Gadoxetate disodium - Generic Drug Details

What are the generic sources for gadoxetate disodium and what is the scope of freedom to operate?

Gadoxetate disodium is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gadoxetate disodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	9
Patent Applications:	528
What excipients (inactive ingredients) are in gadoxetate disodium?	gadoxetate disodium excipients list
DailyMed Link:	gadoxetate disodium at DailyMed

Recent Clinical Trials for gadoxetate disodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 4
National Cancer Institute (NCI)	Phase 4
Bracco Diagnostics, Inc	Phase 4

See all gadoxetate disodium clinical trials

Pharmacology for gadoxetate disodium

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for gadoxetate disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008		RX	Yes	Yes
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013		RX	Yes	No

Expired US Patents for gadoxetate disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008

Gadoxetate disodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Gadoxetate Disodium

Introduction

Gadoxetate disodium, known by the trade names Primovist in Europe and Australia/New Zealand and Eovist in the United States, is a hepatospecific paramagnetic gadolinium-based contrast agent. It is primarily used in MRI liver imaging, particularly for characterizing focal liver lesions. Here, we delve into the market dynamics and financial trajectory of this crucial diagnostic tool.

Market Demand and Clinical Utility

Gadoxetate disodium fills a specific niche in the medical imaging market, particularly in the diagnosis and characterization of liver lesions. Its unique pharmacological properties, such as its ability to distribute into hepatocytes and bile ducts during the hepatobiliary phase, make it invaluable for distinguishing between various types of liver lesions, including focal nodular hyperplasia (FNH), adenoma, and hepatocellular carcinoma (HCC)[1].

Competitive Landscape

The market for liver-specific MRI contrast agents is relatively specialized. Gadoxetate disodium stands out due to its high hepatic uptake, with approximately 50% of the injected dose being taken up by the liver, significantly higher than other agents like gadobenate dimeglumine (MultiHance), which has only a 5% hepatic uptake[1].

Pricing and Cost Considerations

The cost of gadoxetate disodium can vary based on the region and healthcare system. However, it is generally considered a high-value diagnostic tool due to its specificity and the critical information it provides. The cost-benefit analysis often favors its use in cases where accurate liver lesion characterization is crucial for patient outcomes.

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of gadoxetate disodium. Like all gadolinium-based contrast agents, its use is subject to scrutiny, especially in patients with renal impairment, due to the risk of nephrogenic systemic fibrosis. Regulatory bodies such as the FDA closely monitor the safety and efficacy of these agents, which can impact market availability and pricing[1].

Market Size and Growth

The market for MRI contrast agents, including gadoxetate disodium, is influenced by the growing demand for advanced diagnostic imaging. The increasing incidence of liver diseases, such as HCC, and the need for precise diagnostic tools drive the demand for gadoxetate disodium. The market size is expected to grow as healthcare systems invest more in advanced imaging technologies.

Financial Trajectory

Revenue Streams

The revenue generated by gadoxetate disodium comes primarily from its use in clinical settings. Hospitals and imaging centers purchase the agent based on its recommended dosage and the number of procedures performed. The revenue is also influenced by reimbursement policies from insurance providers, which can vary significantly by region.

Cost of Production and Distribution

The production and distribution costs of gadoxetate disodium are factors that influence its pricing. These costs include the raw materials, manufacturing process, regulatory compliance, and distribution logistics. Companies like Bayer, which markets Primovist and Eovist, invest heavily in research, development, and marketing, which are reflected in the final product cost.

Profit Margins

The profit margins for gadoxetate disodium are substantial due to its high demand and limited competition in the liver-specific MRI contrast agent market. However, these margins can be affected by regulatory changes, competition from newer agents, and fluctuations in raw material costs.

Industry Dynamics

Generic Competition

Unlike many pharmaceuticals, gadoxetate disodium is not subject to generic competition in the same way. Its unique chemical structure and specific use case make it difficult for generic alternatives to enter the market. However, the generic drug industry dynamics, as studied in other contexts, suggest that if a generic version were to be developed, it would significantly impact the market pricing and profitability[3].

Technological Advancements

Advancements in MRI technology and the development of new contrast agents can impact the market for gadoxetate disodium. New agents with improved safety profiles or enhanced diagnostic capabilities could potentially challenge its market position.

Challenges and Limitations

Safety Concerns

Gadoxetate disodium, like other gadolinium-based agents, carries the risk of nephrogenic systemic fibrosis in patients with severe renal impairment. This safety concern necessitates careful patient selection and monitoring, which can limit its use in certain patient populations[1].

Clinical Limitations

The agent has specific clinical limitations, such as causing severe respiratory motion artifacts in the arterial phase, which can limit the evaluation of certain lesions. It is also not the best choice for evaluating hemangiomas or inflammatory diseases[1].

Future Outlook

The future outlook for gadoxetate disodium is positive, driven by the increasing need for precise liver imaging. Here are some key points:

Growing Demand for Advanced Imaging

The demand for advanced diagnostic imaging is expected to grow, driven by an aging population and an increase in liver diseases.

Technological Innovations

Advancements in MRI technology and contrast agent development will continue to shape the market. However, gadoxetate disodium's unique properties make it likely to remain a valuable tool.

Regulatory and Safety Considerations

Ongoing regulatory scrutiny and safety monitoring will be crucial. Any significant safety concerns or regulatory changes could impact its market trajectory.

Key Takeaways

• Clinical Utility: Gadoxetate disodium is a critical tool for liver lesion characterization due to its hepatospecific properties.
• Market Demand: The demand is driven by the need for precise diagnostic imaging in liver diseases.
• Competitive Landscape: It holds a strong position in the market due to its high hepatic uptake and limited competition.
• Financial Trajectory: Revenue is influenced by clinical use, reimbursement policies, and production costs.
• Challenges and Limitations: Safety concerns and clinical limitations must be carefully managed.

FAQs

Q: What is gadoxetate disodium used for?

A: Gadoxetate disodium is used exclusively in MRI liver imaging, particularly for characterizing focal liver lesions.

Q: How does gadoxetate disodium distribute in the body?

A: It distributes into the vascular and extravascular spaces and then into hepatocytes and bile ducts during the hepatobiliary phase.

Q: What are the safety concerns associated with gadoxetate disodium?

A: It carries the risk of nephrogenic systemic fibrosis in patients with severe renal impairment.

Q: How does gadoxetate disodium compare to other liver-specific MRI contrast agents?

A: It has a significantly higher hepatic uptake compared to other agents like gadobenate dimeglumine.

Q: What are the potential future challenges for gadoxetate disodium in the market?

A: Future challenges include technological innovations, regulatory changes, and the development of new contrast agents.

Sources

1. Radiopaedia.org: Gadoxetate disodium.
2. UMMS.org: Standard charges for diagnostic radiology services.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. MedChemExpress: Gadoxetate disodium (Gd-EOB-DTPA disodium).
5. eScholarship@UMassChan: Recently Published.