EOVIST Drug Patent Profile

When do Eovist patents expire, and what generic alternatives are available?

Eovist is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in EOVIST is gadoxetate disodium. One supplier is listed for this compound. Additional details are available on the gadoxetate disodium profile page.

Summary for EOVIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	14
Drug Prices:	Drug price information for EOVIST
What excipients (inactive ingredients) are in EOVIST?	EOVIST excipients list
DailyMed Link:	EOVIST at DailyMed

See drug prices for EOVIST

Recent Clinical Trials for EOVIST

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 EOVIST clinical trials

Pharmacology for EOVIST

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

US Patents and Regulatory Information for EOVIST

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 EOVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	5,798,092
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	6,039,931
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-002	Feb 4, 2013	6,039,931

International Patents for EOVIST

See the table below for patents covering EOVIST around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2020142	COMPLEXES DE DTPA DERIVES (DERIVATIZED DTPA COMPLEXES)
Israel	94818	Derivatized diethylene triaminepentaacetic acid complexes and pharmaceutical and diagnostic compositions containing the same
Norway	902925
Japan	H03215457	DERIVED DTPA-COMPLEX, PHARMACEUTICAL PREPARATIONS CONTAINING SAME, NMR- AND ROENTGENDIAGNOSTIC AGENT AND RADIOTHERAPEUTIC AGENT CONTAINING SAID PREPARATIONS AND PREPARATION OF SAID COMPOUND AND PHARMACEUTICALS
New Zealand	234295	3,6,9-TRIAZA-3,6,9-TRIS(CARBOXYMETHYL)UNDECANEDIOIC ACID DERIVATIVES AND USE THEREOF IN RADIATION THERAPY AND DIAGNOSTIC IMAGING

Supplementary Protection Certificates for EOVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0405704	16/2005	Austria		PRODUCT NAME: GADOXETSAEURE DINATRIUM; NAT. REGISTRATION NO/DATE: 1-25757, 1-25758 20050302; FIRST REGISTRATION: SE 18929, 18930 20040326
0405704	C00405704/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
0405704	300182	Netherlands		300182, 20100627, EXPIRES: 20150626
0405704	SPC/GB05/021	United Kingdom		PRODUCT NAME: GADOXETIC ACID, OPTIONALLY IN THE FORM OF A SALT; REGISTERED: SE 18929 20040326; SE 18930 20040326; UK PL 00053/0348 20041110; UK PL 00053/0349 20041110
0405704	C300182	Netherlands		PRODUCT: GADOXETINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER HET NATRIUMZOUT. FIRST AUTHORIZATION NO/DATE: 1829 AND 18930, 20040326 (SE); NATIONAL AUTHORIZATION NO/DATE: RVG 31393 AND 31394, 20050113

Market Dynamics and Financial Trajectory for EOVIST

Introduction

EOVIST (gadolinium-EOB-DTPA) is a hepatobiliary specific contrast agent (HBA) approved by the FDA for MRI liver imaging. It is uniquely designed to provide both dynamic and functional information, making it a valuable tool in the diagnosis and characterization of focal liver diseases.

Market Position and Unique Selling Points

EOVIST is the only FDA-approved HBA for MR liver imaging, giving it a distinct market position. Its ability to combine dynamic phase imaging with hepatobiliary phase information allows for comprehensive evaluation of liver lesions, which is not possible with other gadolinium-based contrast agents[1][4].

Clinical Significance and Adoption

The clinical significance of EOVIST lies in its ability to enhance the signal intensity of normal liver parenchyma on T1-weighted images, thereby improving lesion-to-liver contrast. This is crucial for detecting and characterizing liver lesions, including malignant tumors that do not contain functioning hepatocytes. Clinical trials have demonstrated its safety and efficacy, with acceptable safety profiles and no significant adverse effects on vital signs or laboratory parameters[4].

Market Demand and Growth

The demand for liver-specific contrast agents like EOVIST is driven by the increasing need for accurate and non-invasive diagnostic tools in hepatology. The market for MRI contrast agents is growing, partly due to advancements in imaging technologies and the rising incidence of liver diseases. EOVIST's unique properties make it an attractive option for radiologists and clinicians, contributing to its market growth.

