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
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
Bracco Diagnostics, Inc	Phase 4
University of Colorado, Denver	Phase 4
National Cancer Institute (NCI)	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	022090-002	Feb 4, 2013		RX	Yes	No
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008		RX	Yes	Yes

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

Market Dynamics and Financial Trajectory for Gadoxetate Disodium

Last updated: February 22, 2026

What Is Gadoxetate Disodium?

Gadoxetate disodium, marketed as Eovist or Primovist, is a paramagnetic contrast agent used in magnetic resonance imaging (MRI). It enhances liver imaging by selectively accumulating in hepatocytes, providing detailed liver structure visualization. Approved in multiple regions, including the U.S. (since 2012 by Bayer) and Europe, it generated approximately $274 million in sales globally in 2021.

Market Size and Growth

Current Market Valuation

• Global MRI contrast agent market: Valued at $2.9 billion in 2022; expected to reach $4.2 billion by 2027.
• Gadoxetate disodium share: Approximately 9.4% of the MRI contrast segment in 2022, translating to roughly $272 million.

Growth Drivers

• Increasing liver disease prevalence, notably hepatocellular carcinoma (HCC), accentuates demand.
• Rising adoption of advanced MRI techniques in diagnostics.
• Expanding approval in emerging markets.

Competitive Landscape

• Main competitors include gadopentetate dimeglumine, gadobutrol, and mangafodipir.
• Gadoxetate disodium’s unique hepatocyte-specific imaging provides a competitive edge but faces constraints from alternative agents like gadobenate dimeglumine, which also demonstrate hepatocyte uptake.

Pricing and Reimbursement Trends

• Average retail price per dose ranges from $150 to $250, varying by region.
• Reimbursement landscapes differ; in the U.S., Medicare reimburses approximately $180 per dose, with private insurers reimbursing up to $220.
• Price pressures emerge from generic competition, especially as patents expire and biosimilars advance.

Patent and Regulatory Landscape

Patent Status

• Bayer’s patent for Eovist expired in Europe in 2017, opening potential generic entry.
• The FDA approved several biosimilar or generic versions since patent expiry, impacting sales.

Regulatory Approvals

• Approved in the U.S., Europe, Japan, and parts of Asia-Pacific.
• Approval requirements include demonstration of safety, efficacy, and manufacturing quality.

Financial Trajectory

Revenue Projections

• Revenue declined modestly post-2017 patent expiry but maintained robustness due to high clinical adoption.
• For 2022, estimated global sales at nearly $275 million.
• Projected compound annual growth rate (CAGR) from 2023 to 2028: approximately 2.1%, reflecting stable but modest growth expectations.

Cost Structure and Margins

• Manufacturing costs are predominantly fixed, related to complex formulation and regulatory compliance.
• Gross margins hover around 70%, with net margins approximately 20% in top manufacturers' reports.
• Price erosion combining with generic competition could compress margins over the next five years.

Investment and Development Trends

• Few pipeline candidates similar to gadoxetate disodium are in advanced development, suggesting limited near-term pipeline pressure.
• Companies focusing on novel imaging agents with superior specificity or safety profiles represent potential future competitors.

Strategic Risks and Opportunities

Risks

• Patent expiries lead to significant generic competition.
• Regulatory shifts could restrict usage or impose new safety standards.
• Market penetration challenges in emerging economies due to cost constraints.

Opportunities

• New indications for hepatic or extr hepatic imaging.
• Developing second-generation contrast agents offering improved safety and efficacy.
• Partnerships with emerging market distributors to expand access.

Summary

Gadoxetate disodium remains a profitable niche within the MRI contrast agent market. Its usage is stable due to clinical preference for hepatocyte-specific imaging, especially for liver cancers. However, approaching patent expiration and generic competition create headwinds for revenue growth. Future performance hinges on patent litigation outcomes, pipeline innovation, and region-specific adoption.

Key Takeaways

• The global market for gadoxetate disodium was valued at approximately $275 million in 2022.
• Revenue growth prospects are modest (~2% CAGR), constrained by patent expiries and generic competition.
• Price sensitivity and reimbursement policies significantly influence profitability.
• Patent expiries in Europe and potential patent challenges in the U.S. could accelerate generic entry.
• Future growth opportunities depend on pipeline innovation and expansion into emerging markets.

FAQs

1. When will patents for gadoxetate disodium expire?
European patents expired in 2017; U.S. patents may have expired or face legal challenges, enabling generic entry since late 2010s.

2. How does gadoxetate disodium compare to other MRI contrast agents?
It offers hepatocyte-specific imaging, providing superior liver detail, particularly for HCC detection, but faces competition from agents with similar or broader indications.

3. What are major regulatory hurdles affecting its market?
Regulatory agencies require ongoing safety data, especially concerning gadolinium retention and rare adverse events, which can impact approval and labeling.

4. What are main factors influencing pricing in different markets?
Regulatory reimbursement policies, patent status, market competition, and healthcare infrastructure determine pricing.

5. Are there any emerging competitors or pipeline products?
Limited direct replacements are in development, with research focused on agents with improved safety profiles or broader indications. No major pipeline products threaten gadoxetate disodium’s niche presently.

---

References

1. MarketLine. (2022). MRI contrast agents market report.
2. Bayer. (2022). Eovist product information and sales data.
3. GlobalData. (2023). MRI contrast agent market forecast.
4. FDA. (2022). Approved drugs and biosimilars list.
5. European Medicines Agency. (2021). Summary of product characteristics for gadoxetate disodium.