LEXISCAN Drug Patent Profile

When do Lexiscan patents expire, and when can generic versions of Lexiscan launch?

Lexiscan is a drug marketed by Astellas and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries.

The generic ingredient in LEXISCAN 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 Lexiscan

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

Summary for LEXISCAN

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	47
Patent Applications:	384
Drug Prices:	Drug price information for LEXISCAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEXISCAN
What excipients (inactive ingredients) are in LEXISCAN?	LEXISCAN excipients list
DailyMed Link:	LEXISCAN at DailyMed

See drug prices for LEXISCAN

Recent Clinical Trials for LEXISCAN

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 LEXISCAN clinical trials

Pharmacology for LEXISCAN

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

Paragraph IV (Patent) Challenges for LEXISCAN

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 LEXISCAN

LEXISCAN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	8,106,183			Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	RE47301		Y

Expired US Patents for LEXISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,045,519
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,582,617
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,106,029
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	6,403,567

EU/EMA Drug Approvals for LEXISCAN

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 LEXISCAN

When does loss-of-exclusivity occur for LEXISCAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEXISCAN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1524984	IMAGERIE DE PERFUSION MYOCARDIQUE AU MOYEN D'AGONISTES DE RECEPTEUR A2A (MYOCARDIAL PERFUSION IMAGING USING A2A RECEPTOR AGONISTS)
European Patent Office	1189916	AGONISTES DU RECEPTEUR A 2A N-PYRAZOLE (N-PYRAZOLE A 2A RECEPTOR AGONISTS)
Spain	2593028
Japan	2009525347
European Patent Office	1802317	UTILISATION D'AGONISTES DU RECEPTEUR DE L'ADENOSINE A2A (USE OF A2A ADENOSINE RECEPTOR AGONISTS)

Supplementary Protection Certificates for LEXISCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	SPC004/2011	Ireland		SPC004/2011: 20110719, EXPIRES: 20250620
1189916	C01189916/01	Switzerland		PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916	1190003-2.L	Sweden		PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. 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	SPC/GB11/005	United Kingdom		PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906

LEXISCAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lexiscan (Regadenoson Injection)

Introduction

Lexiscan, also known as regadenoson, is a pharmacologic stress agent used in radionuclide myocardial perfusion imaging (MPI) for patients who are unable to undergo adequate exercise stress. This article delves into the market dynamics and financial trajectory of Lexiscan, highlighting its current market position, financial performance, and future outlook.

Market Position of Lexiscan

Lexiscan is the leading pharmacologic stress agent used in nuclear labs and healthcare systems today. Following the discontinuation of Adenoscan in July 2017, Lexiscan has become the dominant player in this market segment[1].

Market Share

As of 2022, Lexiscan is used by more nuclear labs in healthcare systems, indicating a significant market share. This dominance is attributed to its efficacy and the absence of a major competitor in the pharmacologic stress agent market[1].

Financial Performance

Revenue

The financial performance of Lexiscan is closely tied to its parent company, Astellas Pharma Inc. According to IQVIA, the U.S. sales for Lexiscan were approximately $650 million for the 12 months ending March 31, 2022. This figure highlights the substantial revenue generated by Lexiscan in the U.S. market alone[4].

Parent Company Performance

Astellas Pharma Inc. reported a revenue increase of 17.2% year-over-year (YoY) in FY2022, reaching JPY1,518.6 billion. This growth was driven by the performance of key products, including Lexiscan, XTANDI, XOSPATA, and PADCEV. The core operating profit also increased by 17.2% YoY, reflecting the company's overall financial health[2].

Cost Structure and Efficiency

Economic Model

Astellas offers an economic model to assess the financial impact of varying procedures in radionuclide MPI processes. This model helps healthcare institutions evaluate the cost-effectiveness of using Lexiscan, which can be presented to formulary committees to make informed decisions[1].

