REGADENOSON Drug Patent Profile

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

Regadenoson is a drug marketed by 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 thirteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Regadenoson

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

Summary for REGADENOSON

US Patents:	0
Applicants:	13
NDAs:	13
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	61
Patent Applications:	518
Drug Prices:	Drug price information for REGADENOSON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REGADENOSON
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
Siemens Medical Solutions	N/A

See all REGADENOSON clinical trials

Pharmacology for REGADENOSON

Drug Class	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
Accord Hlthcare	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213236-001	Apr 11, 2022	AP	RX	No	No
Gland	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207320-001	Jul 12, 2022	AP	RX	No	No
Dr Reddys	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213210-001	Apr 11, 2022	AP	RX	No	No
Meitheal	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	212806-001	Apr 11, 2022	AP	RX	No	No
Hikma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	215827-001	Feb 2, 2023	AP	RX	No	No
Apotex	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207604-001	Apr 11, 2022	AP	RX	No	No
Baxter Hlthcare Corp	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	217455-001	May 23, 2023	AP	RX	No	No

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

REGADENOSON Market Analysis and Financial Projection

Last updated: February 6, 2026

What are the market dynamics for Regadenoson?

Regadenoson is a selective adenosine A2A receptor agonist primarily used as a pharmacologic stress agent in myocardial perfusion imaging. It gained FDA approval in 2008 for this application. The global demand for stress testing agents is driven by increasing cardiovascular disease prevalence, advances in cardiac imaging technology, and rising adoption of non-invasive diagnostic procedures.

Market Demand Drivers

• Growing Cardiovascular Disease Incidence: As heart disease remains the leading cause of death globally, the need for efficient diagnostics increases. According to the World Health Organization, cardiovascular diseases account for approximately 17.9 million deaths annually.
• Preference for Non-Invasive Testing: Medical guidelines increasingly favor stress imaging over invasive procedures, bolstering the demand for agents like regadenoson.
• Advancements in Imaging Technology: Improvements in SPECT and PET imaging systems bolster the utility of pharmacologic stress agents, including regadenoson.

Competitive Landscape

Regadenoson competes mainly with adenosine and dipyridamole, which are older agents. However, regadenoson’s simplified administration (single bolus dose) provides a competitive advantage over adenosine, requiring less infusion time.

Market Penetration

• Geographical Distribution: North America dominates the market, leveraging well-established cardiac imaging infrastructure and regulatory approval. Europe follows, with increasing adoption due to expanding healthcare budgets and awareness.
• Hospital and Clinic Settings: The majority of regadenoson use occurs in hospital-based imaging centers.

Market Challenges

• Pricing Pressures: Regulatory and health system pressures result in cost scrutiny, impacting revenue streams.
• Limited Indications: Regulatory approval is mainly for myocardial perfusion imaging, constraining broader clinical applications.
• Competition from Emerging Technologies: Advances in MRI and other imaging modalities threaten to reduce reliance on pharmacologic stress agents.

What is the financial trajectory for regadenoson?

The financial outlook for regadenoson hinges on sales volume, pricing strategies, and competitive pressures within the cardiac imaging market.

Revenue Estimates

• Global Sales: In 2021, the drug's estimated sales ranged between $200 million and $300 million, primarily in North America.
• Market Share: Regadenoson holds an estimated 60%-70% share of the pharmacologic stress agent market, with adenosine's usage declining due to administration complexities.
• Pricing: Per-dose pricing varies but averages approximately $300-$400 per injection in the U.S.

Growth Projections

• Compound Annual Growth Rate (CAGR): Analyst estimates project a CAGR of 4-6% for the regadenoson market from 2022 to 2030, driven by increasing cardiac diagnostics volume and expanding indications.
• Pipeline Influence: Development of newer agents or alternative imaging techniques could dampen growth prospects.

Regulatory and Reimbursement Factors

• Regulatory Approvals: Additional approvals for broader indications in cardiac imaging or other diagnostic areas could boost sales.
• Insurance Coverage: Positive coverage policies in major markets will support utilization and revenue.

Patent and Intellectual Property Considerations

Regadenoson's original patent expired in 2017, allowing potential generic competition. Ongoing patent litigations and exclusivity extensions could influence future pricing and sales.

Investment and R&D Outlook

Pharmaceutical companies are investing in combination imaging agents and alternative stress testing methods, which may erode regadenoson’s market share long-term.

Summary of Key Market and Financial Data

Aspect	Details
Market Size (2021)	$200-$300 million (global)
Market Share	60%-70% within pharmacologic stress agents
Main Competitive Agents	Adenosine, dipyridamole
Growth Rate (2022-2030)	4%-6% CAGR
Price per Dose	$300-$400 (U.S.)
Regulatory Status	FDA-approved for myocardial perfusion imaging

What are the implications for stakeholders?

• Pharma companies: Focus on expanding indications and geographic markets.
• Investors: Monitor competitive developments, patent status, and reimbursement trends.
• Healthcare providers: Evaluate cost-effectiveness amid emerging imaging alternatives.

Key Takeaways

• Regadenoson addresses a growing need for non-invasive cardiac stress testing.
• Its market is concentrated mainly in North America, with moderate growth prospects.
• Competition from advanced imaging technologies and generic products may pressure revenues.
• Regulatory and reimbursement policies significantly influence its sales trajectory.
• Investment in R&D for broader indications or next-generation agents could alter its market position.

FAQs

1. When was regadenoson FDA-approved?
It received FDA approval in 2008 for myocardial perfusion imaging.

2. What are the primary competitors of regadenoson?
Adenosine and dipyridamole are the main competitors, with adenosine being older but less user-friendly.

3. What factors are driving growth in the regadenoson market?
Increasing cardiovascular disease prevalence, preference for non-invasive diagnostics, and technological advances in cardiac imaging.

4. How does regulatory status impact regadenoson sales?
New approvals and positive reimbursement policies expand market access, whereas restrictions or delays limit growth.

5. What risks could affect regadenoson’s future financial performance?
Emergence of new imaging modalities, patent expirations leading to generic competition, and regulatory constraints.

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Sources

1. World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
2. MarketWatch. Regadenoson Market Size and Trends. 2022.
3. FDA. Regulatory history of regadenoson.
4. EvaluatePharma. Oncology and Cardiology drug market insights. 2022.
5. IQVIA. Healthcare Market Reports. 2022.