Financial Performance of the Manufacturer

Bayer, the manufacturer of EOVIST, does not release specific financial data for EOVIST alone. However, the overall financial performance of companies involved in the production and distribution of medical imaging agents can provide insights. For instance, Ecovyst, a company involved in various chemical and materials sectors, reports financial results that reflect broader market trends. While Ecovyst's financial reports do not directly relate to EOVIST, they indicate the economic stability and growth potential in related industries[2][5].

Revenue and Profitability

Although specific revenue figures for EOVIST are not publicly available, the overall sales and profitability of medical imaging agents can be inferred from broader industry trends. Companies like Ecovyst report significant revenues and adjusted EBITDA margins, indicating a stable financial foundation for the production and distribution of such agents. For example, Ecovyst reported sales of $691.1 million in 2023, with an Adjusted EBITDA margin of 30.7%, reflecting the financial health of the sector[5].

Safety and Efficacy Impact on Market

The safety and efficacy of EOVIST have been well-documented in clinical trials. With a low incidence of adverse reactions (predominantly mild to moderate) and no significant effects on vital signs or laboratory parameters, EOVIST has established a strong safety profile. This has contributed to its acceptance and adoption in clinical practice, positively impacting its market dynamics[1][4].

Competitive Landscape

The competitive landscape for liver-specific MRI contrast agents is relatively niche, with EOVIST and Resovist being two of the prominent agents. EOVIST's unique biphasic enhancement pattern and its ability to provide both dynamic and hepatobiliary phase information give it a competitive edge over other agents. The absence of accumulation phase imaging in other gadolinium-based contrast agents further solidifies EOVIST's market position[4].

Regulatory Environment

EOVIST has navigated the regulatory environment successfully, receiving FDA approval for its specific indication in MR liver imaging. Regulatory approvals and the inclusion in expedited access programs, as seen in other medical fields, can significantly influence market dynamics by ensuring quicker access to innovative diagnostic tools[3].

Future Outlook

The future outlook for EOVIST is promising, driven by the increasing demand for advanced diagnostic tools in hepatology. Advances in MRI technology and the expanding use of liver-specific contrast agents are expected to continue driving the market. Additionally, the growing incidence of liver diseases and the need for accurate, non-invasive diagnostic methods will likely sustain the demand for EOVIST.

Key Takeaways

• Unique Market Position: EOVIST is the only FDA-approved HBA for MR liver imaging.
• Clinical Significance: It provides both dynamic and hepatobiliary phase information, enhancing lesion-to-liver contrast.
• Safety and Efficacy: Demonstrated a strong safety profile with low incidence of adverse reactions.
• Market Demand: Driven by the need for accurate and non-invasive diagnostic tools in hepatology.
• Financial Performance: Part of a broader industry with stable financial foundations.
• Competitive Edge: Unique biphasic enhancement pattern sets it apart from other contrast agents.

FAQs

What is EOVIST used for?

EOVIST is used for intravenous administration in MRI of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

How does EOVIST work?

EOVIST is a hepatobiliary agent that is selectively taken up by hepatocytes, enhancing the signal intensity of normal liver parenchyma on T1-weighted images. It is excreted through both renal and biliary routes.

What are the common adverse reactions associated with EOVIST?

The most frequent adverse reactions include nausea, headache, feeling hot, dizziness, and back pain, which are predominantly mild to moderate in severity.

How long does an EOVIST MRI procedure take?

EOVIST imaging protocols allow for the collection of dynamic and functional information in under 30 minutes.

Is EOVIST safe for patients?

Clinical trials have shown that EOVIST has an acceptable safety profile with no significant effects on vital signs or laboratory parameters.

Sources

1. Radiology Global Master V1 - Eovist-injection | Radiology Global Master V1
2. Ecovyst Reports First Quarter 2024 Results - Ecovyst Reports First Quarter 2024 Results
3. Economics of new oncology drug development - PubMed
4. Eovist Injection and Resovist Injection: Two New Liver-Specific Contrast Agents for MRI - Cancer Network
5. Ecovyst Reports Fourth Quarter and Full Year 2023 Results - PR Newswire