CARDIOGEN-82 Drug Patent Profile

Which patents cover Cardiogen-82, and when can generic versions of Cardiogen-82 launch?

Cardiogen-82 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CARDIOGEN-82 is rubidium chloride rb-82. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rubidium chloride rb-82 profile page.

Summary for CARDIOGEN-82

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	32
What excipients (inactive ingredients) are in CARDIOGEN-82?	CARDIOGEN-82 excipients list
DailyMed Link:	CARDIOGEN-82 at DailyMed

Recent Clinical Trials for CARDIOGEN-82

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

Sponsor	Phase
Bracco Diagnostics, Inc

See all CARDIOGEN-82 clinical trials

Pharmacology for CARDIOGEN-82

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for CARDIOGEN-82

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989		RX	No	No

Expired US Patents for CARDIOGEN-82

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989

International Patents for CARDIOGEN-82

See the table below for patents covering CARDIOGEN-82 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0043650	METHOD AND ADSORBANT COMPOSITION FOR 82 RB GENERATION
South Africa	8103677
Canada	1233274	SYSTEME DE DOSIMETRIE POUR POMPE D'INFUSTION DE STRONTIUM-RUBIDIUM (DOSIMETRY SYSTEM FOR STRONTIUM-RUBIDIUM INFUSION PUMP)

CARDIOGEN-82 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDIOGEN-82

Introduction

CARDIOGEN-82, a rubidium Rb 82 chloride injection, is a critical diagnostic agent used in cardiac positron emission tomography (PET) myocardial perfusion imaging (MPI). This article delves into the market dynamics and financial trajectory of CARDIOGEN-82, highlighting its significance, challenges, and future prospects.

Market Size and Growth

The cardiac PET market, while growing, remains relatively small compared to other cardiac imaging modalities. As of recent data, the cardiac PET market in the U.S. is valued at approximately $80 million, which is a fraction of the larger cardiac SPECT market valued at $600-620 million[4].

Despite its niche size, the market shows potential for expansion. The introduction of new technologies and partnerships, such as those between Bracco Diagnostics and CardioNavix, aim to increase access to cardiac PET imaging, particularly in underserved markets[3].

Utilization and Adoption

Cardiac PET imaging still faces significant barriers to widespread adoption. It accounts for only about 2% of the volume of cardiac imaging procedures and around 5% of overall PET procedure volumes, which are largely dominated by FDG imaging in oncology[2].

The high costs associated with running a cardiac PET program, including the purchase of rubidium tracer generators and institutional cyclotrons, are major deterrents. These costs can exceed $400,000 per year, making it financially viable only for institutions with high patient volumes, such as large academic centers or cardiac centers of excellence[2].

Reimbursement and Financial Viability

Reimbursement for PET MPI has stabilized in recent years, with hospital settings receiving around $1,300 per procedure, including $250 for the radio-agent dose. However, this reimbursement rate is often insufficient to offset the high operational costs, making it challenging for many healthcare providers to break even without a high throughput of patients[2].

Technological Advancements and Innovations

Bracco Diagnostics has made significant investments in improving the technology behind CARDIOGEN-82. The new CardioGen-82 infusion system, approved by the FDA in 2020, is designed to enhance automation, efficiency, and simplicity in cardiac PET MPI. This system features intuitive and ergonomic details, reducing radiation exposure for staff and patients and providing easier access to system components[1][5].

Partnerships and Access Expansion

To increase patient access to cardiac PET imaging, Bracco Diagnostics has partnered with CardioNavix LLC. This partnership introduces the Bracco Mobile Isotope Service, an on-demand delivery program that reduces upfront costs and business risks for healthcare providers. CardioNavix's patented transport device allows for flexible use of the CardioGen-82 infusion system, even in facilities with lower patient volumes[3].

Competitive Landscape

The market for cardiac PET imaging agents is competitive, with other products like Ruby-Fill from Jubilant Life Sciences posing significant challenges. Ruby-Fill is noted for its material advantages over CARDIOGEN-82, although it is still in the early stages of market penetration due to existing contracts with Bracco Diagnostics[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of CARDIOGEN-82. FDA approvals are essential for the launch and continued use of these diagnostic agents. The recent approval of the new CardioGen-82 infusion system highlights Bracco Diagnostics' commitment to meeting regulatory standards and improving patient care[1][5].

Future Prospects

Despite the current challenges, the cardiac PET market is expected to grow as more healthcare providers adopt this advanced diagnostic modality. The expansion of patient access through innovative delivery programs and partnerships is likely to drive this growth. However, addressing the high costs and ensuring sufficient reimbursement will be critical for widespread adoption[3].

Key Takeaways

• Market Size: The cardiac PET market is valued at approximately $80 million in the U.S.
• Utilization: Cardiac PET accounts for only about 2% of cardiac imaging procedures.
• Financial Viability: High operational costs and insufficient reimbursement rates pose significant challenges.
• Technological Advancements: The new CardioGen-82 infusion system enhances automation and efficiency.
• Partnerships: Collaborations like the one with CardioNavix aim to increase patient access.
• Competitive Landscape: Other products like Ruby-Fill from Jubilant Life Sciences are gaining traction.

FAQs

What is CARDIOGEN-82 used for?

CARDIOGEN-82 is a radioactive diagnostic agent used for PET imaging of the myocardium to assess regional myocardial perfusion in adult patients suspected of having coronary artery disease[1][3].

What are the main challenges in adopting cardiac PET imaging?

The main challenges include high operational costs, insufficient reimbursement rates, and the need for high patient volumes to break even financially[2].

How does the new CardioGen-82 infusion system improve cardiac PET MPI?

The new system enhances automation, efficiency, and simplicity, with intuitive and ergonomic design, reducing radiation exposure and providing easier access to system components[1][5].

What is the significance of the partnership between Bracco Diagnostics and CardioNavix?

This partnership introduces the Bracco Mobile Isotope Service, an on-demand delivery program that reduces upfront costs and business risks, increasing patient access to cardiac PET imaging[3].

How does Ruby-Fill compare to CARDIOGEN-82?

Ruby-Fill from Jubilant Life Sciences is noted for its material advantages over CARDIOGEN-82, although it is still in the early stages of market penetration due to existing contracts with Bracco Diagnostics[4].

Sources

1. Bracco Diagnostics launches CardioGen-82 infusion system - Medical Device Network
2. Is Cardiac PET Finally Finding New Avenues for Growth? - Diagnostic Imaging
3. Bracco Diagnostics Inc. Announces New Partnership to Increase Access to Cardiac PET Imaging - PR Newswire
4. Jubilant Life Sciences - Nirmal Bang - Nirmal Bang Institutional Equities Research
5. Bracco Diagnostics Inc. Introduces New CardioGen-82® (Rubidium Rb 82 Generator) Infusion System - PR Newswire