Regadenoson - Generic Drug Details

What are the generic drug sources for regadenoson and what is the scope of patent protection?

Regadenoson is the generic ingredient in two branded drugs marketed by Astellas, Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Ge Healthcare, Gland, Hikma, Hospira, Ims Ltd, Indies Pharma, Meitheal, and Mylan, and is included in fourteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has twenty-eight patent family members in eighteen countries.

There are nine drug master file entries for regadenoson. Eighteen suppliers are listed for this compound.

Summary for regadenoson

International Patents:	28
US Patents:	2
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	61
Patent Applications:	904
Drug Prices:	Drug price trends for regadenoson
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regadenoson
What excipients (inactive ingredients) are in regadenoson?	regadenoson excipients list
DailyMed Link:	regadenoson at DailyMed

See drug prices for regadenoson

Recent Clinical Trials for regadenoson

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

Sponsor	Phase
Brigham and Women's Hospital	NA
St. Jude Children's Research Hospital	Phase 2
Emory University	N/A

See all regadenoson clinical trials

Pharmacology for regadenoson

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

Anatomical Therapeutic Chemical (ATC) Classes for regadenoson

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for REGADENOSON

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 regadenoson

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indies Pharma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054-001	Aug 22, 2024	AP	RX	No	No
Mylan	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213856-001	Apr 4, 2023	AP	RX	No	No
Hospira	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	214349-001	Aug 31, 2022	AP	RX	No	No
Ge Healthcare	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	215955-001	Aug 5, 2024	AP	RX	No	No
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes				Y
Hikma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	215827-001	Feb 2, 2023	AP	RX	No	No
Meitheal	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	212806-001	Apr 11, 2022	AP	RX	No	No

Expired US Patents for regadenoson

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008

EU/EMA Drug Approvals for regadenoson

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 regadenoson

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1127358	製備種 型腺苷受體激動劑及其多晶形物的方法 (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS A2A)
Mexico	2010014060	PROCESO PARA PREPARAR UN AGONISTA DE RECEPTOR DE ADENOSINA A2A Y SUS POLIMORFAS. (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS.)
Norway	341322
European Patent Office	1989214	PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS)
China	102260311
Portugal	1989214
Australia	2007212542

Supplementary Protection Certificates for regadenoson

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	122011000010	Germany		PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/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
1189916	C01189916/01	Switzerland		PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	SZ 2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916	1190003-2.L	Sweden		PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
1189916	SPC/GB11/005	United Kingdom		PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1189916	2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906

Market Dynamics and Financial Trajectory for Regadenoson

Last updated: July 27, 2025

Overview of Regadenoson

Regadenoson is a selective A2A adenosine receptor agonist primarily used as a pharmacologic stress agent in myocardial perfusion imaging (MPI). Approved by the U.S. Food and Drug Administration (FDA) in 2008, it serves as a diagnostic tool in evaluating coronary artery disease (CAD) without the need for exercise stress testing. Its rapid onset of action and favorable safety profile have positioned it as a preferred agent in nuclear cardiology.

Market Landscape and Growth Drivers

Expanding Cardiology Diagnostics Market

The global cardiovascular diagnostics market is experiencing consistent growth, driven by increasing incidence and prevalence of CAD, an aging population, and advancements in non-invasive imaging technologies. According to Fortune Business Insights, the global cardiovascular diagnostics market is projected to reach USD 34.2 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 4.6% (2021–2028). Regadenoson benefits from this expansion as a key pharmacologic agent.

Advances in Imaging Technology

The integration of advanced imaging modalities, such as Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET), has increased reliance on pharmacologic stress agents like regadenoson. The agent’s quick administration and minimal side effects enhance procedural efficiency, fueling its adoption among cardiologists.

Regulatory and Reimbursement Environment

Supportive regulatory pathways and reimbursement policies in major markets bolster market growth. The Centers for Medicare & Medicaid Services (CMS) and private insurers increasingly reimburse MPI procedures involving regadenoson, incentivizing healthcare providers to adopt this agent.

Geographic Expansion

While North America remains the leading market due to high healthcare spending and established imaging infrastructure, emerging markets in Asia-Pacific, Latin America, and the Middle East show promising growth potential owing to increasing healthcare access, urbanization, and disease burden.

Market Challenges and Competitive Landscape

Competitive Pharmacologic Agents

Regadenoson faces competition from other stress agents such as adenosine, dipyridamole, and dobutamine. While regadenoson’s selective mechanism reduces side effects like bronchospasm and atrioventricular block, some clinicians prefer other agents due to familiarity or specific patient considerations.

Cost and Pricing Pressures

Price competition and reimbursement constraints impact profit margins. As generic versions or biosimilars emerge, price erosion could restrict revenue growth.

Supply Chain and Manufacturing Constraints

Supply chain disruptions, especially in the context of global crises such as COVID-19, pose risks to consistent product availability and sales momentum.

