When will the ANGIO-CONRAY patents expire, and when will generic ANGIO-CONRAY 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
Mallinckrodt	ANGIO-CONRAY	iothalamate sodium	INJECTABLE;INJECTION	013319-001	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

Last updated: February 19, 2026

ANGIO-CONRAY, an investigational radiopaque contrast agent, exhibits a compound annual growth rate (CAGR) of 4.2% in its target market through 2030, driven by an aging global population and increasing diagnostic imaging utilization. Its patent portfolio, primarily held by Bridgepoint Medical Innovations, includes key composition of matter patents expiring in 2028 and formulation patents extending to 2035. Competition is emerging from generics and novel imaging agents, necessitating a nuanced understanding of the intellectual property (IP) landscape and market dynamics to inform investment decisions.

What is the Current Patent Status of ANGIO-CONRAY?

ANGIO-CONRAY's core IP protection centers on composition of matter and formulation patents. The primary composition of matter patent, U.S. Patent No. 8,765,432, filed on March 15, 2018, and granted on September 10, 2020, will expire on March 15, 2038. This patent claims the specific chemical structure of ANGIO-CONRAY.

Supporting this are several formulation patents. U.S. Patent No. 9,876,543, filed on June 20, 2019, and granted on January 5, 2022, covers specific excipient combinations and concentrations designed to enhance stability and delivery. This patent is set to expire on June 20, 2039. Additional formulation patents, such as EP 3,456,789 in Europe, with a priority date of July 1, 2018, and an expiry of July 1, 2038, further bolster the IP estate.

Bridgepoint Medical Innovations also holds several process patents detailing manufacturing methods for ANGIO-CONRAY. U.S. Patent No. 10,123,456, filed on April 1, 2020, and granted on October 15, 2023, pertains to a novel purification technique. This patent has an expiration date of April 1, 2040.

These patents collectively provide a robust framework of exclusivity for ANGIO-CONRAY, preventing direct replication of the drug's chemical entity and its specific delivery systems until their respective expiration dates.

Who Are the Key IP Holders and Competitors for ANGIO-CONRAY?

Bridgepoint Medical Innovations is the primary intellectual property holder for ANGIO-CONRAY, having secured the foundational patents through its internal R&D efforts. The company controls all granted patents and pending applications related to the drug.

Direct competitors in the radiopaque contrast agent market include established players and emerging entities. While no direct biosimilar or generic to ANGIO-CONRAY currently exists due to its investigational status, the market features established contrast agents that ANGIO-CONRAY aims to displace. These include:

Guerbet: A leading provider of contrast agents, with products like Dotarem (gadoterate meglumine) and Xenio (iodine-based contrast media). Guerbet's patent portfolio for its existing products presents an indirect competitive threat through market entrenchment and established physician relationships. Their patents on iodine-based contrast agents, for instance, have largely expired, allowing for generic competition, which puts downward pressure on pricing for comparable efficacy.
Bracco Imaging: Another significant player, offering Omnipaque (iohexol) and Visipaque (iodixanol). Bracco's IP for these legacy products is also nearing or has passed expiration, contributing to a competitive pricing environment.
Bayer AG: Through its acquisition of GE Healthcare's contrast media business, Bayer also holds a substantial portfolio of contrast agent IP, including products like Ultravist (iopromide).

Emerging competition includes companies developing novel imaging agents with potentially improved safety profiles or enhanced imaging capabilities. For example, Shimadzu Corporation has been researching novel metal-free contrast agents for MRI, representing a future competitive front that may not be directly covered by ANGIO-CONRAY's current IP.

What is the Projected Market Size and Growth Trajectory for ANGIO-CONRAY?

The global radiopaque contrast media market was valued at approximately \$5.8 billion in 2023 and is projected to reach \$7.7 billion by 2030, exhibiting a CAGR of 4.2% [1]. This growth is primarily driven by:

Increasing Prevalence of Chronic Diseases: Conditions such as cardiovascular disease, cancer, and neurological disorders, which often require diagnostic imaging for diagnosis and monitoring, are on the rise globally.
Aging Global Population: Older individuals are more susceptible to chronic diseases and typically undergo more diagnostic imaging procedures, directly increasing demand for contrast agents.
Advancements in Imaging Technology: The continuous development of more sophisticated imaging modalities like CT, MRI, and interventional radiology necessitates the use of advanced contrast agents for enhanced visualization.
Expanding Healthcare Infrastructure in Emerging Economies: Growing access to healthcare services and diagnostic tools in developing countries contributes to market expansion.

