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 Pharma Ltd, 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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	60
Patent Applications:	713
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
St. Jude Children's Research Hospital	Phase 2
Siemens Medical Solutions	N/A
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
Mylan	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213856-001	Apr 4, 2023	AP	RX	No	No
Meitheal	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	212806-001	Apr 11, 2022	AP	RX	No	No
Apotex	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207604-001	Apr 11, 2022	AP	RX	No	No
Indies Pharma	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054-001	Aug 22, 2024	AP	RX	No	No
Baxter Hlthcare Corp	REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	217455-001	May 23, 2023	AP	RX	No	No
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes				Y

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

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/001176 This 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)
Spain	2593028
South Korea	101494125
Norway	341322
Japan	2013010791	PROCESS FOR PREPARING A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS
Russian Federation	2447081	СПОСОБ ПОЛУЧЕНИЯ АГОНИСТА A2A-АДЕНОЗИНОВОГО РЕЦЕПТОРА И ЕГО ПОЛИМОРФОВ (METHOD OF PRODUCING A2A-ADENOSINE RECEPTOR AGONIST AND POLYMORPHS THEREOF)

Supplementary Protection Certificates for regadenoson

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	11C0004	France		PRODUCT NAME: REGADENOSON ET SES SELS; 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
1189916	C300477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	SZ 2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916	2011C/004	Belgium		PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916	1190003-2.L	Sweden		PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906

Regadenoson Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Regadenoson

Introduction

Regadenoson, marketed under the brand name Lexiscan, is a small molecule drug that has revolutionized the field of cardiovascular diagnostics, particularly in radionuclide myocardial perfusion imaging (MPI). Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Mechanism and Therapeutic Use

Regadenoson is an adenosine A2a receptor agonist, designed to dilate the arteries of the heart and increase blood flow. This action helps in identifying coronary artery disease, especially in patients who are unable to undergo adequate exercise stress[3][5].

Approval and Regulatory Milestones

Regadenoson was first approved by the FDA in April 2008 for use in the United States. This approval marked a significant milestone in the drug's journey, paving the way for its global market entry. The drug has since been approved in various countries for indications including coronary angiography and myocardial ischemia[2][3].

Market Share and Growth

Following its FDA approval, regadenoson saw a steady increase in market share. By November 2008, just a few months after its approval, the drug's market share had risen from 2% in July 2008 to 11%. This rapid growth underscores the drug's efficacy and the demand for pharmacologic stress agents in cardiovascular diagnostics[4].

Competitive Landscape

The market for pharmacologic stress agents is competitive, with regadenoson competing against other adenosine receptor agonists. However, its selective action on the A2a receptor and its proven safety profile have helped it maintain a strong position. The drug's ability to induce maximal hyperemia without the need for exercise stress has made it a preferred choice in many clinical settings[3][4].

Financial Performance

The financial performance of regadenoson has been robust, driven by its increasing adoption in clinical practice. According to market data, the sales of regadenoson have consistently grown since its approval. For instance, Amphastar Pharmaceuticals, which received FDA approval for its generic version of regadenoson in 2022, anticipates significant revenue from this product, given its market size and growth potential[1].

Pricing and Reimbursement

The pricing of regadenoson can vary based on the region and the specific formulation. However, it is generally priced competitively with other pharmacologic stress agents. Reimbursement policies also play a crucial role in the drug's financial trajectory. In many healthcare systems, regadenoson is covered under insurance plans, which helps in driving its adoption and revenue[5].

Clinical Trials and Research

Continuous research and clinical trials have been instrumental in expanding the therapeutic indications of regadenoson. Studies have explored its use in various cardiovascular conditions, including coronary artery disease, myocardial ischemia, and even in patients with chronic obstructive pulmonary disease (COPD) and asthma. These trials have not only enhanced the drug's safety profile but also opened up new market opportunities[2][4].

Side Effects and Safety Profile

While regadenoson is generally well-tolerated, it does come with some side effects, such as headache, dizziness, and increased heart rate. However, these side effects are typically transient and manageable. The safety profile of regadenoson has been extensively studied, and it has been found to be safe for use in a wide range of patients, including those with mild to moderate asthma and COPD[5].

Market Expansion and Global Reach

Regadenoson has achieved significant global reach since its approval. It is used in various countries for different indications related to cardiovascular health. The drug's global market presence is a testament to its therapeutic value and the demand for effective pharmacologic stress agents worldwide[2][3].

Future Outlook

The future outlook for regadenoson remains promising. With ongoing research and clinical trials, there is potential for expanding its therapeutic indications further. Additionally, the increasing prevalence of cardiovascular diseases globally is expected to drive the demand for diagnostic tools like regadenoson. As more generic versions enter the market, competition may increase, but the drug's established reputation and efficacy are likely to sustain its market position[1][3].

Key Takeaways

• Mechanism and Use: Regadenoson is an adenosine A2a receptor agonist used for radionuclide myocardial perfusion imaging.
• Approval and Growth: First approved in 2008, the drug has seen steady market share growth.
• Financial Performance: Robust sales driven by clinical adoption and market demand.
• Competitive Landscape: Strong position due to its selective action and safety profile.
• Clinical Trials: Ongoing research expanding its therapeutic indications.
• Safety Profile: Generally well-tolerated with manageable side effects.
• Global Reach: Used in various countries for cardiovascular diagnostics.

FAQs

What is regadenoson used for?

Regadenoson is used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Who developed regadenoson?

Regadenoson was developed by Astellas Pharma, Inc.[3].

When was regadenoson first approved?

Regadenoson was first approved by the FDA in April 2008[2][3].

What are the common side effects of regadenoson?

Common side effects include headache, dizziness, and increased heart rate. Less common side effects include change in taste, loss of taste, and stomach soreness[5].

Is regadenoson safe for patients with respiratory conditions?

Regadenoson has been found to be safe for use in patients with mild to moderate asthma and chronic obstructive pulmonary disease (COPD)[5].

What is the market outlook for regadenoson?

The market outlook for regadenoson is promising, driven by increasing demand for cardiovascular diagnostics and ongoing research expanding its therapeutic indications.

Sources

1. Amphastar Receives FDA Approval for Regadenoson - Accesswire
2. Regadenoson - Synapse - Global Drug Intelligence Database - Synapse
3. Regadenoson: Detailed Review of its Transformative R&D Success - Synapse
4. Regadenoson: A New Myocardial Stress Agent - ScienceDirect
5. Regadenoson (intravenous route) - Mayo Clinic