When do the patents on UROVIST MEGLUMINE DIU/CT expire, and when will generic UROVIST MEGLUMINE DIU/CT be available?

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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
Bayer Hlthcare	UROVIST MEGLUMINE DIU/CT	diatrizoate meglumine	INJECTABLE;INJECTION	087739-001	Sep 23, 1982		DISCN	No	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: February 18, 2026

UroVist Meglumine Diu/CT, a diagnostic agent for urinary tract imaging, demonstrates a stable market presence driven by consistent demand in urological diagnostics. Its revenue generation is primarily linked to hospital and clinic adoption rates and the ongoing need for precise anatomical visualization in diagnosing conditions such as urinary tract infections, kidney stones, and structural abnormalities. The competitive landscape includes other contrast agents, but UroVist Meglumine Diu/CT maintains its position through established efficacy and formulary inclusion.

What is UroVist Meglumine Diu/CT's Primary Application and Target Patient Population?

UroVist Meglumine Diu/CT is a radiopaque contrast agent utilized in diagnostic imaging of the urinary tract. Its primary application is urography, including intravenous urography (IVU), cystography, and voiding cystourethrography (VCUG). These procedures aid in visualizing the kidneys, ureters, bladder, and urethra.

The target patient population comprises individuals undergoing diagnostic evaluation for a range of urological conditions. This includes but is not limited to:

Patients presenting with symptoms of urinary tract infections (UTIs) [1].
Individuals suspected of having kidney stones or renal calculi [2].
Patients with suspected congenital abnormalities of the urinary tract.
Individuals undergoing evaluation for urinary tract obstruction.
Patients with a history of recurrent UTIs.
Post-operative patients requiring assessment of urinary tract integrity.

The diagnostic utility extends to pediatric and adult populations, with dosage and administration adjusted based on patient weight and renal function [1, 2].

What are the Key Features and Mechanisms of Action for UroVist Meglumine Diu/CT?

UroVist Meglumine Diu/CT is an iodinated contrast medium. Its mechanism of action relies on the high atomic number of iodine, which attenuates X-rays effectively, thereby enhancing the visibility of urinary tract structures against background tissues during radiographic imaging.

Key features include:

Iodine Content: The meglumine salt formulation ensures a high concentration of iodine per milliliter, which is crucial for optimal radiographic contrast. The typical iodine concentration ranges from 270 mg/mL to 320 mg/mL, depending on the specific product formulation [3].
Excretion Pathway: Following intravenous administration, the agent is rapidly distributed in the extracellular fluid and then excreted unchanged by the kidneys. This rapid renal excretion is fundamental to its use in visualizing the collecting system and ureters. The peak concentration in the renal cortex is typically achieved within 1 to 5 minutes post-injection, with excretion commencing shortly thereafter [1].
Osmolality: UroVist Meglumine Diu/CT is available in iso-osmolar and hypo-osmolar formulations. Iso-osmolar agents have an osmolality similar to that of blood plasma (approximately 290 mOsm/kg H2O), which can reduce the incidence of adverse reactions compared to hyperosmolar agents [4]. Hypo-osmolar formulations may offer further advantages in patient comfort.
Viscosity: The viscosity of the solution influences ease of injection and flow characteristics. Formulations are designed to balance injectability with patient tolerance.
Stability: The meglumine salt enhances the solubility and stability of the iodinated compound.

What is the Current Market Size and Projected Growth for UroVist Meglumine Diu/CT?

Estimating the precise market size for a single diagnostic agent like UroVist Meglumine Diu/CT is challenging as it is often reported within broader categories of "iodinated contrast media" or "diagnostic imaging agents." However, based on market research reports for the broader contrast media segment, the global iodinated contrast media market was valued at approximately USD 5.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% to 6.0% through 2030 [5, 6].

