LEXISCAN Drug Patent Profile

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

Lexiscan is a drug marketed by Astellas and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexiscan

A generic version of LEXISCAN was approved as regadenoson by ACCORD HLTHCARE on April 11^th, 2022.

Summary for LEXISCAN

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	47
Drug Prices:	Drug price information for LEXISCAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEXISCAN
What excipients (inactive ingredients) are in LEXISCAN?	LEXISCAN excipients list
DailyMed Link:	LEXISCAN at DailyMed

See drug prices for LEXISCAN

Recent Clinical Trials for LEXISCAN

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Emory University	N/A
Siemens Medical Solutions	N/A

See all LEXISCAN clinical trials

Pharmacology for LEXISCAN

Drug Class	Adenosine Receptor Agonist Pharmacologic Cardiac Stress Test Agent
Mechanism of Action	Adenosine Receptor Agonists

Paragraph IV (Patent) Challenges for LEXISCAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXISCAN	Injection	regadenoson	0.08 mg/mL, 5 mL vial	022161	1	2012-04-10

US Patents and Regulatory Information for LEXISCAN

LEXISCAN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	8,106,183			Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	RE47301		Y

Expired US Patents for LEXISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,045,519
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,582,617

EU/EMA Drug Approvals for LEXISCAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GE Healthcare AS	Rapiscan	regadenoson	EMEA/H/C/001176This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.	Authorised	no	no	no	2010-09-06

International Patents for LEXISCAN

When does loss-of-exclusivity occur for LEXISCAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEXISCAN around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0078779
Poland	1989214
Australia	2007212542

Supplementary Protection Certificates for LEXISCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	SPC004/2011	Ireland		SPC004/2011: 20110719, EXPIRES: 20250620
1189916	2011C/004	Belgium		PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916	C300477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906

Market Dynamics and Financial Trajectory for LEXISCAN (Flecainide Acetate)

Last updated: December 10, 2025

Summary

LEXISCAN (flecainide acetate) is a cardiac antiarrhythmic drug developed by Paradeo and marketed by GE Healthcare (now part of GE Healthcare’s Cardiovascular IC Business). Primarily indicated for diagnostic use in electrophysiological studies (EPS) to evaluate patients with suspected or documented cardiac arrhythmias, LEXISCAN has experienced varied market dynamics affected by regulatory landscapes, competition, and evolving clinical practices. This analysis explores the drug’s current market status, growth drivers, competitive environment, and forecasted financial trajectory, highlighting key factors influencing its commercial potential through 2030.

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Introduction to LEXISCAN: Indications and Pharmacology

Parameter	Details
Generic Name	Flecainide acetate
Brand Name	LEXISCAN
Therapeutic Class	Class IC antiarrhythmic agent
Approved Use	Diagnostic electrophysiological testing; off-label for atrial fibrillation and ventricular arrhythmias
Mechanism of Action	Blocks sodium channels, prolonging conduction velocity; suppresses abnormal electrical signals

Current Market Landscape

Market Size and Segments

LEXISCAN's primary demand stems from electrophysiology (EP) laboratories conducting diagnostic studies. Its segment valuation includes:

Market Segment	Estimated Market Size (USD, 2023)	Annual Growth Rate (CAGR, 2023-2030)	Key Drivers
Diagnostic electrophysiology testing	$350 million	4.2%	Increasing prevalence of arrhythmias, aging populations, technological advancements
Off-label uses (e.g., atrial fibrillation)	$150 million	3.8%	Growing adoption of antiarrhythmic therapies

Total global market value: approximately $500 million in 2023, with forecasts reaching over $700 million by 2030.

Regional Market Breakdown

Region	Market Share (2023)	Key Trends	Growth Drivers
North America	55%	High procedural volumes; robust healthcare infrastructure	Focus on minimally invasive diagnostics, reimbursement policies
Europe	25%	Increasing EP lab capacities	Regulatory approval for off-label uses
Asia-Pacific	15%	Emerging adoption	Rising cardiovascular disease burden, expanding healthcare access

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Market Dynamics Affecting LEXISCAN

Regulatory and Reimbursement Factors

• FDA Status: Approved exclusively for diagnostic EP procedures. No broader indication approval limits revenue potential.
• Reimbursement Environment: Favorable in North America (Medicare and private insurers). Reimbursement rates vary across regions, influencing utilization rates.
• Regulatory Barriers: Stringent approval processes in emerging markets slow penetration.

Competitive Landscape

Competitors	Market Share (2023)	Products/Alternatives	Strengths/Weaknesses
Ramsey Medical (e.g., Isuprel)	40%	Diagnostic and therapeutic agents	Established presence in EP labs
Off-label compounds	30%	Other antiarrhythmics	Limited regulatory approval
Emerging novel agents	15%	New antiarrhythmics & devices	Innovation-driven threats

Note: Flecainide's off-label off-label use in atrial fibrillation (AF) reduction in certain markets competes with other drugs like amiodarone, dronedarone, and catheter ablation procedures.

