ADENOSCAN Drug Patent Profile

When do Adenoscan patents expire, and when can generic versions of Adenoscan launch?

Adenoscan is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in ADENOSCAN is adenosine. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adenoscan

A generic version of ADENOSCAN was approved as adenosine by HIKMA on June 16^th, 2004.

Summary for ADENOSCAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	10
Patent Applications:	3,818
DailyMed Link:	ADENOSCAN at DailyMed

Recent Clinical Trials for ADENOSCAN

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

Sponsor	Phase
NYU Langone Health	N/A
University of Utah	Early Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1

See all ADENOSCAN clinical trials

Paragraph IV (Patent) Challenges for ADENOSCAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADENOSCAN	Injection	adenosine	3 mg/mL, 20 mL and 30 mL vials	020059	1	2005-04-18

US Patents and Regulatory Information for ADENOSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995		DISCN	Yes	No
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995		DISCN	Yes	No

Expired US Patents for ADENOSCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995	5,731,296
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,731,296

International Patents for ADENOSCAN

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

Country	Patent Number	Title	Estimated Expiration
Germany	3586993
European Patent Office	0506205	Utilisation de l'adénosine pour la fabrication d'un médicament pour l'injection intraveineuse en continu chez l'homme (Use of adenosine for the manufacture of medicaments for continuous intravenous infusion to human patients)
Canada	1301652	ADMINISTRATION INTRAVEINEUSE PROGRESSIVE DE L'ADENOSINE A DES SUJETS HUMAINS (CONTINUOUS INTRAVENOUS INFUSION OF ADENOSINE TO HUMAN PATIENTS)
Japan	2535504

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Adenoscan

Last updated: July 30, 2025

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Introduction

Adenoscan (adenosine) is a radiopharmaceutical agent primarily used in myocardial perfusion imaging (MPI) to assess coronary artery disease (CAD). It is administered intravenously to trigger coronary vasodilation, facilitating the visualization of blood flow within the heart muscle during nuclear stress tests. Since its approval, Adenoscan has played a crucial role in non-invasive cardiac diagnostics, underpinning a niche yet significant segment within the broader nuclear medicine market. This analysis explores the evolving market dynamics, competitive landscape, regulatory influences, and the financial trajectory shaping Adenoscan’s future.

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Market Overview and Key Drivers

Global Market Size and Growth Trends

The global nuclear medicine market, valued at approximately USD 7.9 billion in 2021, is projected to grow at a compound annual growth rate (CAGR) of about 3.9% through 2028 [1]. Within this, the cardiovascular diagnostic segment, encompassing MPI agents like Adenoscan, remains substantial owing to the increasing prevalence of CAD—a leading cause of mortality worldwide. The rise of non-invasive diagnostic techniques, including SPECT (Single Photon Emission Computed Tomography) imaging facilitated by agents like Adenoscan, fosters demand growth.

Demographic and Clinical Drivers

• Aging Population: An increasing aging demographic globally correlates with higher incidences of CAD. For example, the WHO estimates that over 85% of CAD deaths occur in low- and middle-income countries, fostering a rising demand for advanced diagnostic tools [2].

• Lifestyle Factors: Urbanization and sedentary lifestyles exacerbate CAD prevalence, encouraging clinicians to adopt reliable, rapid imaging agents like Adenoscan.

• Preventive Medicine and Efficiency: Enhanced diagnostic accuracy with Adenoscan (+Gated SPECT imaging) reduces unnecessary invasive procedures, aligning with healthcare systems’ shift toward value-based care.

Technological and Clinical Advances

Improvements in SPECT camera technology and hybrid imaging (SPECT/CT) elevate the diagnostic utility of Adenoscan, reinforcing its relevance. However, ongoing development of positron emission tomography (PET) agents, which offer superior resolution, could influence market share dynamics in the future.

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Competitive Landscape

Key Players and Market Share

While Adenoscan's primary producer is Eli Lilly and Company, other agents such as Regadenoson (Lexiscan), Dipyridamole, and newer PET tracers (e.g., Rubidium-82) collectively shape the competitive environment.

• Eli Lilly & Co.: Maintains a dominant position through its longstanding patent and widespread clinical adoption.
• Regadenoson (Lexiscan): Approved as a vasodilator agent with faster administration, it has gained market traction, challenging Adenoscan in some regions.
• Emerging Alternatives: The advent of PET-based tracers, driven by higher image resolution, threatens the traditional SPECT-based agents.

Patent and Regulatory Environment

Adenoscan lost its primary patent protection around 2010, leading to increased generic competition, which exerted downward pressure on prices and margins. Nonetheless, Eli Lilly continues to hold regulatory exclusivity in specific markets, leveraging branding and clinical familiarity.

