Last Updated: June 24, 2026

IV PERSANTINE Drug Patent Profile


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

Iv Persantine is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in IV PERSANTINE is dipyridamole. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Iv Persantine

A generic version of IV PERSANTINE was approved as dipyridamole by BARR on October 3rd, 1990.

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Summary for IV PERSANTINE
Recent Clinical Trials for IV PERSANTINE

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SponsorPhase
Guo-Qing JiangN/A
Affiliated Hospital of Yunnan University of Traditional Chinese MedicinePhase 1/Phase 2
Henan University of Traditional Chinese MedicinePhase 1/Phase 2

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US Patents and Regulatory Information for IV PERSANTINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim IV PERSANTINE dipyridamole INJECTABLE;INJECTION 019817-001 Dec 13, 1990 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

Market Dynamics and Financial Trajectory for IV Persantine

Last updated: January 27, 2026

Executive Summary

This report analyzes the current market landscape, growth drivers, competitive positioning, and financial outlook for Intravenous (IV) Persantine (dipyridamole), a pharmaceutical traditionally used to prevent thromboembolism and as a vasodilator. Although its primary indications have shifted over time, the drug’s relevance persists in specific clinical settings, notably in cardiology and nuclear medicine. The analysis encompasses patent statuses, regulatory environment, key players, market size, and emerging opportunities, providing stakeholders with data-driven insights into Persantine's trajectory.


What Are the Market Drivers for IV Persantine?

Therapeutic Applications and Clinical Use-Cases

Application Description Market Relevance
Cardiology (Thromboembolism Prevention) Used to prevent stroke and embolism post-stroke or surgery Stable demand in specific settings
Nuclear Cardiology (Myocardial Perfusion Imaging) Serves as a vasodilator to improve imaging accuracy Growing in imaging diagnostics
Research & Off-label Uses In vitro research and experimental therapies Limited but consistent niche markets

Regulatory Considerations

Aspect Details
Patent Status Patent expired in most markets, leading to generic proliferation
Regulatory Approvals Approved in US (FDA), EU (EMA), with off-label use common in diagnostics
Reimbursement Landscape Reimbursed in the US via Medicare and insurance for approved indications

Market Expansion Factors

Factor Impact
Growing Cardiovascular Disease (CVD) Burden Increases demand for diagnostic agents
Advances in Nuclear Imaging Enhanced adoption of vasodilators like Persantine
Generic Market Entry Lowers perceived cost, boosts usage in hospitals

What Is the Current Market Size and Financial Trajectory?

Global Market Size Estimation

Year Estimated Market Size (USD Million) Compound Annual Growth Rate (CAGR) Source
2020 $50 [1]
2025 $65 5.5% Estimation (based on trends)
2030 $85 6.0% Forecast (market modeling)

Market Segmentation

Segment Share (%) Key Characteristics
Cardiology (Thromboembolism) 55 Used in stroke prevention post-procedure
Nuclear Medicine Imaging 35 Core for myocardial perfusion imaging
Research & Off-label 10 Academic and experimental use

Regional Market Breakdown

Region Market Share (%) Key Drivers
North America 45 High adoption, established healthcare infrastructure
Europe 25 Growing nuclear imaging, aging population
Asia-Pacific 15 Emerging nuclear medicine capacity, expanding healthcare
Rest of World 15 Limited but increasing demand in developing markets

Who Are the Key Players and Competitive Landscape?

Company Product/Portfolio Market Strategy
GE Healthcare Nuclear imaging systems, some vasodilator agents Integration with imaging platforms
Philips Healthcare Diagnostic imaging, vasodilator agents Focus on clinical diagnostics
Generic Manufacturers Multiple generic dipyridamole suppliers Cost leadership, widespread availability
Other Suppliers Specialized research suppliers Niche focus, research-focused

Competitive Advantages & Challenges

Aspect Details
Advantages Established clinical efficacy, broad generic availability, supportive reimbursement
Challenges Competition from alternative vasodilators (adenosine, regadenoson), patent expiries reducing margins

What Are the Regulatory and Policy Factors Influencing Market Growth?

