CARDIOLITE Drug Patent Profile

Which patents cover Cardiolite, and what generic alternatives are available?

Cardiolite is a drug marketed by Lantheus Medcl and is included in one NDA.

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

Summary for CARDIOLITE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	10
Patent Applications:	11
Drug Prices:	Drug price information for CARDIOLITE
What excipients (inactive ingredients) are in CARDIOLITE?	CARDIOLITE excipients list
DailyMed Link:	CARDIOLITE at DailyMed

See drug prices for CARDIOLITE

Recent Clinical Trials for CARDIOLITE

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

Sponsor	Phase
GE Healthcare	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CARDIOLITE clinical trials

US Patents and Regulatory Information for CARDIOLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	AP	RX	Yes	Yes

Expired US Patents for CARDIOLITE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990

International Patents for CARDIOLITE

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

Country	Patent Number	Title	Estimated Expiration
Norway	172693
Norway	166640
Mexico	9203600	ADUCTOS DE TRIS(ISONITRILO)COBRE(I) PARA PREPARAR COMPLEJOS DE RADIONUCLIDOS.
Spain	2036171

Supplementary Protection Certificates for CARDIOLITE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
0107734	SPC/GB93/166	United Kingdom		SPC/GB93/166, EXPIRES: 20050816

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CARDIOLITE

Last updated: July 30, 2025

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Introduction

CARDIOLITE, a pharmaceutical drug primarily used in cardiac imaging, represents a significant asset within the cardiology diagnostic niche. Approved for detecting myocardial perfusion abnormalities, CARDIOLITE's market positioning hinges on technological advancements, regulatory pathways, and competitive landscapes. As healthcare systems evolve with increased emphasis on non-invasive diagnostics, understanding the market dynamics and financial prospects for CARDIOLITE informs stakeholders about its growth potential and investment viability.

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Product Overview and Clinical Significance

CARDIOLITE's core value proposition lies in its ability to facilitate highly accurate myocardial perfusion imaging (MPI), essential for diagnosing ischemic heart disease — a global health burden responsible for approximately 16% of deaths worldwide (WHO, 2017). Its active ingredient, technetium-99m sestamibi, has become a standard in nuclear cardiology due to its favorable properties, including high liver clearance and myocardial retention.

The drug's clinical utility is reinforced by its non-invasive nature, allowing practitioners to assess coronary blood flow and myocardial viability without the risks associated with invasive catheterization. The expanding adoption of gamma cameras and SPECT (Single Photon Emission Computed Tomography) technologies further propels demand for reliable radiopharmaceuticals like CARDIOLITE.

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Market Drivers

1. Rising Global Cardiovascular Disease (CVD) Prevalence

The escalating incidence of CVD directly propels demand for effective diagnostic tools. The Global Burden of Disease report (2019) estimates that ischemic heart disease causes over 8.9 million deaths annually. As populations age, especially in developed economies, the need for precise, non-invasive diagnostic imaging increases, benefiting products like CARDIOLITE.

2. Advancements in Nuclear Imaging Technologies

Innovations in gamma camera sensitivity, SPECT/CT hybrid devices, and software enhancements augment the diagnostic accuracy and workflow efficiency of nuclear cardiology. These technological improvements expand the market for radiopharmaceuticals, including CARDIOLITE.

3. Regulatory Approvals and Reimbursement Policies

Regulatory stability benefits product lifecycle. In the U.S., the Food and Drug Administration (FDA) has historically approved CARDIOLITE, ensuring its acceptance within clinical practice. Reimbursement policies in key markets like the U.S. and Europe influence adoption rates; favorable coverage enhances the drug’s financial prospects.

4. Aging Demographics

Globally, aging populations heighten the prevalence of cardiac conditions, increasing diagnostic procedures such as MPI. This demographic shift is especially prominent in developed nations, where healthcare systems prioritize non-invasive diagnostics.

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Competitive Landscape

CARDIOLITE faces competition from alternative radiotracers and imaging modalities:

• Technetium-99m Tetrofosmin: Similar efficacy, with distinct pharmacokinetic profiles.
• Myocardial PET Agents (Rubidium-82, N13 ammonia): Offer improved spatial resolution but are limited by higher costs and infrastructure needs.
• Non-nuclear modalities (CTA, MRI): Non-invasive, but often more expensive and less accessible.

Market leaders such as GE Healthcare, Siemens (via isotopes supplier Mallinckrodt), and Jubilant Radiopharma dominate the supply chain. The emerging role of PET imaging and hybrid modalities could influence the future demand dynamics for CARDIOLITE.

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Regulatory and Market Access Challenges

The replacement of older radiotracers with newer alternatives poses a threat to CARDIOLITE's market share. Competitive regulatory processes, particularly for novel tracers, can influence market entry or expansion. Cost-effectiveness evaluations by healthcare payers also influence adoption, especially as newer, potentially superior tracers enter the market.

In some regions, regulatory offtake criteria favor local manufacturing or specific pricing policies, which can impact revenue streams. Additionally, the global supply chain for technetium-99m remains vulnerable to disruptions, influencing availability and pricing.