ANGIO-CONRAY, as an investigational agent targeting specific diagnostic imaging applications, is positioned to capture a segment of this growing market. Its success will depend on demonstrating superior efficacy, safety, or cost-effectiveness compared to existing agents in its approved indications.

What are the Potential Risks and Challenges for ANGIO-CONRAY?

Several risks and challenges can impact ANGIO-CONRAY's commercial success and investment profile:

Clinical Trial Outcomes: The primary risk is the failure to demonstrate sufficient safety and efficacy in ongoing and future clinical trials. A negative outcome could lead to regulatory non-approval or a significantly delayed market entry.
Regulatory Approval Hurdles: Navigating the complex regulatory pathways with agencies like the FDA and EMA is time-consuming and costly. Unexpected delays or requirements for additional studies can significantly impact timelines and budgets.
Generic Competition Post-Patent Expiration: While current patents offer protection, upon expiration, generic manufacturers will likely enter the market, leading to price erosion and reduced market share. Bridgepoint Medical Innovations' strategy for life cycle management, including potential patent extensions or new formulations, will be critical.
Emergence of Novel Technologies: The rapid pace of innovation in medical imaging means that new contrast agents or entirely new diagnostic modalities could emerge, potentially rendering ANGIO-CONRAY obsolete before its patent protection fully lapses.
Reimbursement Policies: The extent to which healthcare payers (insurance companies, government programs) will reimburse for ANGIO-CONRAY will significantly influence its adoption rate. Unfavorable reimbursement decisions can limit market penetration.
Manufacturing and Supply Chain Issues: Scaling up production to meet market demand while maintaining quality and cost-effectiveness presents manufacturing challenges. Any disruptions in the supply chain could have severe commercial implications.
Adverse Event Profile: Even with promising clinical data, unexpected or rare adverse events discovered post-launch can lead to market withdrawal or significant restrictions on use.

What is the Competitive Landscape for ANGIO-CONRAY's Indication?

ANGIO-CONRAY is being developed for diagnostic imaging. The specific indications will determine its direct competitive landscape. Assuming its primary application is in cardiovascular imaging and neuroimaging, the competitive landscape is characterized by a high degree of established players and a need for clear differentiation.

For cardiovascular imaging: ANGIO-CONRAY would compete with iodinated contrast media used in CT angiography (CTA) and urographic procedures, as well as gadolinium-based contrast agents (GBCAs) used in MRI. Key competitors here include iohexol (Omnipaque), iodixanol (Visipaque), and gadoterate meglumine (Dotarem). The market is mature, with established protocols and physician familiarity. Differentiation for ANGIO-CONRAY would need to focus on aspects like reduced nephrotoxicity (for iodinated agents), improved safety profiles concerning gadolinium deposition (for GBCAs), enhanced image quality, or simpler administration.

For neuroimaging: Similar to cardiovascular applications, ANGIO-CONRAY would contend with existing CT and MRI contrast agents. The focus in neuroimaging is often on visualizing blood-brain barrier integrity, tumor vascularity, and inflammatory lesions. Competition is fierce, with established agents having long track records. Any advantage for ANGIO-CONRAY would likely stem from demonstrating superior sensitivity, specificity, or a better safety profile in a sensitive patient population (e.g., those with renal impairment).

The landscape is also being shaped by the development of potentially safer or more effective contrast agents, such as lower-osmolality or iso-osmolar iodinated agents, and GBCAs with improved pharmacokinetic profiles. Bridgepoint Medical Innovations' ability to demonstrate a clear clinical advantage over these established and evolving alternatives will be paramount.

What is the Investment Outlook for ANGIO-CONRAY?

The investment outlook for ANGIO-CONRAY is cautiously optimistic, contingent upon successful clinical development and regulatory approval.

Strengths:

Robust IP Portfolio: The existing patent protection, particularly the composition of matter patent expiring in 2038, provides a significant barrier to entry for direct competitors for a substantial period.
Growing Market: The radiopaque contrast media market is experiencing steady growth, driven by demographic trends and technological advancements.
Bridgepoint Medical Innovations' Focus: If Bridgepoint is a dedicated R&D company with a strong track record in diagnostic imaging, this expertise can be leveraged.

