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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CYSTOGRAFIN	diatrizoate meglumine	SOLUTION;URETHRAL	010040-018	Approved Prior to Jan 1, 1982		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bracco	CYSTOGRAFIN DILUTE	diatrizoate meglumine	SOLUTION;URETHRAL	010040-022	Nov 9, 1982		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 2, 2026

Cystografin is a mature, niche radiographic contrast agent used primarily for retrograde cystography and voiding cystourethrography. Its commercial outlook is defined by low unit volume, limited clinical substitution within selected procedures, generic and supply-chain pressure, and the absence of publicly disclosed product-level revenue. The product has no biosimilar exposure because it is a small-molecule contrast medium, while patent-based exclusivity is unlikely to be the main commercial barrier at this stage.

Cystografin Market Dynamics, Financial Trajectory, Patent Estate, and Competitive Outlook

What is Cystografin and how is it used?

Cystografin is an iodinated contrast medium containing diatrizoate salts. It is administered intravesically for radiographic examination of the urinary bladder and lower urinary tract.

The product is marketed in two principal concentrations:

Product	Active contrast composition	Primary use
Cystografin	Diatrizoate meglumine, approximately 30%	Retrograde cystography and voiding cystourethrography
Cystografin Dilute	Diatrizoate meglumine, approximately 18%	Lower-concentration bladder imaging procedures

The U.S. prescribing information identifies retrograde cystography and voiding cystourethrography as the principal indications. The drug is instilled into the bladder through a catheter rather than injected intravenously. That administration route limits systemic exposure but creates dependence on urology, radiology and hospital procedure volumes. (U.S. Food and Drug Administration, 2023a)

Cystografin is used in settings that include:

Evaluation of bladder injury or rupture
Assessment of vesicoureteral reflux
Pediatric voiding cystourethrography
Postoperative urinary-tract imaging
Investigation of structural abnormalities in the lower urinary tract

Clinical use is concentrated in hospitals, outpatient imaging departments and pediatric urology centers. Demand is procedural rather than chronic. A patient generally receives the product during a single diagnostic examination, so recurring revenue depends on procedure volume rather than prescription refills.

What is the current FDA regulatory status of Cystografin?

Cystografin is an FDA-approved prescription contrast agent. Its regulatory position is that of an established conventional drug product, not a biologic or advanced therapy.

FDA regulatory characteristics

Regulatory issue	Cystografin status
FDA product category	Iodinated radiographic contrast agent
Administration	Intravesical
Main labeled procedures	Retrograde cystography and voiding cystourethrography
Prescription status	Prescription use
Biologic classification	Not applicable
Biosimilar pathway	Not applicable
Primary regulatory risk	Manufacturing continuity, labeling compliance and supply availability

The product’s regulatory value is tied to its established labeling, known clinical use and hospital familiarity. New entrants would generally need to demonstrate pharmaceutical equivalence, bioequivalence where applicable, manufacturing quality and adequate labeling through the applicable FDA abbreviated or full approval pathway.

Cystografin is not comparable to an injectable systemic contrast agent in terms of clinical positioning. Its route of administration and narrow indication create a specialized market, with purchasing decisions often made at the hospital or health-system level.

How large is the Cystografin market?

Public sources do not separately disclose Cystografin sales, unit volumes or operating profit. The product is generally included within broader diagnostic-imaging or contrast-media portfolios rather than reported as a standalone commercial franchise.

The addressable market is narrow for four reasons:

Cystography is a specialized procedure.
Many urinary-tract investigations can use ultrasound, cross-sectional imaging or alternative contrast protocols.
The product is used episodically rather than chronically.
Several contrast agents can compete for selected lower-urinary-tract imaging procedures.

The relevant market is therefore better measured through procedure volume and institutional purchasing than through prescription counts.

Primary demand drivers

Demand is supported by:

Pediatric urology procedures
Evaluation of vesicoureteral reflux
Trauma-related bladder imaging
Postoperative diagnostic protocols
Availability of radiology and urology services
Hospital preference for established, labeled contrast products

Demand constraints

Demand is limited by:

Expansion of ultrasound-based pediatric imaging
Reduced use of invasive catheter-based diagnostics where clinically appropriate
Hospital budget controls
Generic or alternative contrast procurement
Procedure deferral and changes in radiology utilization
Concentration of demand among a small number of institutional buyers

Cystografin’s market is therefore defensive but not high growth. It has clinical utility in specific procedures, yet its total revenue opportunity is constrained by the size of the procedure pool.

