ingredient, salt chemistry, and traditional radiographic uses are in the public domain.

Formulation patents

Modern formulation protection is limited because the products use established salts in aqueous solutions. Potentially protectable features could include:

• Concentration ranges.
• Container systems.
• Dilution protocols.
• Stability characteristics.
• Packaging configurations.
• Specific combinations with other diagnostic agents.

These features generally have limited exclusionary value when the underlying drug and clinical use are old. A formulation patent would need to claim a commercially important difference that competitors cannot design around easily. No widely recognized patent estate currently prevents competitors from marketing comparable diatrizoate products.

Method-of-use patents

Method-of-use protection is also weak. The principal uses, including GI visualization and CT-related enteric contrast, are established clinical applications. A narrow patent could theoretically cover a specific administration protocol or diagnostic workflow, but such a patent would not normally prevent generic products from competing in the broader market.

Manufacturing and process protection

Manufacturing know-how may still matter commercially. Relevant barriers include:

• Consistent production of high-concentration solutions.
• Control of impurities and degradation products.
• Sterile manufacturing for injectable presentations.
• Container-closure compatibility.
• Large-scale quality testing.
• Reliable access to iodinated chemical intermediates.

These are trade-secret and operational barriers rather than enforceable market exclusivities.

When does diatrizoate lose exclusivity?

Diatrizoate lost meaningful exclusivity decades ago. The active ingredients and traditional uses are generic-market technologies. There is no current patent expiration date that determines U.S. generic entry.

The commercial exclusivity timeline is best understood as follows:

Period	Market event
Historical development period	Diatrizoate salts introduced as ionic iodinated contrast agents
Original approval period	Branded and institutional contrast products established
Patent-expiration period	Core composition and early use patents expired
Generic competition period	Multiple suppliers entered or became capable of supplying comparable products
Current market	Mature, low-growth diagnostic product with supply and price competition

Any current exclusivity would have to arise from a newly approved formulation, orphan designation, pediatric extension, or later patent. Those mechanisms do not materially define the existing diatrizoate market.

Which companies manufacture or market diatrizoate products?

The most relevant commercial participants include:

• Bracco Diagnostics, associated with Gastrografin in the U.S. market.
• Mallinckrodt and related diagnostic-product operations, associated with MD-Gastroview.
• Generic and contract manufacturers supplying diatrizoate solutions to hospitals, distributors, and imaging providers.
• International contrast-media companies marketing diatrizoate under local brand names, including historical Urografin-related products.

The supplier base is narrower than the underlying chemistry would suggest. Contrast media require validated production, specialized quality systems, regulatory approvals, and hospital procurement relationships. This can produce temporary pricing power even when no patent protection exists.

How does the diatrizoate market compare with modern contrast agents?

Attribute	Diatrizoate meglumine/sodium	Nonionic low-osmolar agents
Chemical class	Ionic, high-osmolar iodinated contrast	Nonionic, generally lower-osmolar iodinated contrast
Primary use	GI and selected legacy radiographic applications	CT, angiography, vascular imaging, and broad hospital use
Tolerability	More hyperosmolarity-related risk	Generally better tolerated systemically
Patent status	Mature and largely unprotected	Some products have had later patent and formulation protection
Price	Low to moderate	Higher, depending on agent and procurement
Growth profile	Flat or declining	Larger addressable market
Main competitive factor	Availability and price	Clinical performance, safety, supply, and contracts

Diatrizoate remains useful where a high-density water-soluble enteric agent is required. It is less competitive for routine intravascular imaging, where modern nonionic agents dominate because of safety and tolerability considerations.

What is the financial trajectory for diatrizoate meglumine and diatrizoate sodium?

No major manufacturer generally reports standalone global revenue for diatrizoate meglumine and diatrizoate sodium. The products are typically grouped within broader diagnostic imaging, contrast media, or pharmaceutical portfolios. A precise product-level revenue figure therefore cannot be derived from public company reporting.