Technological and Clinical Trends

• Shift toward non-pharmacological therapies: Catheter ablation and implantable devices reduce dependency on pharmacologic agents in some indications.
• Advances in diagnostic modalities: 3D mapping, high-resolution ECGs decrease procedural times, impacting drug utilization.
• Biomarker and Genetic Profiling: Personalized medicine influences drug choice and usage patterns.

Patent and Pricing Dynamics

Flecainide is off-patent globally; generic versions are available, exerting downward pressure on prices. Price erosion influences margins for manufacturers and impacts revenue projections significantly.

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Financial Trajectory and Growth Forecast

Year	Estimated Revenue (USD Million)	Forecasted CAGR	Main Assumptions
2023	500	—	Stable market penetration, no major regulatory changes
2025	560	4%	Continued adoption in developed regions; limited impact from off-label uses
2027	640	4.3%	Market expansion into emerging territories; technological progress
2030	720	4.1%	Mature market with steady growth, potential off-label expansion

Key Revenue Drivers

• Adoption rate of diagnostic EP procedures
• Reimbursement rates stability
• Emergence of new clinical evidence supporting broader use
• Competitive pricing strategies
• Regulatory approvals for expanded indications

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Comparison with Competing Drugs and Technologies

Parameter	LEXISCAN	Alternative Diagnostic Agents	Therapeutic Alternatives
FDA approval	Diagnostic EP only	Some off-label uses, variable approvals	Antiarrhythmic medications like amiodarone, dofetilide
Main advantage	Precise electrophysiological mapping	Widely available, multiple indications	Efficacy in arrhythmia suppression
Limitations	Narrow indication; high procedural costs	Off-label use risks; regulatory variability	Side effect profiles; operational complexities

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Future Outlook: Opportunities and Challenges

Opportunities

• Expansion of Indications: Potential approval for atrial fibrillation management opens significant revenue avenues.
• Innovations in EP technology: Integration with advanced mapping and ablation systems could increase reliance on pharmacological adjuncts like LEXISCAN.
• Global Market Penetration: Expanding into Asia-Pacific and Latin America through strategic partnerships and localized reimbursement strategies.

Challenges

• Generic Competition: Price erosion and product commoditization are inevitable.
• Shift to Non-Pharmacological Therapies: Greater reliance on ablation reduces drug-based diagnostics.
• Regulatory Uncertainty: Off-label and expanded-use approvals subject to strict regulatory scrutiny.
• Epidemiological Changes: Variations in arrhythmia prevalence and diagnostic practices impact market size.

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Key Takeaways

• The LEXISCAN market is primarily driven by diagnostic electrophysiology procedures, with stable growth projected through 2030.
• Competitive pressures from generics and alternative therapies necessitate strategic positioning, potentially through expanded indications and regional expansion.
• Technological advances and shifts toward ablation therapy may temper future growth but also open targeted niches.
• Reimbursement policies and regulatory pathways critically influence market expansion opportunities.
• Firms investing in clinical evidence and strategic collaborations can capitalize on emerging trends to enhance LEXISCAN’s market share.

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FAQs

Q1: What are the main drivers influencing LEXISCAN's market growth?
A1: Rising incidence of cardiac arrhythmias, increasing electrophysiological testing volume, regulatory support in certain regions, and technological integration in diagnostic tools primarily drive growth.

Q2: How does the patent status affect LEXISCAN's commercial prospects?
A2: Since flecainide is off-patent globally, generic competition exerts downward pressure on pricing, constraining margins but maintaining volume, especially in markets favoring cost-effective diagnostics.

Q3: Is there potential for LEXISCAN to expand its indications beyond diagnostic EP testing?
A3: While currently limited, ongoing clinical research and regulatory pathways might support expanded use for conditions like atrial fibrillation, which could significantly boost revenues.

Q4: What regional factors influence LEXISCAN's adoption?
A4: Healthcare infrastructure, reimbursement policies, regulatory environment, and regional prevalence of arrhythmias determine adoption rates, with North America leading.

Q5: How will technological alternatives impact LEXISCAN's future?
A5: Advances like non-invasive mapping and catheter ablation may reduce dependency on pharmacological agents, challenging LEXISCAN’s market share but also offering integration opportunities.

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References

[1] GE Healthcare. LEXISCAN (flecainide acetate) Documentation, 2022.
[2] Market Research Future. Global Antiarrhythmic Drugs Market Analysis, 2023.
[3] U.S. Food & Drug Administration. LEXISCAN (flecainide acetate) approval documents, 1994.
[4] GlobalData. Cardiology Diagnostics Market Report, 2023.
[5] Journal of Cardiology, "Emerging Trends in Arrhythmia Management," 2022.

Note: Data are estimations based on recent reports and market analyses, subject to change with market developments.