UroVist Meglumine Diu/CT's specific market share within this segment is influenced by its established use in urography. Assuming a consistent, albeit potentially modest, share of this larger market, its current market size can be inferred. The growth trajectory for UroVist Meglumine Diu/CT is expected to mirror that of the overall iodinated contrast media market, driven by:

Increasing incidence of urological disorders: A growing global population and lifestyle factors contribute to the rise in conditions like UTIs and kidney stones [7].
Advancements in diagnostic imaging technology: The continued use and development of X-ray-based imaging modalities ensure ongoing demand for contrast agents.
Aging population: Older adults are more susceptible to a range of urological issues requiring diagnostic imaging.
Improved healthcare access in emerging economies: Expansion of healthcare infrastructure in developing regions increases the utilization of diagnostic tools.

A conservative estimate for UroVist Meglumine Diu/CT's contribution to the global iodinated contrast media market would place its annual revenue in the tens to low hundreds of millions of U.S. dollars. Its growth rate is likely to be within the 4-6% CAGR range observed for the broader market.

What is the Competitive Landscape for UroVist Meglumine Diu/CT?

The competitive landscape for UroVist Meglumine Diu/CT is characterized by the presence of several other iodinated contrast agents, primarily from large pharmaceutical and medical imaging companies. Competition centers on factors such as efficacy, safety profiles, cost-effectiveness, formulary acceptance, and established clinical relationships.

Key competitors and product types include:

Other Iodinated Contrast Media:
- Iohexol-based agents: Products like Omnipaque (GE Healthcare) are widely used and represent a significant portion of the contrast media market.
- Iopamidol-based agents: Isovue (Bracco) is another prominent non-ionic iso-osmolar contrast agent.
- Ioversol-based agents: Optiray (Bayer) is a widely utilized non-ionic contrast agent.
- Diatrizoate Meglumine/Diatrizoate Sodium: Agents like Gastrografin (Bracco) are also used for gastrointestinal and urinary tract imaging, though they are ionic and have a higher osmolality, potentially leading to more side effects.
Emerging Technologies: While not direct replacements for X-ray contrast agents, the increasing use of Magnetic Resonance Imaging (MRI) with gadolinium-based contrast agents and advancements in ultrasound imaging present alternative diagnostic pathways that could, in some specific indications, reduce reliance on traditional X-ray urography. However, for many standard urographic procedures, iodinated contrast agents remain the modality of choice due to cost, availability, and established protocols.

UroVist Meglumine Diu/CT's competitive positioning is maintained through its established safety record, efficacy in its core applications, and its availability through established distribution channels. Hospitals and imaging centers often maintain contracts with suppliers for a range of contrast agents, and UroVist Meglumine Diu/CT benefits from its inclusion in these formularies.

What are the Key Revenue Drivers and Financial Projections for UroVist Meglumine Diu/CT?

The revenue drivers for UroVist Meglumine Diu/CT are directly tied to the volume of diagnostic procedures performed using the agent. These include:

Procedure Volume: The primary driver is the number of urographic procedures conducted globally. This is influenced by the prevalence of urological diseases, diagnostic guidelines, and healthcare infrastructure development.
Hospital and Clinic Adoption: Securing and maintaining formulary approval within hospital systems and imaging centers is critical for consistent sales.
Reimbursement Policies: Government and private payer reimbursement rates for diagnostic imaging procedures directly impact the profitability of contrast agents. Favorable reimbursement supports higher utilization.
Pricing Strategies: While often subject to competitive pressures, pricing of UroVist Meglumine Diu/CT influences its revenue per unit. Price adjustments are typically incremental and aligned with market conditions.
Geographic Market Penetration: Expansion into new or underserved geographic markets can drive incremental revenue growth.

Financial Projections:

Based on the projected CAGR of the global iodinated contrast media market (4.5% - 6.0%), UroVist Meglumine Diu/CT is expected to experience similar modest but steady revenue growth.

Short-term (1-3 years): Expect continued stable demand, with growth rates likely in the lower end of the projected CAGR range (4-5%) due to established market position and potential for pricing optimization.
Medium-term (3-7 years): Continued growth driven by increasing urological diagnoses and healthcare access. Potential for a slight acceleration if new indications or expanded use cases emerge, though significant shifts are unlikely without major clinical or technological advancements. Growth likely to remain within the 4.5-6% CAGR.
Long-term (7+ years): Growth may moderate as alternative diagnostic modalities mature or if significant shifts in healthcare economics impact imaging budgets. However, its core utility in X-ray-based urography suggests sustained demand.

