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 Pharma Ltd, 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. Fifteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	60
Patent Applications:	384
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
St. Jude Children's Research Hospital	Phase 2
Emory University	N/A
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 Pharma Ltd	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

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

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