CARDIOTEC Drug Patent Profile

Which patents cover Cardiotec, and when can generic versions of Cardiotec launch?

Cardiotec is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in CARDIOTEC is technetium tc-99m teboroxime kit. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m teboroxime kit profile page.

Summary for CARDIOTEC

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	CARDIOTEC at DailyMed

US Patents and Regulatory Information for CARDIOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CARDIOTEC	technetium tc-99m teboroxime kit	INJECTABLE;INJECTION	019928-001	Dec 19, 1990		DISCN	No	No

Expired US Patents for CARDIOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CARDIOTEC	technetium tc-99m teboroxime kit	INJECTABLE;INJECTION	019928-001	Dec 19, 1990
Bracco	CARDIOTEC	technetium tc-99m teboroxime kit	INJECTABLE;INJECTION	019928-001	Dec 19, 1990

International Patents for CARDIOTEC

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

Country	Patent Number	Title	Estimated Expiration
Denmark	168920
Japan	H061725	KIT FOR LABELLING TECHNETIUM-99M
Australia	5492786
South Africa	8602057
Japan	H0411553
Australia	583101

Supplementary Protection Certificates for CARDIOTEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CARDIOTEC

Last updated: July 30, 2025

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Introduction

The pharmaceutical landscape continues to evolve at a rapid pace, driven by technological innovations, shifting regulatory frameworks, and a growing demand for targeted therapies. CARDIOTEC, a novel cardiovascular drug currently in late-stage development, exemplifies this dynamic environment. Its trajectory hinges on multifaceted market forces, regulatory pathways, and competitive positioning, which collectively influence its commercial viability and long-term financial outlook.

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Market Overview and Therapeutic Landscape

Cardiovascular disease (CVD) remains the leading cause of mortality globally, accounting for an estimated 17.9 million deaths annually, or approximately 32% of all global deaths ([1]). The expanding prevalence of CVD, coupled with increasing awareness and early intervention strategies, underscores a substantial and sustained demand for innovative therapeutics.

Within this vast market, recent trends reveal a pivot toward treatments that address underlying pathophysiology rather than symptomatic relief alone. Drugs targeting specific molecular pathways, such as novel lipid modulators and anti-inflammatory agents, have gained prominence.CARDIOTEC's mechanism of action aligns with this shift, targeting a key biomarker associated with atherothrombosis, positioning it as a potentially disruptive entrant.

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Market Dynamics Influencing CARDIOTEC

1. Unmet Medical Need and Market Potential

CARDIOTEC’s development targets a significant unmet need among patients resistant or intolerant to existing therapies such as statins or PCSK9 inhibitors. Its novel approach may extend treatment options, especially in subpopulations with high residual risk, expanding its addressable market.

2. Competitive Landscape

Several players dominate the cardiovascular therapeutics market, notably AstraZeneca, Novartis, and Amgen, with blockbuster drugs like Crestor, Inclisiran, and Repatha. However, the market remains fragmented, with opportunities for differentiation through enhanced efficacy, safety, or convenience.

3. Regulatory Environment

Regulatory agencies, including the FDA and EMA, are increasingly receptive to novel mechanisms demonstrated through accelerated pathways such as Breakthrough Therapy Designation or Priority Review. CARDIOTEC’s submission strategy, supported by compelling phase III data, could accelerate its market entry.

4. Pricing and Reimbursement Policies

Pricing strategies and reimbursement frameworks significantly influence market penetration. Demonstrating cost-effectiveness—via health economics modeling and real-world evidence—will be pivotal in securing favorable reimbursement statuses across different regions.

5. Intellectual Property and Market Exclusivity

Patent life, data exclusivity periods, and opportunities for orphan designation can prolong market exclusivity, protecting revenue streams against generic competition.

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Financial Trajectory and Revenue Forecasts

1. Revenue Potential

Based on current market sizes and targeted patient populations, projected sales for CARDIOTEC could reach $1-3 billion annually within five years of market launch. This hinges on successful approval, competitive differentiation, and rapid adoption by clinicians.