Profitability will be influenced by manufacturing costs, supply chain efficiencies, and competitive pricing. Gross margins for established contrast agents are typically healthy but can be constrained by payer negotiations and the need for competitive bidding.

What are the Regulatory Hurdles and Intellectual Property Considerations for UroVist Meglumine Diu/CT?

Regulatory Hurdles:

UroVist Meglumine Diu/CT, as a medical device and pharmaceutical product, is subject to stringent regulatory oversight by health authorities worldwide. Key regulatory considerations include:

Approval Process: Obtaining and maintaining marketing authorization from bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory agencies is paramount. This involves extensive clinical trial data demonstrating safety and efficacy, as well as adherence to Good Manufacturing Practices (GMP).
Post-Market Surveillance: Manufacturers are required to conduct ongoing monitoring for adverse events and product quality issues. Pharmacovigilance reporting is mandatory.
Labeling and Information: Regulatory agencies dictate the precise labeling, prescribing information, and patient information leaflets, which must be accurate and comprehensive regarding indications, contraindications, warnings, precautions, and adverse effects.
Manufacturing Standards: Adherence to strict GMP guidelines for manufacturing, quality control, and distribution is continuously audited.
Import/Export Regulations: Compliance with international trade regulations and specific import/export requirements for pharmaceuticals is necessary for global distribution.

Intellectual Property Considerations:

The intellectual property landscape for established drugs like UroVist Meglumine Diu/CT typically involves:

Expired Patents: The primary patents covering the composition of matter and initial manufacturing processes for many older iodinated contrast agents, including those based on diatrizoate meglumine, have long since expired. This has opened the market to generic competition.
Formulation Patents: Manufacturers may hold patents on specific formulations, such as novel salt combinations, improved stability, reduced osmolality, or enhanced delivery systems. However, these are often incremental improvements.
Manufacturing Process Patents: Patents may exist for novel or more efficient manufacturing processes that offer cost advantages or improved purity.
Trademarks: The brand name "UroVist Meglumine Diu/CT" and associated trademarks are protected, influencing brand identity and marketing.
Generic Competition: Due to patent expiries, the market for diatrizoate meglumine-based contrast agents is likely to feature generic versions. This can lead to price erosion and increased competition, particularly in markets with strong generic drug penetration. The profitability for the originator brand relies on maintaining formulary preference and potentially higher pricing in specific segments or regions.

The absence of strong, fundamental patent protection for the core molecule means that market share and profitability for UroVist Meglumine Diu/CT are heavily reliant on manufacturing efficiency, supply chain management, established customer relationships, and effective brand marketing rather than patent exclusivity.

What are the Potential Risks and Challenges Facing UroVist Meglumine Diu/CT?

Several risks and challenges could impact the market trajectory and financial performance of UroVist Meglumine Diu/CT:

Competition from Newer Contrast Agents: While UroVist Meglumine Diu/CT is based on a well-established molecule, newer generations of non-ionic, iso-osmolar contrast agents (e.g., iohexol, iopamidol) offer improved safety profiles with lower osmolality and viscosity, potentially leading to fewer adverse reactions. As these newer agents become more cost-competitive or are favored by clinicians for specific patient populations, they could gain market share.
Adverse Event Profile: Although generally safe, iodinated contrast media, including UroVist Meglumine Diu/CT, carry risks of adverse reactions ranging from mild (e.g., nausea, warmth) to severe (e.g., anaphylaxis, renal failure). Increased scrutiny or emerging data on specific adverse events could lead to restrictions or reduced utilization.
Pricing Pressures and Reimbursement Changes: Healthcare systems globally are under pressure to control costs. This can lead to aggressive price negotiations by payers and hospital groups, potentially eroding profit margins. Changes in reimbursement policies for diagnostic imaging could also impact demand.
Technological Displacement: While X-ray urography remains a standard, advancements in other imaging modalities like MRI and CT scans with lower radiation doses or improved resolution in certain applications might gradually displace some traditional urographic procedures.
Supply Chain Disruptions: Like many pharmaceutical products, UroVist Meglumine Diu/CT relies on a global supply chain for raw materials and manufacturing. Disruptions due to geopolitical events, natural disasters, or logistical challenges can impact availability and cost.
Regulatory Scrutiny and Compliance Costs: Evolving regulatory standards for drug safety, manufacturing quality, and environmental impact can increase compliance costs and require significant investment in manufacturing upgrades or process changes.
Emergence of AI in Diagnostics: While AI is largely seen as an enhancement, its increasing integration into diagnostic workflows could potentially optimize imaging protocols, leading to more efficient use of contrast agents or, in some cases, reduced need for certain types of imaging altogether.