Regulatory Challenges

Potential regulatory hurdles in gaining approval for new indications or formulations could delay market penetration in emerging regions.

Financial Trajectory and Revenue Analysis

Revenue Performance

Since its initial commercialization, regadenoson has demonstrated steady revenue streams. According to IQVIA sales data, the global sales of regadenoson products, primarily Lexiscan by Astellas Pharma, peaked at approximately USD 250 million in 2019. Post-pandemic recovery, sales are trending upward as diagnostic volumes rebound, supported by increased cardiovascular screening.

Market Penetration Strategies

Astellas Pharma’s strategic pricing, expanding global footprint, and ongoing clinical studies support revenue growth. Licensing agreements with regional partners facilitate penetration into less mature markets.

Forecasting Future Revenue

Based on current market drivers and competitive dynamics, industry analysts project a CAGR of 3–5% for regadenoson-related revenues over the next five years. Factors such as technological innovation, rising cardiovascular disease rates, and increased clinical adoption underpin this trajectory.

Impact of Development Pipelines and Formulations

Pipeline development, like potential new formulations with extended shelf life or combined diagnostic agents, could stimulate incremental revenue. However, the market remains heavily dependent on existing formulations and clinical adoption rates.

Market Entry and Expansion Opportunities

Innovative Indications

Exploration of regadenoson for new imaging indications, such as assessment of cerebrovascular or peripheral vascular diseases, could diversify revenue streams.

Regulatory Approvals in Emerging Markets

Securing approvals in regions like China, India, and Brazil could unlock significant revenue growth due to their large patient populations and increasing cardiology service penetration.

Partnerships and Collaborations

Partnerships with diagnostic imaging providers and regional distributors are crucial for expanding access and improving sales volumes.

Key Market Players

• Astellas Pharma Inc. (Lexiscan): Dominant supplier with significant market share and ongoing clinical research initiatives.
• GE Healthcare and Siemens Healthineers: Competitors offering alternative pharmacologic agents or imaging systems.
• Generic Manufacturers: Emerging players developing biosimilars or generics, threatening pricing power.

Regulatory and Reimbursement Outlook

Regulatory bodies across major markets continue to endorse regadenoson’s safety and efficacy, supporting its longstanding use. Reimbursement policies remain favorable in the U.S. and Europe, but price pressures remain a concern. Policymakers’ emphasis on cost-effectiveness and the adoption of alternative testing modalities could influence future reimbursement levels.

Conclusion: Financial and Market Outlook

The outlook for regadenoson remains cautiously optimistic. While growth prospects are supported by the rising burden of cardiovascular diseases and expanding diagnostic infrastructure, competitive pressures, potential generics, and regulatory considerations pose challenges. Companies leveraging innovation, geographic expansion, and strategic partnerships are best positioned to capitalize on emerging opportunities.

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Key Takeaways

• Sustained Demand: The global cardiovascular diagnostics market's growth drives steady demand for regadenoson, especially amid technological advancements.
• Competitive Market: Competition from alternative agents and emerging biosimilars could pressure prices and margins.
• Regional Expansion: Emerging markets present significant growth opportunities, contingent on regulatory approvals and healthcare infrastructure development.
• Innovative Opportunities: Developing new indications and formulations could unlock additional revenue streams.
• Strategic Partnerships: Collaborations with regional distributors and diagnostic providers are critical for expanding market access.

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FAQs

Q1: What factors contribute to regadenoson’s preference over traditional agents like adenosine?
A1: Its selective A2A receptor agonist profile offers rapid onset, shorter duration, and fewer side effects such as bronchospasm, making it more tolerable and easier to administer than traditional agents like adenosine.

Q2: How does the patent landscape affect regadenoson's market?
A2: With the expiration of basic patents, generic manufacturers can enter the market, potentially reducing prices and revenue, while patent protections on formulations or delivery methods can sustain exclusivity.

Q3: What are the primary challenges in expanding regadenoson’s use globally?
A3: Regulatory approval processes, reimbursement policies, competing agents, and limited healthcare infrastructure in some regions pose significant hurdles.

Q4: How might technological innovations impact regadenoson’s market?
A4: Advances in imaging technologies and alternative stress testing methods could diminish reliance on pharmacologic agents, but improvements in regadenoson formulations and expanded indications may sustain demand.

Q5: What is the outlook for regadenoson’s revenue over the next five years?
A5: Revenue is expected to grow modestly at a CAGR of 3–5%, driven by increased diagnostic volumes, geographic expansion, and clinical acceptance, barring significant market disruptors.

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Sources:
[1] Fortune Business Insights, "Cardiovascular Diagnostics Market Size, Share & Industry Analysis," 2021.
[2] IQVIA, "Pharmaceutical Sales Data," 2022.
[3] U.S. Food and Drug Administration, "Regadenoson FDA Approval," 2008.