Operational Excellence

Astellas is committed to operational excellence, which includes optimizing cost structures and improving efficiency. These initiatives are expected to contribute to maintaining a high core operating profit margin in the future, with targets set at 25% for FY2024 and 30% for FY2025[2].

Safety and Efficacy

Adverse Reactions

While Lexiscan is effective, it comes with potential risks. Adverse reactions include myocardial ischemia, ventricular arrhythmias, cardiac arrest, and hypersensitivity reactions such as anaphylaxis. These risks are critical considerations for healthcare providers and patients[1].

Respiratory Adverse Effects

Lexiscan can cause respiratory adverse effects, particularly in patients with asthma or chronic obstructive pulmonary disease (COPD). These effects include dyspnea, wheezing, and reductions in FEV1. However, most patients continue their prescribed respiratory medications without significant issues[1].

Competitive Landscape

Discontinuation of Adenoscan

The discontinuation of Adenoscan in July 2017 has left Lexiscan as the primary pharmacologic stress agent in the market. This absence of a major competitor has solidified Lexiscan's market position[1].

Generic and Proprietary Products

Amphastar, a bio-pharmaceutical company, received FDA approval for its generic version of regadenoson. However, the commercialization timeline is subject to confidential settlement terms, which may impact the competitive landscape in the future[4].

Future Outlook

Market Growth

The demand for pharmacologic stress agents is expected to continue, driven by the need for diagnostic imaging in cardiovascular diseases. Lexiscan's position as a leading agent in this market segment positions it for sustained growth.

Financial Projections

Astellas is forecasting continued revenue growth, albeit with some challenges due to foreign exchange rates. The company aims to maintain its core operating profit margin through operational excellence and strategic investments in key products, including Lexiscan[2].

Regulatory Environment

FDA Approvals

The FDA approval of generic versions of regadenoson, such as Amphastar's product, could potentially impact the market dynamics. However, the timing and terms of these approvals will be crucial in determining the competitive landscape[4].

Conclusion

Lexiscan's market dynamics are characterized by its dominant position in the pharmacologic stress agent market, driven by the discontinuation of Adenoscan and its own efficacy. Financially, Lexiscan contributes significantly to Astellas Pharma Inc.'s revenue and profit growth. The company's focus on operational excellence and strategic investments is expected to maintain Lexiscan's market position and financial performance in the future.

Key Takeaways

• Market Dominance: Lexiscan is the leading pharmacologic stress agent used in nuclear labs and healthcare systems.
• Financial Performance: Lexiscan generated approximately $650 million in U.S. sales for the 12 months ending March 31, 2022.
• Safety and Efficacy: Lexiscan is effective but comes with potential risks such as myocardial ischemia and hypersensitivity reactions.
• Competitive Landscape: The discontinuation of Adenoscan has solidified Lexiscan's market position.
• Future Outlook: Continued demand for diagnostic imaging and Astellas' strategic investments are expected to sustain Lexiscan's growth.

FAQs

What is Lexiscan used for?

Lexiscan is used for radionuclide myocardial perfusion imaging (MPI) in patients who are unable to undergo adequate exercise stress.

What are the potential risks associated with Lexiscan?

Potential risks include myocardial ischemia, ventricular arrhythmias, cardiac arrest, and hypersensitivity reactions such as anaphylaxis.

How much revenue did Lexiscan generate in the U.S. in 2022?

Lexiscan generated approximately $650 million in U.S. sales for the 12 months ending March 31, 2022.

What is the current market position of Lexiscan?

Lexiscan is the leading pharmacologic stress agent used in nuclear labs and healthcare systems today.

Who are the key players in the market for pharmacologic stress agents?

Astellas Pharma Inc. is the primary player with Lexiscan, while Amphastar has received FDA approval for a generic version of regadenoson.

Sources

1. Lexiscan Pharmacologic Stress Market Share - Lexiscan
2. Astellas Pharma Inc. FY2022 Financial Results - Astellas
3. Drug Expenditure Dynamics 1995-2020 - IQVIA
4. Amphastar Receives FDA Approval for Regadenoson - Amphastar