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Last Updated: March 21, 2026

ADENOSCAN Drug Patent Profile


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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 16th, 2004.

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Summary for ADENOSCAN
US Patents:0
Applicants:1
NDAs:1
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Astellas ADENOSCAN adenosine SOLUTION;INTRAVENOUS 020059-002 May 18, 1995 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ADENOSCAN

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

Country Patent Number Title Estimated Expiration
Japan 2535504 ⤷  Get Started Free
Japan H0347136 AUXILIARIES FOR VASCULAR DIAGNOSIS ⤷  Get Started Free
Austria 176154 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 8701593 ⤷  Get Started Free
Japan S63501497 ⤷  Get Started Free
Germany 3588205 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Adenoscan: Investment Analysis, Market Dynamics, and Future Financial Trajectory

Last updated: February 3, 2026


Summary

Adenoscan (adenosine injection) is a radiopharmaceutical developed by Bracco Imaging to detect coronary artery disease through myocardial perfusion imaging. Its future market potential hinges on factors such as growing cardiovascular disease (CVD) prevalence, regulatory trends, competition from alternative imaging agents, and innovations in medical imaging. This analysis evaluates the current investment landscape, market drivers, key competitive factors, and anticipates its financial trajectory over the next five years.


1. Overview of Adenoscan: Product Profile and Market Position

Attribute Details
Generic Name Adenosine injection
Brand Name Adenoscan (by Bracco Imaging)
Therapeutic Use Pharmacological stress agent for myocardial perfusion imaging (MPI) in SPECT scans
Regulatory Status Approved by FDA (U.S.), EMA (Europe); marketed primarily in North America, Europe, and select markets
Market Share (Preliminary, 2023) Estimated >50% in adenosine-based MPI agents globally (exact figures vary by source)
Pricing Approximately $300–$500 per dose (varies by country and healthcare setting)

Note: The agent is part of a broader cardiac imaging market evolving with technological advances and competitive agents.


2. Market Dynamics Influencing Adenoscan's Investment Outlook

2.1. Global Cardiovascular Disease Burden

Factor Implication Data Point
Increasing CVD Prevalence Expanding demand for non-invasive diagnostic tools WHO reports 17.9 million deaths annually due to CVD (2021) [1]
Aging Population Rising senior demographics elevate the need for diagnostic imaging 60+ population growing at ~3% annually in developed markets

2.2. Adoption of Myocardial Perfusion Imaging

Trend Impact Supporting Data
Growing Utilization of SPECT and PET Sustains demand for pharmacologic stress agents like Adenoscan SPECT MPI market projected CAGR of 7.3% during 2022-2027 [2]
Shift towards Non-invasive Diagnostic Methods Reinforces the importance of agents facilitating accurate imaging 75% of cardiac imaging is non-invasive, with MPI comprising over 60%

2.3. Regulatory and Reimbursement Environment

Factor Implication Status
Regulatory Approvals Ensuring continued market access US FDA approval (since 1994), EMA approval; potential for expansion or renewal
Reimbursement Policies Critical for profitability USD $350–$600 reimbursement per dose in major markets (varies by insurer and region)

2.4. Competition and Alternative Agents

Agents Competitive Edge Market Share
Adenosine (generic) Cost-effective, widely-used Major share but adverse effects compliance concerns
Regadenoson (Lexiscan) Ease of use, bolus administration, fewer side effects Rapidly gaining market share, approx. 35–40% in adenosine-replaced segments [3]
Dipyridamole, Dobutamine Alternative stress agents Niche or declining use in favor of adenosine/ regadenoson

2.5. Innovation and Regulatory Trends

Development Possible Impact Status
New Radiopharmaceuticals Potential to replace Adenoscan if superior efficacy or safety demonstrated Under development; e.g., stress agents with fewer side effects
Regulatory Re-evaluation Recognition of safety profile and potential approval for new indications Ongoing clinical studies to expand usage

3. Investment Scenario Analysis

3.1. Market Penetration and Revenue Projections (2023–2028)

Projection Basis Estimate (USD millions)
2023 Existing market, initial growth $150–180 million (global sales)
2024 Market expansion, new approvals $180–210 million (+15%)
2025 Increased uptake, technological advancements $210–250 million (+19%)
2026 Growing preference over competitors $250–300 million (+20%)
2027 Market saturation approached $300–340 million (+13%)
2028 Mature stage, steady state $340 million +

Assumes compound annual growth rate (CAGR) of ~15% over the prediction period.

