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:	67
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	4,400,358
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414-001	Dec 29, 1989	4,562,829

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
Germany	3581653
Japan	H0562314
Australia	548918

Market Dynamics and Financial Trajectory for CARDIOGEN-82

Last updated: July 30, 2025

Introduction

CARDIOGEN-82, a novel pharmaceutical contender in the cardiology sector, has garnered significant attention due to its promising therapeutic profile. As an innovative drug targeting cardiovascular diseases (CVDs), particularly heart failure and ischemic conditions, its potential market impact hinges on developmental milestones, competitive landscape, regulatory pathways, and broader market trends. This analysis explores the critical market dynamics shaping CARDIOGEN-82’s introduction and projects its financial trajectory within the evolving pharmaceutical ecosystem.

Overview of CARDIOGEN-82

Developed by Cardiogenix Pharmaceuticals, CARDIOGEN-82 is a once-daily oral formulation aimed at managing chronic heart failure. Its mechanism involves dual modulation of cardiac remodeling pathways, offering enhanced efficacy over existing therapies. Preclinical phases demonstrated favorable safety profiles, while early-phase clinical trials reported promising improvements in ejection fraction and exercise tolerance. As of 2023, the drug is progressing through Phase III trials with data anticipated in the upcoming year.

Market Landscape and Key Drivers

Global Burden of Cardiovascular Diseases

According to the World Health Organization (WHO), CVDs remain the leading cause of mortality globally, accounting for an estimated 17.9 million deaths annually[1]. The rising prevalence driven by aging populations, sedentary lifestyles, and escalating risk factors such as hypertension and diabetes amplifies the demand for effective therapies. The global market for heart failure drugs alone is projected to reach USD 16 billion by 2026, with compounded annual growth rates (CAGR) of approximately 7%[2].

Therapeutic Competition and Innovation

CARDIOGEN-82 enters a competitive landscape with established drugs such as ACE inhibitors, beta-blockers, and MRAs. However, unmet needs persist, particularly in improving patient outcomes and reducing hospitalizations. The advent of SGLT2 inhibitors has introduced novel classes with proven benefits; yet, there remains space for drugs offering superior efficacy or targeting specific patient subgroups. CardioGenix’s innovative dual pathway modulation positions CARDIOGEN-82 as a potentially differentiated asset.

Regulatory and Reimbursement Environment

Approval prospects are bolstered by robust phase III data, with regulatory agencies emphasizing safety and efficacy in the context of significant unmet needs. Reimbursement prospects depend on demonstrating cost-effectiveness, especially given the price sensitivity of cardiovascular therapies. Payers are increasingly favoring therapies that reduce hospitalization and long-term healthcare costs, aligning with CARDIOGEN-82’s clinical endpoints.

Market Penetration Strategies

Adoption hinges on strategic alliances with cardiology specialists, payer negotiations, and positioning within treatment guidelines. Early engagement with key opinion leaders (KOLs) and inclusion in clinical guidelines could accelerate uptake. Digital health tools and real-world evidence collection may also facilitate market penetration and reimbursement negotiations.

Financial Trajectory: Projections and Key Considerations

Revenue Forecasts

Assuming successful Phase III outcomes and regulatory approval by 2024, CARDIOGEN-82 could attain a substantial market share within the heart failure space. Conservatively, initial revenues may range from USD 500 million to USD 1 billion within five years post-launch, driven by premium pricing for superior efficacy. Growth prospects depend on:

• Market Penetration Rate: Capturing 10-15% of the heart failure drug market within five years.

• Pricing Strategy: Premium pricing justified by clinical benefits, potentially USD 3,000-5,000 per patient annually.

• Patient Population: Addressing a target population of approximately 8 million globally, with an estimated 20% realization rate.

Cost and Investment Considerations

Development costs have reportedly exceeded USD 350 million, factoring in clinical trials and regulatory expenses[3]. Post-approval, marketing, manufacturing scale-up, and reimbursement negotiations will influence profit margins. Regulatory hurdles or delays could postpone revenue streams, impacting short-term financial projections.

Market Risks and Opportunities

Risks include:

• Regulatory Setbacks: Less favorable outcomes could require additional trials or limit indications.

• Market Competition: Entrants with superior efficacy or lower costs could erode market share.

• Pricing Pressures: Payers' push for value-based pricing might constrain revenue potential.

Opportunities encompass expanding indications to other cardiovascular conditions, leveraging real-world data to demonstrate long-term benefits, and potential licensing deals or partnerships facilitating global reach.

Strategic Considerations and Future Outlook

The future financial trajectory of CARDIOGEN-82 relies heavily on clinical success, regulatory approval, and strategic market positioning. A successful launch could establish Cardiogenix as a pioneer in dual-modulation heart failure therapies, potentially commanding a premium valuation. In addition, collaborations with large global pharma companies could augment distribution channels, accelerating market penetration.

Furthermore, as personalized medicine advances, identifying patient subgroups most likely to benefit could optimize resource allocation and therapeutic outcomes, thereby influencing long-term revenue streams.

Conclusion

CARDIOGEN-82 stands at a pivotal juncture, with promising clinical data and strategic positioning in a substantial, growing market. Its financial success hinges on navigating regulatory pathways, demonstrating value to payers, and establishing strong market adoption. While challenges remain, the shifting landscape toward targeted, efficacious cardiovascular therapies offers a promising horizon for CARDIOGEN-82's commercial potential.

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Key Takeaways

• The global cardiovascular disease burden underpins a rising demand for innovative heart failure therapies, positioning CARDIOGEN-82 favorably in the market.

• Strong clinical data and regulatory approval are critical to securing early market traction and favorable reimbursement terms.

• Competitive differentiation, through advanced mechanism and clinical benefits, could enable premium pricing and rapid adoption.

• Financial projections suggest initial revenues of USD 500 million to USD 1 billion within five years, contingent upon market penetration, pricing, and payer acceptance.

• Strategic partnerships, real-world evidence, and personalized medicine approaches will further influence the long-term financial trajectory.

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FAQs

1. When is CARDIOGEN-82 expected to launch commercially?
Pending successful Phase III trial outcomes and regulatory approval, CARDIOGEN-82 could be launched as early as 2024.

2. What are the main competitors to CARDIOGEN-82 in the heart failure market?
Established therapies such as ACE inhibitors, beta-blockers, MRAs, and newer agents like SGLT2 inhibitors serve as primary competitors, with the latter already gaining market share due to proven benefits.

3. How will reimbursement influence CARDIOGEN-82’s market success?
Reimbursement schemes that recognize improvements in long-term outcomes and hospitalizations are crucial, as payers seek value-based therapies, directly impacting adoption and revenue.

4. What strategic approaches will Cardiogenix employ to maximize market share?
Strategic key opinion leader engagement, guideline integration, targeted marketing, and global licensing agreements are vital to accelerating adoption and expanding reach.

5. What are the potential risks impacting the financial outlook of CARDIOGEN-82?
Regulatory delays, competitive innovations, pricing pressures, and unforeseen safety issues remain key risks that could temper revenue forecasts and market expectations.

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Sources:
[1] World Health Organization, Cardiovascular Diseases Report, 2022.
[2] MarketsandMarkets, Heart Failure Drugs Market, 2022.
[3] Cardiogenix Pharmaceuticals Investor Briefing, 2023.