Last Updated: May 3, 2026

iocetamic acid - Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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

Summary for iocetamic acid
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for iocetamic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CHOLEBRINE iocetamic acid TABLET;ORAL 017129-001 Approved Prior to Jan 1, 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

Investment Scenario and Fundamentals Analysis for Iocetamic Acid

Last updated: April 7, 2026

What Is Iocetamic Acid?

Iocetamic acid is a radiographic contrast agent used in medical imaging, specifically in cholangiography and angiography. It is an iodine-based compound that enhances visibility of biliary and vascular structures during imaging procedures. The compound is marketed under various brand names for diagnostic procedures and is primarily used in hospital settings.

Market Overview

The pharmaceutical market for contrast agents, including iodine-based compounds like iocetamic acid, has experienced steady growth driven by expanding diagnostic imaging procedures. The global contrast media market was valued at approximately USD 1.52 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030.

The market segments consist of:

  • Iodine-based contrast agents (including iocetamic acid)
  • Gadolinium-based agents
  • Carbon-based agents

Iodine-based contrast agents account for approximately 70% of diagnostic imaging procedures involving contrast media.

Market Drivers and Constraints

Drivers

  • Rising prevalence of cardiovascular and oncological diseases increases demand for diagnostic imaging.
  • Technological advances in imaging procedures improve diagnostic capabilities.
  • Increased healthcare expenditure fosters adoption of advanced contrast agents.
  • Growing usage of contrast media in developing countries as healthcare infrastructure improves.

Constraints

  • Concerns over adverse reactions, such as allergic responses and nephrotoxicity.
  • Stringent regulatory policies for approving and marketing contrast agents.
  • Competition from alternative imaging modalities (e.g., MRI with gadolinium).
  • Risks associated with iodine-based agents in specific patient populations.

Competitive Landscape

Key players include:

  • Bayer AG (marketed as Ultravist, Visipaque)
  • GE Healthcare (Omnipaque)
  • Bracco Imaging (Isovue)

Since iocetamic acid is a niche product, its market share is limited relative to these major competitors. Pharmaceutical companies focusing on radiology contrast agents emphasize safety profiles, imaging efficacy, and regulatory compliance to gain market share.

Regulatory Environment

  • The FDA and EMA regulate contrast media.
  • Clinically, safety concerns have tightened approval processes for new agents.
  • Existing products such as iocetamic acid face challenges related to adverse reaction profiles, affecting market expansion.

Investment Fundamentals

Patent and Regulatory Status

  • Iocetamic acid is off-patent or approaching patent expiry, which limits exclusivity.
  • Regulatory approvals vary across countries, influencing market access.
  • No recent major patent filings indicate limited R&D pipeline focus on this compound.

Manufacturing and Supply Chain

  • Manufacturing involves iodine synthesis, organic chemistry expertise, and rigorous quality controls.
  • Supply chain disruptions could impact availability, but established infrastructure mitigates risks.
  • Regulatory standards influence manufacturing costs and margins.

Financials and Market Position

  • Limited sales data available for iocetamic acid specifically; estimations rely on overall contrast media market growth.
  • Margins are ositive but competitive pressures from generics diminish profitability.
  • Investment outlook depends on broader trends in diagnostic imaging and regulatory actions.

Investment Risks and Opportunities

Risks Opportunities
Patent expiration diminishes exclusivity. Growing global imaging procedures boost demand.
Safety concerns limit clinical adoption. Innovations improving safety profiles could renew interest.
Regulatory hurdles restrict market expansion. Emerging markets increase adoption.
Competition from newer agents. Potential for position in niche or specialized imaging.

Conclusion

Investment in iocetamic acid presents limited opportunity due to its mature status, patent expiry, and competitive landscape. The broader contrast media market is expected to grow steadily, primarily driven by increasing diagnostic imaging utilization. Firms with a focus on safety improvements or geographic expansion might capitalize on niche segments; however, generic production and regulatory challenges constrain profitability.

Key Takeaways

  • Iocetamic acid is a well-established iodine-based contrast agent used in diagnostic imaging.
  • Market growth is aligned with overall contrast media market trends, around 4% CAGR through 2030.
  • Patent expiry and safety issues restrict competitive advantages; no significant recent innovation is observed.
  • Major competitors dominate, leaving limited market share prospects for iocetamic acid.
  • Opportunities relate mainly to expanding imaging procedures in emerging markets.

FAQs

1. What is the primary medical application of iocetamic acid?

It is used as a contrast agent in cholangiography and angiography imaging procedures.

2. How does the safety profile influence the market for iodine contrast agents?

Safety concerns, such as allergic reactions and nephrotoxicity, restrict clinical use and development, limiting market growth.

3. Are there recent patents or innovations associated with iocetamic acid?

No recent patents or significant R&D initiatives are publicly known, indicating limited pipeline activity.

4. How does competition affect the profitability of iocetamic acid?

Major competitors dominate the space; with patent expiry and generic availability, profit margins are under pressure.

5. What outlook exists for emerging markets regarding contrast agents?

Increasing healthcare infrastructure and diagnostic procedures in emerging markets could boost demand, offering some growth prospects.


References

[1] Grand View Research. (2023). Contrast Media Market Size, Share, & Trends Analysis.
[2] MarketsandMarkets. (2022). Contrast Media Market by Product, Application, Route of Administration, and Region.
[3] U.S. Food and Drug Administration. (2022). Regulatory Guidelines for Imaging Agents.
[4] European Medicines Agency. (2022). MEDDEV Guidance on Contrast Media Safety.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.