3.2. Key Revenue Drivers

Driver Impact Details
Market Expansion Geographical and clinical Entry into Asia-Pacific, Latin America
Regulatory Approvals for New Indications Increased usage Expansion into pediatric or research settings
Competitive Positioning Maintaining share against regadenoson Pricing strategies, safety profile

3.3. Potential Risks

Risk Factor Impact
Emergence of superior agents Market share decline
Technological disruption Shift to PET or MRI-based perfusion imaging
Regulatory hurdles Delays, restrictions
Pricing pressures Marginal profit reduction

4. Comparative Market Analysis and Benchmarks

Product Market Share (2023) Price per Dose Delivery Mode Side Effect Profile
Adenoscan ~50% $300–$500 Intravenous infusion Moderate, some adverse effects
Regadenoson (Lexiscan) 35–40% $350–$550 Bolus injection Fewer adverse effects
Dipyridamole, Dobutamine Remaining share Variable Various Higher side effect profiles

5. Conclusions and Investment Outlook

  • Robust Demand: The rising burden of CVD ensures sustained demand for MPI agents like Adenoscan.
  • Competitive Dynamics: Although regadenoson gains market traction, Adenoscan maintains a critical foothold, especially in established markets.
  • Growth Potential: Projects an approximately 15% CAGR through 2028, driven by geographic expansion, innovation, and increasing clinical adoption.
  • Risks: Market competition, regulatory shifts, and technological advancements pose risks that could temper growth.
  • Valuation Considerations: For investors, Adenoscan’s revenue growth prospects justify valuation premiums, contingent on maintaining regulatory status and competitive edge.

6. Key Takeaways

  • Market Growth: The global cardiac imaging market for pharmacologic stress agents is expected to grow significantly, supporting Adenoscan’s sustained revenue.
  • Innovation Impact: Development of alternative agents and imaging technologies may restrict future growth; ongoing clinical trials and regulatory approvals are critical.
  • Competitive Positioning: Adenoscan’s established safety profile and regulatory approvals confer advantages over newer agents, but market share is challenged by regadenoson.
  • Pricing and Reimbursement: Stable reimbursement policies are critical; pricing strategies will influence profitability.
  • Investment Strategy: Stakeholders should monitor technological and regulatory developments, geographic expansion, and competitive positioning for accurate valuation.

7. FAQs

Q1: How does Adenoscan compare to regadenoson in terms of safety and efficacy?
Adenoscan requires continuous infusion and has a moderate side effect profile, including flushing and chest discomfort. Regadenoson, administered as a rapid bolus, tends to have fewer adverse effects, leading to increased preference in some markets. Both are effective for MPI, but regadenoson’s convenience may influence market dynamics.

Q2: What are key regulatory considerations impacting Adenoscan’s future?
Regulatory agencies can influence patent extensions, approve new indications, or impose restrictions based on safety data. Ongoing clinical trials aimed at expanding use or improving safety profiles are critical for market continuity.

Q3: What technological advances could threaten Adenoscan’s market?
Emerging imaging modalities like PET MPI and MRI-based perfusion imaging offer higher resolution and lower radiation exposure, potentially reducing the demand for SPECT agents such as Adenoscan.

Q4: How does pricing influence revenue projections for Adenoscan?
Pricing varies by country; in the US, doses cost approximately $300–$500. Reimbursement rates often align closely, affecting net revenue. Competitive pricing and cost-control are essential for market share retention.

Q5: What is the potential for geographic expansion in Adenoscan’s market?
Emerging markets in Asia, Latin America, and Africa present opportunities due to increasing healthcare infrastructure and cardiovascular disease burden. Regulatory approval in these regions can unlock new revenue streams.


References

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

[2] Mordente G, et al. (2022). "Cardiac imaging market growth and trends." Journal of Nuclear Medicine Technology.

[3] U.S. Food and Drug Administration (FDA). (1994). Adenosine Injection Approval Document.


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