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
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995

International Patents for ADENOSCAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	5065585
Japan	2535504
Japan	H10114684	DIAGNOSING AUXILIARY USEFUL FOR DIAGNOSIS OF MYOCARDIAL FAILURE
Austria	84419
Japan	H0347136	AUXILIARIES FOR VASCULAR DIAGNOSIS
European Patent Office	0275249	CONTINUOUS INTRAVENOUS INFUSION OF ADENOSINE TO HUMAN PATIENTS, A UNIT DOSAGE FORM OF ADENOSINE AND USE OF ADENOSINE FOR THE MANUFACTURE OF MEDICAMENTS

Market Dynamics and Financial Trajectory for Adenoscan (Adenosine)

Last updated: February 20, 2026

What Is Adenoscan and Its Approved Indications?

Adenoscan (adenosine) is a pharmacological agent used primarily in cardiac stress testing procedures. It is administered to evaluate coronary artery disease by inducing vasodilation of coronary vessels, enabling imaging of blood flow differences. The drug received FDA approval in 1991 and is marketed under the brand name Adenoscan by GE Healthcare.

Its common application involves pharmacologic stress testing with myocardial perfusion imaging, which helps identify areas of reduced blood flow. The drug is administered via intravenous infusion, with testing protocols established for stress assessment.

How Does the Market for Adenoscan Operate?

The core market includes cardiology practices and imaging centers conducting myocardial perfusion imaging (MPI). Industry dynamics rely on several factors:

• Demand Drivers: Increasing incidence of coronary artery disease (CAD), expanding use of diagnostic imaging, and rising aging populations globally. The World Health Organization estimates that CAD accounts for roughly 16% of all deaths (WHO, 2019).
• Competitive Landscape: Alternatives include pharmacologic stress agents such as regadenoson (Lexiscan), dipyridamole, and dobutamine. Regadenoson has gained popularity due to ease of administration and shorter protocols.
• Market Share Trends: Adenoscan dominated in the 2000s but has faced competitive pressure. Regadenoson now captures a significant market portion due to convenience and safety profile.
• Regulatory Environment: Approval status varies by jurisdiction, but no recent major regulatory changes have significantly impacted adenoscans’ market presence.
• Reimbursement Policies: CPT codes like 78595 for nuclear cardiology imaging support reimbursement, although shifts favoring newer agents impact profitability.

What Are the Key Market Players and Their Strategic Positions?

• GE Healthcare: Manufactures and markets Adenoscan, leveraging established relationships with hospitals and imaging centers. Investments focus on expanding global access.
• Lantheus Holdings: Offers alternative agents, such as regadenoson (Lexiscan). The company's focus on novel agents introduces competitive pressure.
• Other Competitors: Bracco Imaging markets vasodilator agents, but Adenoscan remains a leading product in its category historically.

What Is the Financial Outlook for Adenoscan?

Recent sales figures are not publicly disclosed; however, insights include:

• Market Size Estimate: The global myocardial perfusion imaging agent market was valued at approximately $1.2 billion in 2021, expected to grow at a compound annual growth rate (CAGR) of about 7% until 2028 (ResearchAndMarkets, 2022).
• Adoption Trends: Decline compared to regadenoson indicates a shifting preference, with regadenoson holding a 35% share in the US MPI agent market as of 2022, up from nearly 0% in 2010 (IQVIA, 2022).
• Pricing and Reimbursement: Average per-test costs for Adenoscan-based MPI range from $2,000 to $4,000, depending on geographic and institutional factors.
• Market Penetration Challenges: Newer agents with simplified protocols reduce Adenoscan’s market share. Its revenue stream faces erosion unless targeted toward specific patient subsets where it remains preferred.

What Are the Regulatory and Commercial Risks?

• Patent and Regulatory Status: No recent patent filings or exclusivity extensions are apparent. Competition from FDA-approved alternatives constrains pricing power.
• Market Adoption Barriers: Preference for regadenoson due to faster protocols and safety profiles limits growth prospects.
• Clinical Guidelines and Reimbursement Trends: As professional societies endorse agents like regadenoson, reimbursements favor newer agents, challenging Adenoscan’s profitability.

What Are the Potential Growth Opportunities?

• Niche Applications: Specific patient populations with contraindications for other agents preserve demand.
• Global Expansion: Emerging markets with increasing access to advanced imaging can sustain sales.
• Combination Diagnostics: Integration with novel imaging techniques may extend current applications.

Effectiveness of Current Market Position

Adenoscan’s relevance diminished over the past decade due to:

• Preference for regadenoson, which offers simplified administration.
• Evolving clinical guidelines favoring newer agents.
• Market shift toward protocols requiring less preparation time.

However, Adenoscan maintains a niche segment primarily in regions with regulatory or clinical inertia.

Conclusion

Adenoscan remains a component of the cardiac stress testing market but faces declining market share driven by:

• Introduction of regadenoson with advantageous safety and administration profiles.
• Evolving clinical practices favoring newer agents.
• Cost and reimbursement pressures.

Its market trajectory depends on geographic expansion and niche applications rather than broad growth prospects, with long-term viability contingent on maintaining a specialized user base.

Key Takeaways

• Adenoscan’s market is shrinking as regadenoson and other agents replace it for routine myocardial perfusion imaging.
• Global growth is driven by increasing CAD prevalence and expanding imaging infrastructure.
• Financial performance is limited by competitive pressures and regulatory shifts favoring newer agents.
• Opportunities exist in select patient groups and emerging markets.
• Future market share depends on clinical guidelines and reimbursement policies favoring simplified protocols.

FAQs

1. How does Adenoscan differ from regadenoson in clinical application?
   Adenoscan requires continuous infusion over several minutes and has more contraindications, while regadenoson is administered as a bolus, with a shorter procedure time and a better safety profile.

2. What factors influence reimbursement for MPI agents like Adenoscan?
   Reimbursement depends on CPT coding, regional policies, and whether the agent aligns with updated clinical guidelines and preferred protocols.

3. Can Adenoscan be used outside cardiac stress testing?
   Its primary and FDA-approved indication is for myocardial perfusion imaging; off-label use is limited and not widespread.

4. What are the main competitors to Adenoscan globally?
   Regadenoson (Lexiscan), dipyridamole, and dobutamine are leading alternatives.

5. Is Adenoscan a focus for R&D investment?
   No, given its declining market share and competition, R&D efforts are limited; focus shifts to newer agents with better safety and administrative profiles.

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References

1. World Health Organization. (2019). Cardiovascular Diseases (CVDs). WHO.
2. ResearchAndMarkets. (2022). Global Myocardial Perfusion Imaging Agents Market.
3. IQVIA. (2022). Market Data and Insights on Cardiology Imaging Agents.