GADOVERSETAMIDE - Generic Drug Details

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

Gadoversetamide is the generic ingredient in two branded drugs marketed by Liebel-flarsheim and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for gadoversetamide.

Summary for GADOVERSETAMIDE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	1,042
DailyMed Link:	GADOVERSETAMIDE at DailyMed

Recent Clinical Trials for GADOVERSETAMIDE

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

Sponsor	Phase
Daniel S. Berman	N/A
Astellas Pharma US, Inc.	N/A
Guerbet	Phase 4

See all GADOVERSETAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GADOVERSETAMIDE

V08CA	Paramagnetic contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for GADOVERSETAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-003	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999		DISCN	Yes	No
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999		DISCN	Yes	No

Expired US Patents for GADOVERSETAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999

EU/EMA Drug Approvals for GADOVERSETAMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mallinckrodt Deutschland GmbH	Optimark	gadoversetamide	EMEA/H/C/000745 This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.	Withdrawn	no	no	no	2007-07-23

GADOVERSETAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gadoversetamide

Market Overview

Gadoversetamide, a gadolinium-based contrast agent (GBCA), is an integral part of the broader contrast media market. This market is experiencing significant growth driven by several key factors.

Market Growth Drivers

Increasing Prevalence of Chronic Conditions

The rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders is driving the demand for diagnostic imaging procedures. This, in turn, increases the need for contrast agents like gadoversetamide[1].

Growing Number of Diagnostic Centers and Hospitals

The expansion of healthcare infrastructure, including the increasing number of hospitals and diagnostic imaging centers, is another significant driver. These facilities require a steady supply of contrast media to perform various imaging procedures[1].

Rising Volume of CT and MRI Examinations

The growing number of computed tomography (CT) and magnetic resonance imaging (MRI) examinations performed globally is a direct result of the increasing emphasis on early diagnosis and improved patient outcomes. Gadoversetamide, being an MRI contrast agent, benefits from this trend[2].

Market Restraints

Adverse Effects and Allergic Reactions

Despite the growing demand, the market for gadoversetamide and other contrast agents is restrained by the potential adverse effects and allergic reactions associated with their use. These include hypersensitivity reactions and the risk of nephrogenic systemic fibrosis (NSF) in patients with renal impairment[1][5].

Financial Trajectory

Current Market Size and Projection

The global contrast media market, which includes gadoversetamide, is projected to grow from $6.3 billion in 2023 to $9.7 billion by 2029, at a compound annual growth rate (CAGR) of 7.5%. The MRI contrast media market, a subset of this, is expected to grow from $1.48 billion in 2023 to $1.56 billion in 2024, with a CAGR of 6%[1][2].

Revenue Streams

The revenue for gadoversetamide and other MRI contrast agents is generated through the sale of these products to hospitals, diagnostic centers, and other healthcare facilities. The value includes related services sold by the manufacturers, such as training and support for the use of these agents[2].

Competitive Landscape

Key Players and Market Share

The market for gadoversetamide is competitive, with several key players including GE HealthCare, Guerbet, and Bracco Diagnostics. These companies are continuously expanding their portfolios and collaborating on research and development to stay ahead in the market. For instance, GE HealthCare introduced Pixxoscan (gadobutrol), a macrocyclic, non-ionic MRI GBCA, which competes directly with gadoversetamide[1].

Regional Market Dynamics

North America and Europe

These regions are significant markets for gadoversetamide due to their well-established healthcare systems and high demand for diagnostic imaging. The presence of major pharmaceutical companies and stringent regulatory frameworks also influence the market dynamics in these regions[1].

Asia Pacific

The Asia Pacific region, particularly countries like China, Japan, and India, is experiencing rapid growth in the contrast media market. This is driven by increasing investments in radiology, a growing incidence of chronic diseases, and expanding healthcare infrastructure[1].

Opportunities and Challenges

Opportunities

• Generic Contrast Media: The potential for generic versions of contrast agents could provide cost-effective alternatives and expand market access.
• Increasing Research: Ongoing research into safer and more effective contrast agents presents opportunities for innovation and market growth.
• Emerging Economies: Growing healthcare needs in emerging economies offer new market opportunities for gadoversetamide and other contrast agents[1].

Challenges

• Preference for Alternative Modalities: The preference for imaging modalities that do not require contrast media can reduce demand.
• Regulatory Restrictions: Restrictions on certain types of contrast agents, such as linear gadolinium-based agents, and product recalls can impact market growth.
• Shortage of Trained Professionals: A shortage of trained professionals in diagnostic imaging can limit the effective use of contrast agents like gadoversetamide[1].

Value Chain and Supply Chain Analysis

Manufacturing and Distribution

The value chain for gadoversetamide involves manufacturing, distribution, and sales. Companies like Bracco Diagnostics and Guerbet have collaborations for the production and research of contrast agents, ensuring a stable supply chain[1].

Regulatory Compliance

Compliance with regulatory requirements is crucial in the contrast media market. Recent approvals, such as the FDA approval for Gadopiclenol, highlight the importance of regulatory clearance in driving market growth[1].

Technological Advancements

Next-Generation Contrast Agents

Research into next-generation contrast agents, such as ferumoxytol-enhanced MRI, is ongoing. These advancements aim to provide safer and more effective imaging options, potentially impacting the market for traditional agents like gadoversetamide[4].

Key Takeaways

• The contrast media market, including gadoversetamide, is growing driven by increasing chronic disease prevalence and expanding healthcare infrastructure.
• The market faces restraints due to adverse effects and regulatory restrictions.
• The financial trajectory is positive, with significant growth projected over the next few years.
• Regional dynamics vary, with North America and Europe being key markets and Asia Pacific showing rapid growth.
• Opportunities exist in generic versions, increasing research, and emerging economies, but challenges include preference for alternative modalities and regulatory restrictions.

FAQs

1. What is the current market size of the global contrast media market?

The global contrast media market was valued at $6.3 billion in 2023[1].

2. What is the projected growth rate for the MRI contrast media market?

The MRI contrast media market is expected to grow at a CAGR of 6% from 2023 to 2024[2].

3. What are the main drivers of the contrast media market?

The main drivers include the rising prevalence of chronic diseases, growing number of diagnostic centers and hospitals, and increasing demand for early disease diagnosis[1].

4. What are the potential risks associated with gadoversetamide?

The potential risks include hypersensitivity reactions and the risk of nephrogenic systemic fibrosis (NSF) in patients with renal impairment[1][5].

5. Which regions are expected to drive the growth of the contrast media market?

North America, Europe, and the Asia Pacific region are expected to drive the growth of the contrast media market, with the Asia Pacific region showing particularly rapid growth[1].

Cited Sources:

1. MarketsandMarkets: Contrast Media Market Growth, Drivers, and Opportunities.
2. ResearchAndMarkets: MRI Contrast Media Global Market Report 2024.
3. FDA: 201277 Gadobutrol Clinical PREA.
4. Oxford Academic: Unveiling the next generation of MRI contrast agents: current trends and future directions.
5. FDA: N201-277S008 Gadobutrol Clinical PREA.