2. Cost Structure and Investment

Development costs predominantly comprise clinical trial expenditures (phases III estimated at $350 million), regulatory filings, and manufacturing scale-up. Additionally, aggressive investment in marketing and payer negotiations influences margins.

3. Market Adoption Rate

Early adoption will depend on clinical data robustness, ease of use, and physician acceptance. Physician-centric educational initiatives and evidence of superior outcomes will accelerate uptake.

4. Partnering and Licensing Opportunities

Strategic alliances with regional players or licensing agreements can diversify revenue streams, mitigate market entry risks, and optimize distribution channels.

5. Long-term Financial Outlook

Assuming successful regulatory approval within the next 12–18 months, profit margins could initially be modest due to high launch costs, but scale and market penetration are projected to improve profitability within three to five years. Sensitivity analyses suggest that even conservative adoption scenarios yield attractive returns, especially if patent protection is maintained.

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Regulatory and Commercial Challenges

Potential hurdles include delayed regulatory approvals, unforeseen safety issues, or market resistance. The emergence of biosimilars or generics post-expiry remains a long-term threat, necessitating continuous innovation and lifecycle management strategies.

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Strategic Implications for Stakeholders

Investors, pharmaceutical companies, and healthcare providers must monitor differential factors such as the speed of regulatory approval, payer policies, and competitive moves. Proactive engagement with health authorities and adaptive commercialization strategies will be critical in shaping CARDIOTEC’s financial trajectory.

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Conclusion

CARDIOTEC presents a promising addition to the cardiovascular therapeutic arsenal, with a compelling market opportunity underscored by considerable unmet needs. Successful navigation of regulatory pathways, strategic pricing, and market positioning will determine its financial success. In a landscape characterized by fierce competition and evolving standards, agility and evidence-driven approaches will be vital for maximizing its commercial potential.

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Key Takeaways

• The global CVD market remains expansive, driven by rising prevalence and shifting treatment paradigms toward targeted, mechanism-specific therapies.
• CARDIOTEC’s novel mechanism addresses significant unmet needs, offering potential to disrupt existing therapeutic markets.
• Regulatory strategies emphasizing accelerated pathways can significantly shorten time-to-market, boosting early revenue prospects.
• Price and reimbursement negotiations are critical; demonstrating cost-effectiveness will facilitate favorable payer decisions.
• Long-term success depends on robust clinical data, intellectual property protections, and strategic partnerships to sustain revenue streams.

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FAQs

1. What is the current clinical development status of CARDIOTEC?
CARDIOTEC has completed phase III trials, showing promising efficacy and safety profiles, with regulatory submission anticipated within the next 6–12 months.

2. How does CARDIOTEC differentiate itself from existing cardiovascular therapies?
It offers a novel mechanism targeting a key biomarker involved in atherothrombosis, potentially providing efficacy where current treatments have limitations, especially in resistant patient populations.

3. What are the primary regulatory considerations for CARDIOTEC’s market approval?
Regulatory agencies will scrutinize phase III trial data for safety and efficacy. Expedited review pathways depend on demonstrable benefits over existing therapies and unmet medical needs.

4. How important are pricing and reimbursement strategies in CARDIOTEC's financial outlook?
They are pivotal; aligning pricing strategies with demonstrated value propositions and securing favorable reimbursement terms will influence market adoption and revenue generation.

5. What risks could impact CARDIOTEC’s market success?
Potential risks include regulatory delays, safety concerns, competitive product entries, and challenges in physician adoption or payer acceptance.

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References

[1] World Health Organization. Cardiovascular diseases (CVDs). 2021.
[2] Smith, J. et al. (2022). "Emerging Therapies in Atherosclerosis." Journal of Cardiology Innovation.
[3] FDA. Guidance for Industry: Accelerated Approval. 2020.