Gadopiclenol - Generic Drug Details

What are the generic sources for gadopiclenol and what is the scope of patent protection?

Gadopiclenol is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gadopiclenol has ninety-seven patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Summary for gadopiclenol

International Patents:	97
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	11
Patent Applications:	3
What excipients (inactive ingredients) are in gadopiclenol?	gadopiclenol excipients list
DailyMed Link:	gadopiclenol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gadopiclenol

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gadopiclenol

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

Sponsor	Phase
Johns Hopkins University	Phase 4
Guerbet	Phase 4
Guerbet	Phase 3

See all gadopiclenol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gadopiclenol

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

US Patents and Regulatory Information for gadopiclenol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-002	Sep 21, 2022		RX	Yes	Yes	11,590,246		Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-005	Sep 21, 2022		RX	Yes	Yes	10,973,934			Y
Guerbet	ELUCIREM	gadopiclenol	SOLUTION;INTRAVENOUS	216986-006	Sep 21, 2022		RX	Yes	Yes

International Patents for gadopiclenol

Country	Patent Number	Title	Estimated Expiration
Croatia	P20221402
Japan	2022009463	ジアステレオ異性的に濃縮されたＰＣＴＡから誘導されたガドリニウム及びキレート配位子の錯体並びに調製及び精製プロセス
Serbia	64334	KOMPLEKS GADOLINIJUMA I HELIRAJUĆEG LIGANDA DOBIJENOG OD DIJASTEREOIZOMERNO OBOGAĆENOG PCTA I POSTUPAK ZA PRIPREMU I PREČIŠĆAVANJE (COMPLEX OF GADOLINIUM AND A CHELATING LIGAND DERIVED FROM DIASTEREOISOMERICALLY ENRICHED PCTA AND METHOD FOR PREPARING AND PURIFYING SAME)

Supplementary Protection Certificates for gadopiclenol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1931673	C01931673/01	Switzerland		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69037 21.12.2023
1931673	7/2024	Austria		PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 (MITTEILUNG) 20231208
1931673	C202430008	Spain		PRODUCT NAME: GADOPICLENOL; NATIONAL AUTHORISATION NUMBER: EU/1/23/1772; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1772; DATE OF FIRST AUTHORISATION IN EEA: 20231207

Market Dynamics and Financial Trajectory for Gadopiclenol

Introduction to Gadopiclenol

Gadopiclenol, a novel macrocyclic gadolinium-based contrast agent (GBCA), has recently gained significant attention in the medical imaging sector. Approved by the U.S. Food and Drug Administration (FDA) in September 2022, gadopiclenol is marketed under the brand name VUEWAY by Bracco and as Elucirem by Guerbet[3][4][5].

Market Growth Drivers

Advancements in Imaging Technology

The contrast media market, including gadopiclenol, is driven by advancements in medical imaging technology. As imaging techniques become more sophisticated, the demand for high-quality contrast agents increases. Gadopiclenol, with its high relaxivity and stability, is well-positioned to capitalize on these advancements[1][4].

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as cardiovascular conditions and cancer has led to an increased need for diagnostic imaging tests, including MRI and CT scans. This trend is expected to continue, driving the demand for contrast agents like gadopiclenol[4].

Strategic Collaborations and Growth Strategies

Companies like Bracco and Guerbet are engaging in strategic collaborations to enhance their market presence. For instance, Bracco Imaging and Guerbet have a worldwide strategic collaboration for the development and marketing of gadopiclenol. Such collaborations are crucial for expanding product offerings and gaining regulatory approvals in various markets[1][4].

Market Size and Forecast

Contrast Media Market

The global contrast media market was valued at USD 6.28 billion in 2023 and is expected to grow at a CAGR of 7.98% from 2024 to 2030. This growth is attributed to the increasing demand for diagnostic imaging and the expansion of applications for contrast agents[4].

High Pressure Contrast Media Injectors Market

The global high-pressure contrast media injectors market, closely related to the use of gadopiclenol, was valued at USD 243.87 million in 2023 and is expected to reach USD 371.61 million by 2029, growing at a CAGR of 7.23% during the forecast period. This growth is driven by the need for advanced imaging techniques and the increasing prevalence of chronic diseases[3].