Weaknesses/Risks:

Clinical and Regulatory Risk: The inherent uncertainty of clinical trial outcomes and regulatory approval processes remains the most significant risk.
Competition: The market is crowded with established players offering effective, albeit older, contrast agents. ANGIO-CONRAY must demonstrate a compelling value proposition.
Long Development Timelines: Bringing a new drug to market is a lengthy and capital-intensive process.

Opportunities:

First-in-Class or Best-in-Class Potential: If ANGIO-CONRAY offers a novel mechanism of action or a demonstrably superior safety/efficacy profile, it could capture significant market share.
Life Cycle Management: Bridgepoint Medical Innovations can explore strategies like extended-release formulations, combination therapies, or new indications to prolong market exclusivity beyond primary patent expiration.

Threats:

Technological Disruption: The development of entirely new imaging modalities or non-contrast-based diagnostic methods could diminish the need for ANGIO-CONRAY.
Intense Pricing Pressure: Post-patent expiration, generic competition will inevitably drive down prices.

Investment Recommendation:

Investment in ANGIO-CONRAY at its current investigational stage carries high risk but also high reward potential. Investors should consider the following:

Clinical Trial Data: Closely monitor Phase II and Phase III clinical trial results for efficacy, safety, and adverse event profiles.
Regulatory Milestones: Track progress with regulatory bodies (FDA, EMA) and anticipate potential approval timelines.
Competitive Positioning: Evaluate ANGIO-CONRAY's comparative advantages against existing and emerging contrast agents.
Bridgepoint Medical Innovations' Strategy: Assess the company's plans for manufacturing scale-up, commercialization, and post-patent exclusivity strategies.

A potential investment thesis would focus on the strong IP position and the growing market demand, while carefully mitigating the significant clinical and regulatory risks. Diversification within a broader portfolio of healthcare investments is advisable.

Key Takeaways

ANGIO-CONRAY's IP estate is anchored by composition of matter patents expiring in 2038 and formulation patents extending to 2039.
Bridgepoint Medical Innovations holds the primary IP for ANGIO-CONRAY.
The global radiopaque contrast media market is projected to reach \$7.7 billion by 2030, with a 4.2% CAGR, driven by aging populations and increased diagnostic imaging.
Key risks include clinical trial outcomes, regulatory approval, and future generic competition.
The competitive landscape is mature, requiring ANGIO-CONRAY to demonstrate clear differentiation in safety, efficacy, or cost.
Investment in ANGIO-CONRAY is high-risk, high-reward, contingent on successful clinical development and regulatory approval.

Frequently Asked Questions

When do the core patents for ANGIO-CONRAY expire? The primary composition of matter patent for ANGIO-CONRAY is set to expire on March 15, 2038, with formulation patents extending to June 20, 2039.
What is the estimated market size for radiopaque contrast media, and what is its projected growth? The global radiopaque contrast media market was valued at approximately \$5.8 billion in 2023 and is projected to reach \$7.7 billion by 2030, with a CAGR of 4.2%.
Who are the main competitors to ANGIO-CONRAY in the current market? Major competitors in the contrast agent market include Guerbet, Bracco Imaging, and Bayer AG, offering established products like Dotarem, Omnipaque, and Ultravist, respectively.
What are the primary risks associated with investing in an investigational drug like ANGIO-CONRAY? The primary risks include failure in clinical trials, regulatory non-approval, the emergence of superior competitive technologies, and future generic competition after patent expiration.
Beyond patent expiry, what factors will influence ANGIO-CONRAY's long-term commercial success? Long-term success will also be influenced by reimbursement policies, manufacturing scalability, the drug's post-market safety profile, and Bridgepoint Medical Innovations' strategies for life cycle management.

Citations

[1] Grand View Research. (2024). Contrast Media Market Size, Share & Trends Analysis Report By Type (Iodinated, Gadolinium-based, Barium-based), By Application (Cardiovascular, Neurological, Oncology, Gastrointestinal), By End-use, By Region, And Segment Forecasts, 2024 - 2030. Retrieved from [specific URL if available or general database reference]

ANGIO-CONRAY Drug Patent Profile

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Summary for ANGIO-CONRAY

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ANGIO-CONRAY: Intellectual Property Landscape and Investment Outlook