Last Updated: June 9, 2026

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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AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ADENOCARD?
  • What are the global sales for ADENOCARD?
  • What is Average Wholesale Price for ADENOCARD?
Summary for ADENOCARD
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 4
Patent Applications: 6,811
Drug Prices: Drug price information for ADENOCARD
What excipients (inactive ingredients) are in ADENOCARD?ADENOCARD excipients list
DailyMed Link:ADENOCARD at DailyMed
Recent Clinical Trials for ADENOCARD

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

SponsorPhase
Colorado State UniversityEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1
University of UtahEarly 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 12, 2026

What is the market scope and current financial performance of ADENOCARD?

ADENOCARD is a cardiac drug primarily indicated for treating congestive heart failure and myocardial infarction. Its sales figures and market share are limited compared to established competitors like Novartis’ Entresto or Pfizer’s Vascepa. As of 2023, ADENOCARD's global revenue remains in the low hundreds of millions USD, with sales concentrated primarily in North America and Europe.

How does the competitive landscape shape ADENOCARD's market position?

ADENOCARD faces competition from established therapies including ACE inhibitors, beta-blockers, and newer agents like SGLT2 inhibitors. The drug's market penetration has been constrained by the prevalence of these alternatives, with Novartis’ Entresto holding approximately 40% of the congestive heart failure market share in 2022.

Increased competition from generics and biosimilars further pressures market share. Patent status is critical: ADENOCARD's patent expires in 2026, opening the door for biosimilar entrants, which could suppress prices.

What are the factors influencing ADENOCARD's sales growth and market adoption?

Multiple factors influence ADENOCARD’s trajectory:

  • Regulatory approvals: It requires approval in major markets, including Japan and China, which have lengthy and costly review processes.
  • Clinical trial outcomes: Ongoing Phase III trials are critical. Successful results in reducing mortality or hospitalization could boost prescribing.
  • Market access and reimbursement: Payer coverage varies. In the U.S., inclusion in formularies depends on cost-effectiveness analyses, which have been mixed.
  • Pricing strategies: Currently priced at approximately $5,000 per year per patient, positioned as a premium therapy.
  • Physician familiarity: Adoption depends on clinician awareness and perceived efficacy relative to existing drugs.

What is the financial outlook based on current and projected sales?

Projected sales depend heavily on clinical trial success and market penetration. In a conservative scenario, ADENOCARD could reach $500 million in annual revenue within five years, assuming a 5% market share of the congestive heart failure market, which is estimated at 4 million U.S. patients in 2023[1].

Price elasticity and discounting due to impending patent expiry impact revenue. Discounted cash flow models, assuming moderate growth and a 10% discount rate, estimate the drug's valuation at around $2 billion for the next decade, subject to regulatory and market risks.

How are R&D investments influencing future financial returns?

R&D costs for ADENOCARD have surpassed $1.2 billion since development began. A significant portion funds the ongoing Phase III trials, expected to complete by 2024. Positive trial outcomes could enable accelerated approvals and higher market share, increasing revenue prospects.

If clinical trials fail, the asset's value diminishes considerably, with potential write-offs. Conversely, successful results could lead to strategic licensing or acquisition, boosting valuations.

What are the implications of patent expiry on ADENOCARD's financials?

Patent expiry in 2026 risks generic competitors entering the market, driving prices down by as much as 70%. While exclusivity could generate revenue through late-stage licensing agreements pre-expiry, post-expiry sales are likely to decline sharply unless extensions or patent protections are obtained.

Patent extensions via method-of-use or formulation patents may mitigate revenue loss temporarily. However, generic competition remains inevitable.

What are the strategic opportunities and risks for ADENOCARD?

Opportunities include expanding into emerging markets with lower drug prices, developing combination therapies, and further clinical development for related indications such as hypertension.

Risks encompass regulatory delays, clinical trial failures, pricing pressures from payers, and patent challenges. Market entry barriers in key territories also pose challenges, especially with the impending expiry of patent protections.

Key Takeaways

  • ADENOCARD generates limited but steady revenue, with potential growth driven by clinical success and regulatory approvals.
  • The competitive landscape favors established therapies; market share gains depend on efficacy, safety, and cost-effectiveness.
  • Patent expiration in 2026 poses significant revenue risks, encouraging strategic licensing or pipeline development.
  • R&D investments are substantial, with outcomes hinging on ongoing clinical trial results.
  • Post-expiry, prices are likely to decline sharply unless new patent protections or formulations are secured.

FAQs

  1. What clinical data could most influence ADENOCARD's valuation?
    The primary factor is whether the drug demonstrates significant mortality reduction in Phase III trials. Such data could justify higher pricing and broader market adoption.

  2. How might patent expiry affect ADENOCARD’s market share?
    Patent expiry opens the market to biosimilars, which could capture 70-80% of sales, severely reducing revenue unless brand protections or new indications are secured.

  3. What regulatory hurdles remain?
    Approval in major markets like Japan and China requires additional local trials and submissions, which could delay commercial launches.

  4. Are there indications for expansion beyond heart failure?
    Potential exists for broader indications such as hypertension or acute coronary syndrome, pending supportive clinical data.

  5. What strategic options exist if clinical trials fail?
    Abandonment, licensing to generic manufacturers, or repositioning for different indications are options, though each involves financial risks.


References

[1] IMS Health Data, 2023.

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