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Regulatory and Reimbursement Landscape

Regulatory Approvals

Adenoscan’s approval status spans multiple regions, including FDA in the US, EMA in Europe, and PMDA in Japan. Regulatory constraints, especially related to safety concerns of adenosine (e.g., hypersensitivity, bronchospasm), necessitate careful clinical management.

Reimbursement Patterns

Coverage typically depends on country-specific health policies. In the US, Medicare and private insurers generally reimburse MPI procedures involving Adenoscan, though reimbursement rates fluctuate, impacting provider utilization volumes.

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Financial Trajectory and Revenue Outlook

Historical Financial Performance

Post-patent expiry, Adenoscan faced revenue decline due to generic competition and market saturation. Nonetheless, its role as a niche diagnostic agent ensures a baseline of steady demand, particularly in large, developed healthcare markets.

Revenue Projections

• Stability in Developed Markets: Anticipated to remain relatively stable due to established clinical adoption and ongoing demand in cardiology clinics.
• Growth in Emerging Markets: Expansion driven by increased healthcare infrastructure and CAD prevalence could moderately uplift revenues.
• Impact of Innovation: The rise of PET tracers might suppress traditional SPECT agents’ revenues, potentially leading to a decline over the next 5-7 years if newer technologies dominate.

Pricing Trends

Generic entry and increased competition softened pricing. Nevertheless, specialized clinical use and procedural consistency support margins within a narrow band. Reimbursement reforms and potential value-based pricing models could influence future pricing strategies.

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Market Entrants and Innovation Trajectories

Emerging technologies threaten Adenoscan's market position:

• PET-based Agents: Rubidium-82 and Nitrogen-13 tracers enable higher resolution imaging and quantification but require more sophisticated (and expensive) equipment.
• Adenosine Alternatives: Regadenoson (Lexiscan) offers simplified, rapid dosing with fewer contraindications, gaining favor among clinicians.

Regulatory pipeline developments aim at newer agents and protocols designed to enhance safety and diagnostic yield, potentially disrupting the existing Adenoscan-centric model.

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Risks and Challenges

• Safety Profile Concerns: Adenosine administration can induce side effects, necessitating trained personnel and limiting use in certain patient populations.
• Technological Shifts: Transition to PET and hybrid imaging platforms threaten the traditional SPECT-based agents.
• Market Saturation: Post-patent genericization constrains pricing power, impacting revenue growth.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investing in next-generation vasodilators or hybrid imaging agents may be vital to sustain relevance.
• Healthcare Providers: Marginal improvements in diagnostic accuracy and operational efficiencies influence volume and revenue.
• Investors: Stable cash flows from Adenoscan require balancing with the potential decline driven by technological obsolescence.

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Key Takeaways

1. Steady Demand in Established Markets: Adenoscan continues to serve a significant niche in myocardial perfusion imaging within mature healthcare systems, supported by prevalent CAD and established clinical protocols.

2. Competitive Threats from Advanced Imaging Modalities: The shift toward PET imaging agents and improved hybrid systems poses a risk of declining demand for SPECT-based agents like Adenoscan over the next decade.

3. Pricing and Reimbursement Influence Future Revenue: Patent expiry, generic competition, and health policy reforms exert downward pressure on margins, emphasizing the importance of innovation and market diversification.

4. Emerging Markets Offer Growth Opportunities: Increasing CAD burden and improving healthcare infrastructure in developing regions could transiently bolster Adenoscan revenues.

5. Innovation and Strategic Adaptation Are Crucial: Companies must invest in novel agents, enhance safety profiles, and optimize technology integration to sustain long-term viability.

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Frequently Asked Questions

1. What is the primary clinical indication for Adenoscan?
Adenoscan is primarily used in nuclear cardiology to perform myocardial perfusion imaging, helping diagnose coronary artery disease by assessing blood flow to the heart muscle during stress.

2. How does Adenoscan compare to alternative pharmacological stress agents?
Adenoscan (adenosine) offers effective vasodilation but has limitations including safety profile concerns. Regadenoson (Lexiscan) provides a faster, more convenient alternative with fewer contraindications, while dipyridamole is another vasodilator with similar applications.

3. What impact does patent expiration have on Adenoscan’s market?
Patent expiry around 2010 led to increased generic competition, resulting in pricing pressure and reduced revenues for branded Adenoscan. The market now favors cost-effective generics, impacting profit margins.

4. Is Adenoscan still relevant given technological advancements?
Yes, Adenoscan remains relevant in certain clinical settings and regions due to existing infrastructure and clinical familiarity. However, the growing adoption of PET imaging and newer agents may diminish its dominance over time.

5. What future strategies could sustain Adenoscan’s market position?
Innovating with safer formulations, integrating into hybrid imaging platforms, and expanding in emerging markets are key strategies. Additionally, developing next-generation vasodilators or tracers could secure continued relevance.

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References

1. Grand View Research, Nuclear Medicine Market Size & Trends, 2022.
2. World Health Organization, Cardiovascular Diseases Global Data, 2021.