Financial Trajectory

Revenue Projections

Given the approval and launch of gadopiclenol, the financial trajectory for this product is promising. With a growing market size for contrast media and high-pressure injectors, companies like Bracco and Guerbet are expected to see significant revenue growth. The strategic collaborations and aggressive marketing strategies will further boost the financial performance of these companies[1][3][4].

Investment in Healthcare Infrastructure

Increasing investments in healthcare infrastructure, particularly in emerging markets, are expected to drive the demand for advanced medical technologies, including contrast agents and injectors. This trend will contribute to the financial growth of companies involved in the production and distribution of gadopiclenol[3].

Key Challenges

High Costs of Advanced Devices

One of the primary challenges in the market is the high cost associated with advanced devices, including high-pressure contrast media injectors. This can be a deterrent for smaller healthcare providers and diagnostic centers, especially in developing regions, leading to disparities in the availability of quality imaging services[3].

Regulatory and Safety Considerations

Gadopiclenol, like other GBCAs, comes with regulatory and safety considerations. The product label includes a black box warning regarding the increased risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drug. However, studies have shown that macrocyclic GBCAs like gadopiclenol have a lower risk profile compared to linear GBCAs[5].

Regional Market Dynamics

North America and Europe

North America and Europe are significant markets for contrast media and high-pressure injectors. The approval of gadopiclenol in these regions has opened up new opportunities for Bracco and Guerbet. The presence of established healthcare infrastructure and the high prevalence of chronic diseases in these regions drive the demand for advanced imaging technologies[3][4].

Asia Pacific

The Asia Pacific region is expected to grow at the highest CAGR over the forecast period due to economic development and the presence of both local and foreign manufacturers. Countries like China and India are investing heavily in healthcare infrastructure, which will increase the demand for contrast agents and injectors[4].

Competitive Landscape

Key Players

The market for contrast media is highly competitive, with key players such as Bracco, Guerbet, and GE Healthcare. These companies are focusing on growth strategies including new product launches, regulatory approvals, expansions, collaborations, and acquisitions. For example, GE HealthCare introduced Pixxoscan (gadobutrol), another macrocyclic GBCA, which is expected to further compete in the market[1][4].

Key Takeaways

• Market Growth: The contrast media market, driven by advancements in imaging technology and increasing chronic disease prevalence, is expected to grow significantly.
• Financial Trajectory: Companies involved in the production and distribution of gadopiclenol are expected to see substantial revenue growth due to strategic collaborations and increasing demand.
• Challenges: High costs of advanced devices and regulatory considerations are key challenges in the market.
• Regional Dynamics: North America, Europe, and the Asia Pacific are crucial regions with varying growth dynamics.
• Competitive Landscape: The market is highly competitive with key players focusing on innovative products and strategic growth strategies.

FAQs

What is Gadopiclenol?

Gadopiclenol is a macrocyclic gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and other parts of the body[5].

Who are the key players in the market for Gadopiclenol?

Key players include Bracco, Guerbet, and GE Healthcare, which are involved in the production, distribution, and marketing of gadopiclenol and other contrast agents[1][4].

What are the main drivers of the contrast media market?

The main drivers include advancements in imaging technology, increasing prevalence of chronic diseases, and strategic collaborations among market players[1][3][4].

What are the challenges associated with the high-pressure contrast media injectors market?

High costs of advanced devices and ongoing maintenance costs are significant challenges, particularly for smaller healthcare providers in developing regions[3].

How does the regional market dynamics impact the demand for Gadopiclenol?

The demand for gadopiclenol varies by region, with North America and Europe being significant markets due to established healthcare infrastructure, and the Asia Pacific region showing high growth potential due to economic development and increasing healthcare investments[3][4].

Sources

1. Medi-Tech Insights: Contrast Media Market Outlook for 2024-2029.
2. Patsnap Synapse: Gadopiclenol - Drug Targets, Indications, Patents.
3. TechSci Research: High Pressure Contrast Media Injectors Market.
4. Grand View Research: Contrast Media Market Size & Share | Industry Report, 2030.
5. DrugBank: Gadopiclenol: Uses, Interactions, Mechanism of Action.

Last updated: 2024-12-16