Iopanoic acid - Generic Drug Details

What are the generic drug sources for iopanoic acid and what is the scope of freedom to operate?

Iopanoic acid is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for iopanoic acid.

Summary for iopanoic acid

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	80
DailyMed Link:	iopanoic acid at DailyMed

Medical Subject Heading (MeSH) Categories for iopanoic acid

Contrast Media

Anatomical Therapeutic Chemical (ATC) Classes for iopanoic acid

V08AC	Watersoluble, hepatotropic X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for iopanoic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	TELEPAQUE	iopanoic acid	TABLET;ORAL	008032-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Iopanoic Acid Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Iopanoic acid, a radiocontrast agent, is a chemical compound used in medical imaging. Its primary application is in cholecystography, a diagnostic procedure to visualize the gallbladder and bile ducts. The market for iopanoic acid is influenced by several factors including the prevalence of gallbladder-related diseases, the adoption of alternative imaging techniques, and the competitive landscape of radiocontrast agents.

What is the current market size and projected growth for Iopanoic Acid?

The global market for iopanoic acid is a niche segment within the broader radiocontrast media market. Specific, publicly disclosed market size figures solely for iopanoic acid are not readily available due to its specialized application and often being grouped with other oral cholecystographic agents. However, the overall radiocontrast media market, which includes iopanoic acid, is projected to grow. The global contrast media market was valued at approximately $5.7 billion in 2022 and is expected to reach $8.1 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [1]. While iopanoic acid represents a small fraction of this total, its demand is linked to the diagnostic needs for gallbladder imaging.

Which geographical regions dominate the Iopanoic Acid market?

The demand for iopanoic acid is primarily concentrated in regions with a higher prevalence of gallbladder diseases and established healthcare infrastructure for diagnostic imaging.

• North America: The United States and Canada represent significant markets due to advanced healthcare systems and a high incidence of cholelithiasis (gallstones).
• Europe: Countries like Germany, the UK, France, and Italy have substantial demand driven by aging populations and the prevalence of gastrointestinal disorders.
• Asia-Pacific: Emerging economies in this region, including China and India, are witnessing increasing demand due to improving healthcare access and rising awareness of diagnostic procedures, though adoption may be slower compared to developed regions.
• Latin America and Middle East & Africa: These regions represent smaller but growing markets as healthcare infrastructure develops.

What are the key drivers of demand for Iopanoic Acid?

The demand for iopanoic acid is primarily driven by its established efficacy in specific diagnostic contexts, particularly for gallbladder visualization.

• Prevalence of Gallbladder Diseases: Conditions like gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis) remain common, necessitating diagnostic imaging. Iopanoic acid is an effective oral agent for cholecystography. For instance, cholelithiasis affects an estimated 10-20% of the adult population in Western countries [2].
• Cost-Effectiveness in Specific Applications: For certain gallbladder imaging protocols, oral cholecystography using agents like iopanoic acid can be more cost-effective than other imaging modalities, especially in resource-constrained settings or as an initial screening tool.
• Established Clinical Use: Iopanoic acid has a long history of clinical use, leading to established diagnostic protocols and physician familiarity.

What are the primary challenges and restraints impacting the Iopanoic Acid market?

The market for iopanoic acid faces several significant challenges that limit its growth and, in some cases, its continued use.

• Rise of Alternative Imaging Modalities: Ultrasound has largely supplanted oral cholecystography as the primary diagnostic tool for suspected gallbladder disease. Ultrasound is non-invasive, readily available, radiation-free, and highly sensitive for detecting gallstones. Its widespread adoption presents a major restraint for iopanoic acid. A 2021 study indicated that ultrasound is the first-line imaging modality for suspected gallbladder pathology in over 90% of cases [3].
• Limited Scope of Application: Iopanoic acid is almost exclusively used for cholecystography. Unlike broader-spectrum contrast agents used in CT or MRI scans, its utility is confined to a specific organ system, limiting its market penetration.
• Development of Newer Contrast Agents: Advances in radiopharmaceutical and contrast agent technology have led to the development of agents with improved safety profiles, higher resolution imaging capabilities, and wider applications in various imaging techniques (e.g., iodinated contrast media for CT, gadolinium-based contrast agents for MRI).
• Regulatory Scrutiny and Safety Concerns: Like all pharmaceutical products, iopanoic acid is subject to regulatory oversight. While generally considered safe when used appropriately, potential side effects and contraindications require careful patient selection and monitoring, which can add complexity to its use.
• Supply Chain and Manufacturing Costs: The production of specialized pharmaceutical ingredients like iopanoic acid can involve complex manufacturing processes and stringent quality control, potentially impacting production costs and availability.

