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Last Updated: December 15, 2025

ADENOCARD Drug Patent Profile


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When do Adenocard patents expire, and what generic alternatives are available?

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

The generic ingredient in ADENOCARD 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 Adenocard

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

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  • What is the 5 year forecast for ADENOCARD?
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Summary for ADENOCARD
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 4
Patent Applications: 6,006
Drug Prices: Drug price information for ADENOCARD
What excipients (inactive ingredients) are in ADENOCARD?ADENOCARD excipients list
DailyMed Link:ADENOCARD at DailyMed
Drug patent expirations by year for ADENOCARD
Drug Prices for ADENOCARD

See drug prices for ADENOCARD

Recent Clinical Trials for ADENOCARD

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

SponsorPhase
Colorado State UniversityEarly Phase 1
University of UtahEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1

See all ADENOCARD clinical trials

US Patents and Regulatory Information for ADENOCARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas ADENOCARD adenosine INJECTABLE;INJECTION 019937-002 Oct 30, 1989 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ADENOCARD

Last updated: July 31, 2025


Introduction

Adenocard, the trade name for adenosine, is an established pharmaceutical agent primarily used in cardiac electrophysiology. Its unique mechanism—temporarily blocking atrioventricular (AV) nodal conduction—makes it invaluable for diagnosing supraventricular tachycardia (SVT). While its primary applications remain consistent, evolving market dynamics and competitive landscapes influence its financial trajectory significantly. This report examines the factors shaping Adenocard’s market and projects its financial outlook, incorporating regulatory, technological, and commercial trends.


Market Overview

Current Market Size and Usage

Adenocard has maintained a vital role in electrophysiology laboratories worldwide, with a global market size estimated at approximately $150 million in 2022 (estimated based on market research reports). The drug is designated as an essential medication in cardiology across multiple health systems due to its diagnostic utility and safety profile when administered by trained clinicians.

Key Indications and Revenue Drivers

  • Diagnostic Tool in Cardiology: Primarily used in determining the nature of SVT, especially when non-invasive tests are inconclusive.
  • Therapeutic Off-Label Uses: Occasionally employed for managing tachyarrhythmias, though off-label use does not significantly contribute to revenues.
  • Emergency Department Utilization: Limited but significant, particularly in acute care settings.

Market Dynamics

Regulatory Factors

Adenocard's regulatory pathway remains largely stable due to its established market authorization. However, ongoing scrutiny around safety—specifically concerning its side-effect profile—continues to influence prescribing patterns. The drug's patent exclusivity has long expired, which has facilitated generic competition, reducing prices and squeezing profit margins for branded manufacturers.

Competitive Landscape

  • Generic Competition: The expiry of patent protection enabled several manufacturers to introduce generic adenosine formulations, leading to a commoditized market. Price competition has been the most significant factor driving down revenue.
  • Emerging Therapies: There is a modest pipeline of alternative agents (e.g., calcium channel blockers, antiarrhythmics) that could substitute adenosine in some diagnostic scenarios, although none have yet displaced Adenocard's position fully.
  • Technological Innovations: Advancements in non-pharmacological diagnostic techniques like 3D mapping and remote electrophysiology systems have gradually supplemented medication-based diagnostics, potentially influencing future demand.

Market Penetration and Adoption

Despite competition and technological evolution, Adenocard remains the gold standard for AV nodal blockade during electrophysiology studies owing to its rapid onset and well-characterized safety profile. Adoption levels are high in developed markets, though cost constraints in emerging economies limit broader dissemination.

Reimbursement Environment

Reimbursement policies significantly impact revenue streams, especially in hospital settings. In regions with favorable coverage, usage remains steady; where reimbursement is limited, utilization declines, impacting global sales.


Financial Trajectory Insights

Historical Revenue Trends

Over the past decade, the revenues from Adenocard have experienced a decline driven primarily by:

  • Patent expirations leading to increased generics.
  • Pricing pressure from competitive markets.
  • Slower growth in new indications and adoption.

Despite these pressures, the drug's essential role sustains a baseline revenue, estimated at around $120–150 million/year globally.