The financial trajectory is nevertheless clear:

1. Revenue is mature rather than growth-driven.
2. Unit demand is linked to GI imaging volumes and hospital utilization.
3. Average selling prices are constrained by generic competition and procurement tenders.
4. Branded products can retain pricing premiums where hospitals value continuity of supply.
5. Margin performance depends heavily on manufacturing scale and raw-material costs.
6. Temporary shortages can raise prices but may also accelerate substitution.
7. Long-term share loss is likely in applications where clinicians can use newer or nonionic agents.

Revenue exposure by demand driver

Revenue driver	Directional effect
Growth in CT and radiology procedures	Supports demand
Decline in conventional fluoroscopy	Reduces demand
Continued use in suspected GI perforation	Supports niche demand
Nonionic contrast substitution	Negative
Hospital generic purchasing	Negative for price
Supply interruptions	Can increase short-term pricing but reduce trust
International tender markets	Compress margins
Product withdrawals	Can shift share to remaining suppliers

The product category is more defensive than innovative. Cash generation can remain attractive for an efficient manufacturer with validated capacity, but the market does not offer the growth profile of newer contrast agents, radiopharmaceuticals, or imaging technologies.

What supply-chain risks affect diatrizoate products?

The main commercial risks are manufacturing and distribution risks rather than patent litigation.

Chemical and manufacturing risks

Diatrizoate production requires iodinated aromatic intermediates, salt formation, purification, concentration control, and validated packaging. Injectable products add sterility and particulate-control requirements.

Risk points include:

• Dependence on a limited number of active pharmaceutical ingredient suppliers.
• Concentrated global production.
• Quality failures at a single manufacturing site.
• Packaging shortages for high-volume hospital products.
• Transportation constraints involving heavy liquid products.
• Low product margins that discourage redundant capacity.

Hospital procurement risks

Hospitals often purchase contrast media through group purchasing organizations, distributor contracts, and formulary arrangements. A product that lacks patent protection can still retain business if it has:

• Reliable fill rates.
• Established pharmacy and radiology workflows.
• Familiar labeling and dilution instructions.
• Compatible packaging.
• Stable wholesale pricing.
• A strong shortage-management record.

What generic entry risks exist?

Generic entry risk is structurally high because the active ingredients are old and the main uses are established. The main limitation is not legal entry but commercial attractiveness.

A new entrant would face:

• Modest market size relative to regulatory and manufacturing costs.
• Low selling prices.
• Existing supplier relationships.
• Potentially volatile demand by presentation.
• Quality-control requirements for concentrated solutions.
• Procurement pressure from hospitals and distributors.

The most realistic generic launch scenario is not a large wave of new entrants. It is selective participation by manufacturers that already produce iodinated contrast media or have established hospital distribution.

Which companies are challenging the diatrizoate market?

Competition is more likely to occur through substitution than through Paragraph IV litigation. Generic manufacturers can compete with approved diatrizoate products, while larger imaging companies compete for the broader contrast-media budget with nonionic agents.

The competitive set includes:

• Bracco.
• Mallinckrodt-related diagnostic operations.
• Generic contrast manufacturers.
• Bayer, GE HealthCare, and Guerbet in adjacent iodinated contrast markets.
• Hospital and regional suppliers offering lower-cost alternatives.

The competitive threat from Bayer, GE HealthCare, and Guerbet is indirect. Their major products are not necessarily direct substitutes for oral or rectal diatrizoate, but they compete for radiology department budgets and can displace ionic agents in broader imaging protocols.

What patent litigation and settlement agreements affect diatrizoate?

No major active Paragraph IV litigation or settlement framework is known to define the diatrizoate meglumine and diatrizoate sodium market. The products are too mature for patent litigation to be the principal competitive mechanism.

Litigation risk is more likely to involve:

• Product liability claims.
• Contrast-reaction allegations.
• Labeling and warning issues.
• Manufacturing defects.
• Supply-contract disputes.
• Regulatory compliance.

There is no apparent commercial reason for a branded diatrizoate sponsor to negotiate a delayed generic-entry settlement based on a strong unexpired patent.

How strong is the diatrizoate patent estate?

The patent estate is weak as an exclusionary asset but durable as a manufacturing platform.