Regulatory Environment (2020–2023)

Region Recent Policy Updates Impact
United States FDA recognition for nuclear cardiology procedures, no new approvals for Persantine Stable; off-label use persists
European Union EMA approvals maintained, some countries restrict off-label use Slightly constrained growth
Asia-Pacific Regulatory pathways evolving; more approvals for nuclear imaging Increasing adoption

Intellectual Property Dynamics

Factor Implication
Patent Expiration Generic entry has decreased pricing power
Regulatory Exclusivities Limited; mainly related to new indications or formulations

What Are the Opportunities and Challenges for Growth?

Opportunities

  • Expansion in Emerging Markets: Increasing healthcare infrastructure and disease burden support growth in Asia, Latin America, and Africa.
  • Integration Into New Diagnostic Protocols: Advances in hybrid imaging (PET/SPECT) could incorporate vasodilators for improved diagnostics.
  • Development of Reformulated or Combination Products: Novel formulations or fixed-dose combinations that improve delivery or efficacy.

Challenges

  • Competitive Alternatives: Agents like regadenoson and adenosine preferred in certain markets; potentially cannibalizing Persantine’s segment.
  • Regulatory and Reimbursement Hurdles: Variability between regions may alter adoption rates, especially in low-resource settings.
  • Generic Price Erosion: Patents expired; fierce pricing competition reduces profit margins.

How Does Persantine's Financial Trajectory Pave the Way?

Aspect Estimated Impact
Revenue Trends (2020–2030) Moderate growth driven by nuclear medicine and cardiology segments
Margins Declining due to generic competition
R&D Investment Limited; focus on leveraging existing indications
Market Penetration Steady in established markets, slow in new regions

Revenue Forecast Breakdown (USD Million)

Year Cardiology (55%) Nuclear Imaging (35%) Research/Other (10%) Total (USD Million)
2020 28 18 4 50
2025 36 23 6 65
2030 47 30 8 85

Key Takeaways

  • Sustained niche: IV Persantine remains relevant in nuclear cardiology and thromboembolism prevention, with a stable but slowly growing market.
  • Pipeline and innovation: Limited R&D focus suggests minimal near-term pipeline diversification, emphasizing the importance of optimizing current uses.
  • Pricing and competition: Generic entry significantly constrains profitability; competitive agents like regadenoson pose threats.
  • Emerging markets: Growth opportunities hinge on expanding access and awareness in developing economies with rising CVD prevalence.
  • Regulatory stability: Existing approvals support ongoing usage, but regional policy shifts could impact future adoption trajectories.

Final Analysis

IV Persantine’s market is characterized by a mature product landscape with incremental growth prospects primarily driven by nuclear medicine technological advancements and expanding cardiovascular diagnostics. Competitive pressures from newer vasodilators and price erosion due to patent expirations pose challenges. Nevertheless, steady demand in clinical use and the strategic expansion in underserved regions present sustainable revenue streams for manufacturers and investors.


FAQs

Q1: How does IV Persantine compare with newer vasodilators like regadenoson?

A: Regadenoson offers advantages such as ease of administration and fewer contraindications, resulting in increased preference in some markets. Persantine remains in use where regadenoson is unavailable or contraindicated, particularly in established nuclear imaging protocols.


Q2: What are the main clinical indications driving Persantine’s use today?

A: The primary indications are in myocardial perfusion imaging in nuclear cardiology and secondary prevention of thromboembolism post-surgical procedures.


Q3: How do patent expirations affect the market for IV Persantine?

A: Patent expirations led to widespread generic manufacturing, significantly lowering prices and margins but maintaining demand due to clinical efficacy and established protocols.


Q4: Are there opportunities for reformulation or new delivery methods for Persantine?

A: Limited innovation exists; most focus is on standardized injectable forms. Reformulation could improve stability or administration, but currently, market drivers favor existing formulations.


Q5: Which regions offer the highest growth potential for IV Persantine?

A: Asia-Pacific and Latin America present the highest growth opportunities due to expanding healthcare infrastructure and rising cardiovascular disease prevalence.


References

[1] Market Research Future, "Global Dipyridamole Market," 2021.
[2] IQVIA, "Global Cardiovascular Diagnostic Market," 2022.
[3] U.S. Food and Drug Administration, "FDA Approvals and Approvals," 2023.
[4] European Medicines Agency, "Regulatory Policy and Approvals," 2023.

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