Projected Future Revenue

The future financial trajectory hinges on multiple factors:

  • Market Penetration in Emerging Economies: As healthcare infrastructure improves, the expanding electrophysiology practice in Asia-Pacific and Latin America can offer growth opportunities.
  • Regulatory Approvals for New Indications: Although currently used mainly in cardiac diagnostics, potential approval for broader arrhythmia management could uplift sales.
  • Pricing Strategies: Manufacturers may explore value-based pricing or bundle offerings to maintain margins amid generic competition.
  • Technological Displacement Risks: The adoption of non-pharmacological diagnostic systems might shrink the total addressable market, offsetting potential gains from emerging markets.

In conservative estimates, revenues may stabilize around $100–130 million annually over the next 5 years, with potential for modest growth contingent on market expansion and technological integration.


Key Factors Influencing Future Market and Financial Outcomes

Factor Impact
Technological Innovations Potential to subvert pharmacological diagnostics, reducing dependence on Adenocard
Regulatory Environment Approvals or restrictions affecting off-label uses or new indications
Competitive Pricing and Generics Continued downward pressure on unit prices, compressing profit margins
Geographic Market Expansion Increased penetration in underpenetrated markets sustaining sales
Healthcare Policy and Reimbursement Favorable policies bolster adoption; restrictive policies hinder growth

Risks and Opportunities

Risks

  • Disruption from New Diagnostic Technologies: The rise of non-invasive, non-pharmacological diagnostics could replace Adenocard in certain settings.
  • Pricing Compression: Intense generic competition limits achievable margins.
  • Regulatory Changes: New safety concerns or classification shifts could restrict usage.

Opportunities

  • Market Expansion: Targeting emerging markets with increasing electrophysiology procedural volumes.
  • Product Line Extensions: Developing formulations for pediatric or specific acute care scenarios.
  • Combination Therapies and Diagnostics: Collaborations enhancing the utility of Adenocard within integrated medical devices.

Conclusion

Adenocard’s market environment remains largely stable but faces significant headwinds from generic competition and technological innovations. While revenues are currently steady, the future trajectory depends on strategic positioning within emerging markets, incremental innovation, and adaptation to evolving diagnostic paradigms. Companies leveraging geographic expansion and exploring new indications hold the best prospects for maintaining or modestly increasing Adenocard’s financial contribution in the global pharmaceutical landscape.


Key Takeaways

  • Market size is stable but declining at a slow rate due to generics and competition.
  • Emerging markets present growth opportunities, driven by expanding healthcare infrastructure.
  • Technological advancements could gradually diminish demand, necessitating strategic innovation.
  • Pricing pressures require manufacturers to optimize cost-efficiency and value-based offerings.
  • Regulatory and reimbursement policies are critical determinants in maintaining revenue streams.

FAQs

1. How does patent expiration affect Adenocard's market profitability?
Patent expiration introduces generic alternatives, significantly reducing prices and profit margins while increasing market competition. This transition shifts revenue reliance from branded to generic sales, often leading to decreased overall profitability.

2. Are there emerging therapies that threaten Adenocard’s clinical utility?
Yes, advanced cardiac mapping systems and non-invasive diagnostic tools are gradually supplementing or replacing pharmacologic diagnostic methods, which could impact Adenocard demand over time.

3. In which geographical regions does Adenocard have the highest usage?
Developed markets, particularly North America and Europe, exhibit the highest and most consistent utilization due to established electrophysiology services. Emerging markets are showing increased adoption as procedures expand.

4. Can Adenocard’s revenue increase through new indications?
While current indications are well-established, exploring additional diagnostic or therapeutic applications could potentially boost revenue if supported by clinical evidence and regulatory approval.

5. How does reimbursement influence Adenocard sales?
Reimbursement policies directly impact clinician adoption, especially in cost-sensitive healthcare systems. Favorable reimbursement encourages utilization; restrictive policies may slow sales growth.


References

  1. Market research estimates based on industry reports (e.g., Grand View Research, MarketWatch).
  2. Clinical guidelines and drug safety documentation.
  3. Industry publications on electrophysiology market trends and technological developments.

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