Regadenoson - Generic Drug Details

What are the generic drug sources for regadenoson and what is the scope of freedom to operate?

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. Seventeen 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:	17
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
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	8,106,183			Y
Indies Pharma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054-001	Aug 22, 2024	AP	RX	No	No
Gland	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207320-001	Jul 12, 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
Ims Ltd	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	214252-001	May 23, 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	RE47351
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,470,801
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	6,403,567
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,536,150
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,655,636
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,106,029

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
South Korea	101494125
Spain	2593028
Japan	2009525347
World Intellectual Property Organization (WIPO)	2007092372
China	102260311
South Africa	200806666	Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Slovenia	1989214

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	2011C/004	Belgium		PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916	C01189916/01	Switzerland		PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	11C0004	France		PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: 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
1189916	SPC/GB11/005	United Kingdom		PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906

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.