What is the financial trajectory of Cystografin?

Cystografin’s product-level financial trajectory is not publicly available. Its manufacturer and distributor do not report revenue, gross margin, volume or EBITDA for the product as a separate line item in publicly accessible corporate disclosures.

The most supportable financial characterization is:

Financial metric	Publicly disclosed status
Annual Cystografin revenue	Not separately reported
Product-level growth rate	Not publicly reported
Gross margin	Not publicly reported
Manufacturing cost	Not publicly reported
Market share	Not publicly reported
Customer concentration	Not publicly reported
Product-specific guidance	Not publicly reported

The commercial trajectory is likely mature and relatively stable, with revenue determined by three factors:

Procedure volume
Net price after hospital contracting and distributor discounts
Product availability

Volume growth is likely limited because Cystografin addresses a narrow procedure category. Pricing may provide some revenue support, particularly where the product has few directly substitutable products available during a supply disruption. That pricing power is constrained by hospital formularies, group purchasing organizations and the availability of other iodinated contrast media.

A mature contrast product can remain commercially valuable even with modest sales because manufacturing, regulatory and distribution infrastructure is already established. The main financial risk is not patent expiry alone. It is the loss of volume to alternative imaging methods, low-cost competitors or procurement substitution.

Which companies compete with Cystografin?

Cystografin competes in a specialized segment of the broader radiopaque contrast-media market. Competitive pressure comes from both products and procedures.

Product-level competition

Potential competitive categories include:

Other diatrizoate-based contrast products
Generic iodinated contrast products approved for comparable use
Alternative intravesical radiographic contrast agents
Hospital-compounded or institutionally sourced alternatives where permitted
Contrast products used under physician-directed or protocol-specific practice

The most relevant comparison is not necessarily molecule-to-molecule competition. Hospitals may compare products based on:

FDA labeling
Concentration and package size
Catheter administration requirements
Supply reliability
Contract price
Radiology department familiarity
Adverse-event profile
Reimbursement and procedure economics

Procedure-level competition

Cystografin also faces substitution from:

Renal and bladder ultrasound
Contrast-enhanced ultrasound in selected settings
CT cystography
MRI-based urinary-tract imaging
Noncontrast diagnostic protocols
Observation or clinical management without immediate invasive imaging

These alternatives do not replace Cystografin in every indication. They can reduce the number of catheter-based radiographic examinations performed, particularly when pediatric or trauma protocols evolve.

What patents protect Cystografin?

Cystografin is a legacy diatrizoate contrast product. The key commercial protections are likely regulatory approval, manufacturing know-how, supply continuity and customer relationships rather than a new molecular patent estate.

Composition-of-matter protection

Diatrizoate is an established small molecule. Any original composition-of-matter patent protection would have expired long before the current commercial period. Cystografin therefore should not be analyzed like a recently launched branded small molecule with a 20-year patent runway.

Formulation patents

The commercial product depends on formulation parameters such as:

Diatrizoate concentration
Salt composition
Excipients
Osmolality
Sterility
Container and closure system
Stability during storage

Those characteristics can be protected by formulation, manufacturing or process patents in some product portfolios. Public labeling alone does not establish that active, enforceable Cystografin-specific formulation patents remain in force.

Orange Book status

The FDA Orange Book is the relevant source for identifying approved drug applications and any listed patents or exclusivity associated with a product. Orange Book listings can change through patent-listing updates, delistings and regulatory amendments. (U.S. Food and Drug Administration, 2024)

A current product-specific patent conclusion should distinguish between:

Patents listed for the approved drug application
Expired patents
Unexpired patents
Pediatric exclusivity
Regulatory exclusivity
Patents covering a specific method of use rather than the product itself

Cystografin’s mature status means patent expiry is unlikely to create a newly emerging loss-of-exclusivity event comparable to a branded blockbuster. The more relevant question is whether any current listing blocks an abbreviated application or whether market access depends primarily on manufacturing and supply capabilities.

When does Cystografin lose exclusivity?

Cystografin’s original molecular exclusivity has already expired because diatrizoate is an established contrast agent. There is no publicly evident basis for treating the product as protected by a current composition-of-matter patent.