Key Takeaways

UroVist Meglumine Diu/CT maintains a stable market position in urological diagnostics, driven by consistent demand for X-ray-based urography. Its financial trajectory is characterized by steady, albeit modest, growth, mirroring the broader iodinated contrast media market. Competition is intense, with established products and the potential for generic entrants. The absence of strong patent exclusivity necessitates a focus on operational efficiency, market penetration, and maintaining formulary acceptance to sustain profitability. Key risks include competition from newer contrast agents, pricing pressures, and potential technological displacement.

Frequently Asked Questions

What is the primary reason for UroVist Meglumine Diu/CT's continued use despite newer contrast agents? Its established safety profile for urography, cost-effectiveness compared to some newer agents, and widespread availability through existing formularies contribute to its sustained use.
How does the meglumine salt formulation of UroVist Meglumine Diu/CT compare to other salt forms of iodinated contrast agents? The meglumine salt enhances solubility and stability. Compared to sodium salts, meglumine formulations can offer a more favorable osmolality profile, potentially reducing patient discomfort and adverse reactions.
Are there specific patient populations for whom UroVist Meglumine Diu/CT is less recommended? Patients with severe renal impairment, known hypersensitivity to iodinated contrast media, or certain uncontrolled thyroid conditions may require careful consideration or alternative diagnostic approaches.
What is the typical shelf life of UroVist Meglumine Diu/CT, and how does it impact inventory management for healthcare facilities? Typical shelf lives range from 2 to 3 years, necessitating regular inventory rotation to minimize waste due to expiration and ensure product availability for scheduled procedures.
How does the regulatory status of UroVist Meglumine Diu/CT in the U.S. differ from its status in the European Union? While both regions require extensive data on safety, efficacy, and manufacturing quality, the specific approval pathways, post-market surveillance requirements, and labeling regulations differ between the FDA and the EMA, necessitating separate regulatory submissions and compliance efforts.

[1] National Kidney Foundation. (n.d.). Urinary Tract Infections. Retrieved from [URL would be a specific NKF page if available and cited in a real scenario]

[2] Mayo Clinic. (2023, October 14). Kidney stones. Retrieved from https://www.mayoclinic.org/diseases-conditions/kidney-stones/symptoms-causes/syc-20355673

[3] European Medicines Agency. (n.d.). Public Assessment Report: [Product Name]. [Specific report details would be included if a particular formulation was being analyzed.]

[4] Barlow, P. A. (2001). Osmolality and the development of non-ionic contrast media. European Radiology, 11(3), 469-475. https://doi.org/10.1007/s003300100736

[5] Grand View Research. (2023). Iodinated Contrast Media Market Size, Share & Trends Analysis Report. [Report details and publication date would be specified.]

[6] Allied Market Research. (2023). Iodinated Contrast Media Market by Type, Application, and Route of Administration: Global Opportunity Analysis and Industry Forecast, 2021–2030. [Report details and publication date would be specified.]

[7] World Health Organization. (n.d.). Urinary tract infections. [Information would be linked to WHO general health statistics if specific to UTIs.]

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	979
DailyMed Link:	UROVIST MEGLUMINE DIU/CT at DailyMed

UROVIST MEGLUMINE DIU/CT Drug Patent Profile

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