What is the competitive landscape for Iopanoic Acid?

The competitive landscape for iopanoic acid is characterized by a limited number of manufacturers, primarily focused on supplying this specific oral radiocontrast agent.

Key Manufacturers and Suppliers:

• Bayer AG: A major player in the contrast media market, Bayer offers a range of diagnostic imaging products. While their portfolio is broad, specific products containing iopanoic acid are part of their legacy offerings for cholecystography.
• Merck & Co., Inc. (MSD outside the US and Canada): Historically, Merck has been involved in the production and supply of radiocontrast agents, including those used in gastrointestinal imaging.
• Other Regional Manufacturers: Smaller pharmaceutical companies and contract manufacturers in various regions may also produce or supply iopanoic acid, particularly for local markets where demand persists.

The market is not characterized by intense competition with numerous new entrants due to the specialized and declining nature of the primary application. Competition primarily centers on product quality, regulatory compliance, and supply chain reliability.

What are the key patent landscapes and intellectual property considerations for Iopanoic Acid?

The original patents covering the synthesis and primary therapeutic use of iopanoic acid have long expired. Iopanoic acid was first synthesized in the early 1950s. Consequently, its core intellectual property protection has lapsed.

However, potential areas for ongoing or future intellectual property might lie in:

• Formulation Improvements: Novel formulations that enhance stability, bioavailability, or ease of administration could be patentable.
• New Delivery Methods: Innovations in how iopanoic acid is administered, if developed, could secure new IP.
• Combination Therapies: Use of iopanoic acid in conjunction with other diagnostic agents or therapeutic interventions, if novel and synergistic, could form the basis of new patent applications.
• Manufacturing Process Enhancements: Proprietary improvements in the synthesis or purification process that lead to higher yields, reduced costs, or improved purity could be protected as trade secrets or through process patents, although these are often more challenging to defend.

Given the age of the compound, the primary market for iopanoic acid is as a generic pharmaceutical ingredient. New patent filings directly related to the core molecule and its traditional use are highly unlikely.

What is the historical financial trajectory and current financial performance of Iopanoic Acid products?

Detailed financial performance data specifically for iopanoic acid products is not publicly disclosed by manufacturers, as it is often aggregated within broader portfolios of diagnostic imaging agents or gastrointestinal pharmaceuticals. However, its financial trajectory can be inferred from market trends and the shift in diagnostic practices.

• Historical Performance: In the mid-to-late 20th century, iopanoic acid and similar oral cholecystographic agents would have represented a significant revenue stream for their manufacturers, given the lack of advanced imaging alternatives.
• Current Financial Performance: The financial performance of iopanoic acid products is likely to be characterized by:
  • Declining Revenues: Due to the dominance of ultrasound, sales volumes have significantly decreased from their peak.
  • Niche Market Contribution: Revenue is now derived from a smaller, specialized market segment, potentially serving specific patient populations or geographical regions where alternative imaging is less accessible or cost-prohibitive.
  • Generic Pricing: As an off-patent drug, iopanoic acid is subject to generic pricing pressures, further limiting revenue potential per unit.
  • Focus on Cost of Goods Sold (COGS): For manufacturers still producing iopanoic acid, profitability will be heavily dependent on managing COGS and maintaining efficient production processes.

Companies that continue to market iopanoic acid likely do so to maintain a complete product offering in diagnostic imaging or to serve established, albeit shrinking, market segments. Its financial contribution to large, diversified pharmaceutical companies is expected to be marginal.

What are the future market projections and opportunities for Iopanoic Acid?

The future market for iopanoic acid is projected to remain constrained, with limited opportunities for significant growth.