The practical exclusivity profile is therefore:

Exclusivity type	Commercial relevance
Original compound patent	Expired
New chemical entity exclusivity	Not relevant to the current product
Biosimilar exclusivity	Not applicable
Orphan-drug exclusivity	Not a principal product characteristic
Pediatric exclusivity	No current protection established from public product information
Formulation or process patents	Must be assessed against current patent and Orange Book records
Regulatory approval and labeling	Remain commercially relevant

A product can retain brand value after patent expiry if competitors do not enter, manufacturing is difficult or the market is too small to justify development costs. That appears more relevant to Cystografin than classic patent exclusivity.

Are there Paragraph IV challenges to Cystografin?

No widely reported Paragraph IV litigation involving Cystografin is identified in the principal public litigation and regulatory sources commonly used for Hatch-Waxman analysis.

A Paragraph IV challenge would require an ANDA applicant to certify that a listed patent is invalid, unenforceable or not infringed. If no active Orange Book patent blocks an ANDA, an applicant could pursue a different certification pathway. (U.S. Food and Drug Administration, 2024)

The absence of widely reported litigation is consistent with a small, mature market in which:

Potential sales may not justify costly patent litigation.
The product may have limited active patent barriers.
Entrants may focus on supply and commercial execution rather than litigation.
Hospitals may accept multiple equivalent or substitutable products.

This does not establish that no ANDA activity exists. It indicates that Cystografin has not generated the public Paragraph IV litigation profile associated with major branded products.

What generic entry risks exist for Cystografin?

Generic entry risk is real but may be economically limited by the size of the market.

Primary generic-entry risks

A lower-priced equivalent contrast product
Hospital conversion under group purchasing contracts
Supply shortages that encourage formulary substitution
Competitive offerings in comparable concentrations
A manufacturer using existing iodinated-contrast production capacity
Entry supported by established radiology distribution channels

Barriers to entry

Manufacturing and quality requirements may reduce the number of credible entrants. Relevant barriers include:

Sterile manufacturing
Consistent concentration and osmolality
Container-closure integrity
Stability data
Quality control for iodinated raw materials
FDA inspection readiness
Reliable packaging and inventory
Hospital contracting and distribution

These barriers are operational rather than necessarily patent-based. A small contrast product can be difficult to displace if the incumbent has reliable supply and a recognized label. The same product can lose share quickly if it experiences prolonged shortages or fails to meet hospital procurement requirements.

What manufacturing and supply-chain issues affect Cystografin?

Manufacturing continuity is a central commercial variable. Iodinated contrast products depend on specialized pharmaceutical production, sterile filling and quality systems. Broader contrast-media disruptions have shown that hospitals can face meaningful exposure when production is concentrated among a small number of suppliers.

For Cystografin, the main supply-chain risks are:

Limited manufacturing sites
Dependence on specialized sterile-fill capacity
Raw-material constraints
Packaging-component shortages
Batch-release delays
Distribution concentration
Inventory management at hospitals and wholesalers

A supply disruption can have two opposing effects. It can reduce the product’s revenue immediately through lost shipments. It can also accelerate permanent substitution if hospitals qualify competing products and revise their protocols.

What patent litigation or settlement agreements affect Cystografin?

No major publicly reported patent litigation or settlement agreement is associated with Cystografin in the principal sources used for branded-drug litigation analysis.

The absence of major litigation is commercially meaningful. It suggests that competitive outcomes are more likely to be determined by:

FDA approval status
Product availability
Contract pricing
Hospital purchasing
Procedure volume
Clinical protocol adoption

rather than by a high-value patent settlement that delays generic entry.

Does Cystografin have biosimilar risk?

No. Biosimilar risk is not applicable because Cystografin is a conventional small-molecule drug product, not a biologic. Any competitive entry would occur through generic, abbreviated drug-application or other conventional drug pathways, subject to FDA requirements.

The relevant substitution risk is generic and therapeutic, not biosimilar.

How does Cystografin compare with alternative imaging products?