Patent-estate factor	Assessment
Core molecule	Public-domain technology
Salt chemistry	Mature
Standard indications	Long-established
Formulation differentiation	Limited
Delivery-system protection	Limited for oral and rectal solutions
Manufacturing know-how	Potentially valuable
Patent litigation leverage	Low
Generic vulnerability	High
Commercial durability	Dependent on supply and procurement

For investors and licensing teams, the value is in approved manufacturing, distribution, and customer access. Patent licensing has limited strategic value unless tied to a newer delivery system, combination product, or diagnostic workflow.

What are the likely generic launch scenarios?

Base case

Existing suppliers continue serving a stable niche. Prices remain under pressure, and volumes decline gradually as imaging practice shifts toward nonionic agents and alternative protocols.

Upside case

A competitor exits, a manufacturing interruption occurs, or a shortage increases the value of available supply. Remaining suppliers gain temporary volume and pricing leverage.

Downside case

Additional suppliers enter, hospitals intensify tendering, or clinical substitution accelerates. Revenue and margins decline faster than procedure volumes.

Strategic launch case

A manufacturer introduces a differentiated package, ready-to-use presentation, or integrated imaging workflow. The product may gain share through convenience, but it would still face limited patent protection and aggressive hospital pricing.

What is the geographic outlook?

The United States and Western Europe are mature markets with strong generic pressure and extensive substitution by nonionic contrast agents. Demand is more resilient in countries where cost constraints preserve older ionic agents or where GI radiographic procedures remain common.

Emerging markets may offer volume growth, but pricing is often low and local registration, tender access, and distribution capability determine commercial success. Geographic expansion requires local approvals and reliable supply rather than new intellectual property.

Key Takeaways

• Diatrizoate meglumine and diatrizoate sodium are mature ionic iodinated contrast agents used mainly for oral and rectal GI imaging.
• Gastrografin and MD-Gastroview are the principal recognized combination products in the U.S. market.
• Core patent protection and regulatory exclusivity expired decades ago.
• No meaningful active Orange Book patent barrier or Paragraph IV litigation is expected to control generic entry.
• The market is driven by hospital procedure volumes, supply reliability, procurement contracts, and manufacturing economics.
• Revenue is generally stable to declining, with no reliable standalone public revenue disclosure for the active ingredients.
• Nonionic low-osmolar contrast agents are the principal long-term competitive threat in broader radiology.
• Manufacturing capacity, quality compliance, and distribution are more valuable than patent rights.
• The strongest commercial opportunity arises during supply disruptions or supplier exits, not from sustained market expansion.

FAQs

Is diatrizoate meglumine the same as Gastrografin?

No. Gastrografin is a branded formulation containing diatrizoate meglumine and diatrizoate sodium. The active ingredients are the salts; Gastrografin is the marketed product and formulation.

Can diatrizoate be replaced by barium contrast?

Sometimes. Water-soluble diatrizoate is often selected when perforation is suspected because barium leakage can create serious complications. The clinical choice depends on the procedure, suspected pathology, and radiologist’s protocol.

Is diatrizoate a generic drug?

Diatrizoate is a generic active ingredient, but products may be sold under branded or generic labels. Regulatory approval applies to the specific formulation, manufacturer, route, concentration, and packaging.

Why does diatrizoate remain available despite weak patent protection?

Hospitals still require water-soluble enteric contrast for selected diagnostic procedures. Continued availability depends on established clinical use, low manufacturing cost, and supplier relationships rather than exclusivity.

Does diatrizoate have biosimilar competition?

No. Diatrizoate is a small-molecule chemical drug, not a biologic. It is subject to ordinary generic competition rather than the FDA biosimilar pathway.

References

1. U.S. Food and Drug Administration. (2023a). Gastrografin (diatrizoate meglumine and diatrizoate sodium) oral or rectal solution: Prescribing information.
2. U.S. Food and Drug Administration. (2023b). MD-Gastroview (diatrizoate meglumine and diatrizoate sodium) oral or rectal solution: Prescribing information.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
4. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database.
5. American College of Radiology. (2024). ACR manual on contrast media. American College of Radiology.
6. Bracco Diagnostics Inc. (2023). Gastrografin product information.
7. Mallinckrodt Pharmaceuticals. (2023). MD-Gastroview product information.