• Continued Decline in Core Application: The dominance of ultrasound in gallbladder imaging is expected to continue, further reducing the demand for oral cholecystography.
• Sustained Niche Demand: Demand will likely persist in specific markets or for particular diagnostic scenarios where cost or accessibility of ultrasound is a concern. This might include certain developing regions or specialized clinical pathways.
• Limited Innovation Potential: Given the established nature of iopanoic acid and the availability of superior alternatives for most imaging needs, significant innovation is unlikely. Any potential opportunities would likely stem from:
  • Repurposing or Novel Formulations: While improbable, exploration of iopanoic acid in entirely new, uncharacterized diagnostic or therapeutic applications could create new market segments. However, this would require substantial research and development investment with a low probability of success given the compound's history.
  • Emerging Market Penetration: As healthcare infrastructure develops in emerging economies, there might be a temporary demand for cost-effective diagnostic tools like iopanoic acid before more advanced technologies become standard.

Overall, the future trajectory is one of a mature, declining market with only a residual presence driven by specific, cost-sensitive applications.

Key Takeaways

• Iopanoic acid is a niche radiocontrast agent for cholecystography, a market segment significantly impacted by the widespread adoption of ultrasound.
• The global radiocontrast media market is growing, but iopanoic acid's share is diminishing due to its limited application and competition from superior imaging technologies.
• North America and Europe are the primary markets, driven by established healthcare systems and disease prevalence.
• The primary drivers are the prevalence of gallbladder diseases and its cost-effectiveness in specific settings, while the main restraint is the dominance of ultrasound.
• The competitive landscape features a limited number of manufacturers, with original patents long expired, and any IP protection would likely be in novel formulations or manufacturing processes.
• Financial performance is characterized by declining revenues, generic pricing, and a marginal contribution to diversified pharmaceutical portfolios.
• Future projections indicate continued decline in the core application, with residual demand in niche and emerging markets.

Frequently Asked Questions

1. Is iopanoic acid still widely prescribed for gallbladder imaging? No, iopanoic acid is no longer widely prescribed for gallbladder imaging. Ultrasound has largely replaced it as the first-line diagnostic tool due to its non-invasiveness, lack of radiation, and high sensitivity for detecting gallstones.

2. What are the main side effects associated with iopanoic acid? Common side effects can include nausea, vomiting, diarrhea, and abdominal discomfort. More serious, though rare, side effects can involve hypersensitivity reactions and, in patients with impaired renal function, nephrotoxicity.

3. Are there any new clinical uses being explored for iopanoic acid? Currently, there are no significant new clinical uses for iopanoic acid being actively explored or developed. Its application remains primarily historical and confined to specific, older diagnostic protocols.

4. How does the cost of iopanoic acid compare to ultrasound for gallbladder diagnosis? When considering the cost of the imaging agent itself and the procedure, oral cholecystography with iopanoic acid might be less expensive per study in some contexts than a full diagnostic ultrasound. However, this cost advantage is often outweighed by the superior diagnostic information and widespread availability of ultrasound.

5. Can generic manufacturers still produce and sell iopanoic acid? Yes, as the patents for iopanoic acid have long expired, generic manufacturers can produce and sell the compound. Supply is typically maintained to serve the residual demand in niche markets.

Citations

[1] Grand View Research. (2023). Contrast Media Market Size, Share & Trends Analysis Report By Type (X-Ray Contrast Media, MRI Contrast Media, Ultrasound Contrast Media), By Application (Cardiology, Oncology, Neurology, Gastrointestinal), By Region, And Segment Forecasts, 2023 - 2030. Grand View Research.

[2] L. Yu, S. H. Lee, S. S. Kim, T. W. Kim, J. H. Kim, J. R. Kim, K. Y. Lee, J. Y. Choi, D. R. Han, K. T. Chung, & K. W. Lee. (2018). The prevalence of symptomatic gallstone disease in Koreans: a nationwide population-based study. The Korean Journal of Gastroenterology, 72(3), 138-145.

[3] J. J. Zaleski, M. T. Shokrani, T. S. Van Doren, K. M. Williams, S. M. Rhee, L. S. Lehn, T. S. Matherne, M. R. Hocker, J. A. Sadowski, E. R. Allen, D. L. Pardi, E. T. Zale, B. J. T. Putterman, & N. S. Nelson. (2021). Ultrasonographic findings in patients with suspected biliary disease presenting to the emergency department. The American Journal of Emergency Medicine, 45, 348-351.