Factor	Cystografin	Ultrasound	CT cystography	MRI urinary-tract imaging
Invasive catheterization	Usually required	Usually not required	Usually required	Usually not required
Ionizing radiation	Yes	No	Yes	No
Main commercial use	Bladder and lower urinary-tract radiography	Broad urinary and pediatric imaging	Trauma and complex anatomy	Selected soft-tissue and urinary-tract evaluations
Product revenue exposure	Contrast purchase plus procedure volume	Equipment and procedure volume	CT procedure plus contrast where used	MRI procedure and equipment
Substitution risk	Moderate	High in selected pediatric settings	Moderate	Selective
Main limitation	Invasive procedure and narrow indication	Operator and diagnostic limitations	Radiation and cost	Availability, cost and procedure time

Cystografin remains relevant where radiographic bladder filling and dynamic voiding assessment are clinically important. Its position is weaker where ultrasound or other noninvasive modalities provide adequate diagnostic information.

What is the commercial outlook for Cystografin?

The base-case outlook is a stable-to-declining mature-product profile rather than material growth.

Base case

Revenue remains supported by established clinical protocols, recurring hospital demand and a limited number of direct substitutes. Unit growth is modest, while price and procurement conditions determine net sales.

Downside case

Revenue declines as hospitals shift toward ultrasound or other imaging methods, adopt competing contrast products, or reduce use of invasive cystography. A supply interruption could accelerate conversion to alternative products.

Upside case

Revenue improves if procedure volumes recover, competing products face shortages, or the manufacturer secures favorable hospital contracts. The upside is constrained by the narrow indication and limited expansion opportunities.

Financial exposure assessment

Risk or opportunity	Assessment
Market growth	Low
Patent-driven revenue protection	Low to moderate, depending on current listings
Generic threat	Moderate
Biosimilar threat	None
Supply-chain sensitivity	Moderate to high
Pricing power	Limited, but can improve during shortages
Clinical substitution risk	Moderate
Revenue disclosure quality	Low because product-level sales are not reported
Probability of blockbuster-style erosion	Not applicable
Long-term trajectory	Mature, niche and likely flat to declining

Key Takeaways

Cystografin is a mature intravesical diatrizoate contrast product used primarily for retrograde cystography and voiding cystourethrography.
Its market is specialized and procedure-driven, with demand concentrated in hospitals, radiology departments and pediatric urology.
Public filings do not separately disclose Cystografin revenue, volume or profitability.
Original molecular patent protection has expired; current commercial protection is more likely to depend on regulatory status, supply reliability, manufacturing quality and contracting.
No major publicly reported Paragraph IV litigation or patent settlement is associated with the product.
Biosimilar competition is not applicable.
Generic and therapeutic substitution risks are moderate, while supply-chain execution is a major commercial variable.
The likely financial trajectory is mature and stable to declining, with limited structural growth.

FAQs About Cystografin Market and Patent Risk

Is Cystografin still FDA approved?

Yes. Cystografin is an FDA-approved prescription iodinated contrast agent for labeled lower-urinary-tract imaging procedures, including retrograde cystography and voiding cystourethrography. (U.S. Food and Drug Administration, 2023a)

Is Cystografin a generic drug?

Cystografin is a branded product containing an established diatrizoate contrast formulation. Competitive products may be approved through generic or other conventional drug pathways, but the brand itself is not a biologic and does not have biosimilar competition.

Does Cystografin have active Orange Book patents?

The relevant answer depends on the current FDA Orange Book record for the applicable drug application. The product’s original compound protection is expired, and any remaining protection would more likely involve formulation, process or method-of-use claims than a new chemical entity patent. (U.S. Food and Drug Administration, 2024)

What could cause Cystografin sales to decline?

The main causes would be lower cystography procedure volumes, substitution by ultrasound or other imaging modalities, hospital conversion to competing contrast products, pricing pressure and supply disruptions.

Is Cystografin commercially attractive for a generic manufacturer?

The product may offer a defensible niche for a manufacturer with sterile manufacturing capacity, regulatory expertise and hospital distribution. Its limited market size may make returns dependent on low development costs, reliable supply and access to institutional contracts rather than on high unit volume.

References

U.S. Food and Drug Administration. (2023a). Cystografin and Cystografin Dilute prescribing information. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (2023b). Drug approval package and labeling information for iodinated radiographic contrast agents. FDA.
DailyMed. (2024). Cystografin: Diatrizoate meglumine injection, solution. National Library of Medicine. https://dailymed.nlm.nih.gov/

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	992
Drug Prices:	Drug price information for CYSTOGRAFIN
What excipients (inactive ingredients) are in CYSTOGRAFIN?	CYSTOGRAFIN excipients list
DailyMed Link:	CYSTOGRAFIN at DailyMed

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

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