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Financial Trajectory Analysis

1. Revenue Generation and Market Penetration

Current revenues for CARDIOLITE are driven by annual diagnostic procedures estimated between 2-3 million globally, with the U.S. accounting for a significant proportion due to higher healthcare spending and established nuclear cardiology practices. Average pricing varies, but in the U.S., the cost per dose ranges from $300 to $500.

Market penetration is steady but constrained by competitive dynamics and limited adoption of SPECT technology in emerging markets, where resource limitations restrict procedural capacity. Expansion depends on bolstering distribution networks, clinician education, and demonstrating cost-effectiveness compared to emerging modalities.

2. Pricing Trends and Reimbursement Landscape

Reimbursement policies significantly influence NAV (net annual value). Recent shifts towards value-based care in major markets focus on diagnostic accuracy, cost savings from early intervention, and patient outcomes. Radiopharmaceutical manufacturers like Jubilant Radiopharma have negotiated favorable reimbursement rates, buffering revenue streams.

3. Patent and Regulatory Lifecycle

The original patent for CARDIOLITE expired in 2012 in the U.S. and Europe, opening avenues for generics and biosimilars. While regulatory exclusivity extends due to data protections, the presence of generic competitors introduces price competition, potentially reducing profit margins.

4. Future Revenue Outlook

Market forecasts predict a compound annual growth rate (CAGR) of approximately 3-4% for nuclear cardiology radiopharmaceuticals over the next five years, driven by increasing CVD burden and technological integration. For CARDIOLITE specifically, growth is contingent upon maintaining market share against newer agents and expanding into emerging markets through strategic partnerships.

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Strategic Opportunities and Challenges

Opportunities:

• Technological Integration: Partnering with imaging device manufacturers to embed or streamline CARDIOLITE workflows.
• Emerging Markets: Expanding presence in Asia-Pacific, Latin America, and Africa, where cardiovascular diagnostics are underutilized.
• Innovative Formulations: Developing long shelf-life or easier-to-administer formulations to increase usability.

Challenges:

• Pipeline Competition: Development of PET-based cardiac agents with superior imaging qualities.
• Supply Chain Vulnerability: Dependence on technetium-99m production, which can be affected by reactor outages.
• Regulatory Barriers: Navigating complex approval processes, especially in expanding markets.

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Conclusion and Outlook

The financial trajectory of CARDIOLITE hinges on a confluence of market drivers—including rising CVD prevalence, technological innovations, and demographic shifts—and competitive and regulatory challenges. While the product's current revenue profile remains robust within established markets, future growth demand strategic maneuvering—especially in embracing technological advancements, expanding geographic reach, and navigating generics' entry.

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Key Takeaways

• Market Growth is Driven by Global CVD Burden and Technological Advancements: Rising cardiovascular disease rates and innovations in imaging technology support steady demand for CARDIOLITE.
• Competitive Pressures and Patent Expiry Influence Profitability: Patent expirations and competition from alternative tracers necessitate strategic differentiation and cost efficiency.
• Emerging Markets Offer Significant Expansion Opportunities: Tailored strategies could enable market penetration in regions with increasing healthcare infrastructure investments.
• Reimbursement and Policy Environment Are Critical: Favorable reimbursement policies bolster revenue, while policy shifts towards newer imaging modalities could pose risks.
• Supply Chain Stability Is Essential: Dependence on technetium-99m production requires resilience strategies to mitigate potential disruptions.

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FAQs

1. What is the primary clinical use of CARDIOLITE?
CARDIOLITE is used in myocardial perfusion imaging (MPI) to diagnose ischemic heart disease, enabling clinicians to assess coronary blood flow non-invasively.

2. How does the competitive landscape affect CARDIOLITE’s market share?
Competition from other radiotracers, PET agents, and emerging imaging modalities can limit CARDIOLITE’s market share, especially as newer, potentially more precise agents gain regulatory approval.

3. What are the main regulatory considerations impacting CARDIOLITE?
Patent expirations and approval processes for generic versions influence pricing and profitability, while supply chain dependencies on technetium-99m pose logistical challenges.

4. Which regions present the most growth potential for CARDIOLITE?
Emerging markets in Asia-Pacific, Latin America, and Africa offer substantial opportunities due to increasing healthcare investments and rising CVD prevalence.

5. How do technological advances in imaging impact CARDIOLITE’s future prospects?
Advances like hybrid SPECT/CT and PET imaging can either complement or compete with CARDIOLITE, requiring strategic adaptation to maintain relevance.

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References

[1] World Health Organization. (2017). Cardiovascular diseases (CVDs).
[2] Global Burden of Disease Study. (2019). Global cardiovascular disease statistics.
[3] GE Healthcare. (2022). Cardiology Portfolio and Market Outlook.
[4] Jubilant Radiopharma. (2021). Market Analysis of Nuclear Cardiology Agents.
[5] U.S. Food and Drug Administration. (2012). FDA Approvals for Nuclear Imaging Agents.