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DEFINITY RT Drug Patent Profile

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

Definity Rt is a drug marketed by Lantheus Medcl and is included in one NDA. There are ten patents protecting this drug.

This drug has seventy-two patent family members in seventeen countries.

The generic ingredient in DEFINITY RT is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

DrugPatentWatch^® Generic Entry Outlook for Definity Rt

Definity Rt was eligible for patent challenges on July 31, 2005.

Indicators of Generic Entry

Summary for DEFINITY RT

International Patents:	72
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	65
Drug Prices:	Drug price information for DEFINITY RT
What excipients (inactive ingredients) are in DEFINITY RT?	DEFINITY RT excipients list
DailyMed Link:	DEFINITY RT at DailyMed

See drug prices for DEFINITY RT

Recent Clinical Trials for DEFINITY RT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sunnybrook Health Sciences Centre	Phase 2
Terry Fox Research Institute	Phase 2
M.D. Anderson Cancer Center	Phase 2

See all DEFINITY RT clinical trials

Pharmacology for DEFINITY RT

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

US Patents and Regulatory Information for DEFINITY RT

DEFINITY RT is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,583,208
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,395,856		Y	Y
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,583,207
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,857,646
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,588,988
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	9,789,210

EU/EMA Drug Approvals for DEFINITY RT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Lantheus EU Limited	Luminity	perflutren	EMEA/H/C/000654 This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.	Authorised	no	no	no	2006-09-20
GE Healthcare AS	Optison	perflutren	EMEA/H/C/000166 This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.	Authorised	no	no	no	1998-05-17

International Patents for DEFINITY RT

See the table below for patents covering DEFINITY RT around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69629478
Australia	7043194
World Intellectual Property Organization (WIPO)	9222298
Japan	5160702
European Patent Office	0852477
Germany	69233119

Supplementary Protection Certificates for DEFINITY RT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	SPC018/2007	Ireland		SPC018/2007: 20071012, EXPIRES: 20190519
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	91325	Luxembourg		PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920

DEFINITY RT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DEFINITY RT

Introduction to DEFINITY RT

DEFINITY RT, a modified formulation of the ultrasound contrast agent DEFINITY, was approved by the U.S. Food and Drug Administration (FDA) in November 2020. This new formulation allows for storage and shipment at room temperature, marking a significant advancement in the delivery of healthcare services[1].

Market Position and Share

Lantheus Holdings, the parent company of Lantheus Medical Imaging, holds a dominant position in the ultrasound contrast imaging market. DEFINITY, the predecessor to DEFINITY RT, has an extensive market presence, with approximately 80% market share in the U.S. ultrasound contrast imaging agent market. This strong market share is a testament to the trust and reliability that clinicians and patients have in Lantheus's microbubble products[3].

Clinical Utility and Adoption

DEFINITY RT is designed to enhance suboptimal echocardiograms, a critical application in cardiac imaging. The ability to store and ship this formulation at room temperature increases its portability and utility in various clinical settings. This flexibility is particularly beneficial in scenarios where refrigeration may not be readily available, thereby expanding the reach of this diagnostic tool[1].

Financial Impact

The approval and launch of DEFINITY RT are expected to contribute positively to Lantheus Holdings' financial performance. Here are some key financial aspects:

Revenue Growth

• The introduction of DEFINITY RT is part of Lantheus's strategy to sustain and accelerate revenue growth. Given the strong market share of DEFINITY, the new formulation is likely to maintain or even increase market penetration, contributing to revenue growth[3].

Cost Savings and Efficiency

• The room temperature formulation reduces logistical complexities and costs associated with refrigerated storage and transportation. This can lead to operational efficiencies and cost savings, which can be reinvested in research and development or other business areas[1].

Market Expansion

• With its enhanced portability, DEFINITY RT can be used in a broader range of clinical settings, including those in remote or underserved areas. This expansion can lead to increased sales and market share, further solidifying Lantheus's position in the diagnostic imaging market[1].

Competitive Landscape

Market Dominance

• Lantheus's dominance in the ultrasound contrast imaging market, coupled with the innovative features of DEFINITY RT, positions the company to maintain its market leadership. The company's extensive experience and consistent safety profile of DEFINITY since its launch in 2001 also contribute to its competitive edge[1].

Strategic Focus

• Lantheus's strategic focus on expanding its microbubble franchise and diversifying its product portfolio ensures that the company remains competitive. The combination of DEFINITY RT with other diagnostic and therapeutic agents under Lantheus's umbrella enhances its overall market presence and financial stability[3].

Financial Performance Indicators

Revenue Streams

• Lantheus Holdings generates significant revenue from its ultrasound contrast imaging agents, with DEFINITY being a major contributor. The introduction of DEFINITY RT is expected to bolster this revenue stream, contributing to the company's overall financial health[3].

Operating Margins

• The operational efficiencies and cost savings from the room temperature formulation can lead to improved operating margins. This, combined with the company's disciplined approach to spending, positions Lantheus for sustained profitability[3].

Growth Projections

• Lantheus aims to achieve profitable double-digit revenue growth, and the launch of DEFINITY RT aligns with this goal. The company's financial projections indicate continued strength in underwriting profitability and expansions in investment and distribution income, supporting an increase in operating return on equity (ROE)[3].

Industry Trends and Challenges

Regulatory Environment

• The FDA approval process and ongoing regulatory requirements are crucial for the success of DEFINITY RT. Lantheus's experience in navigating these regulatory pathways ensures compliance and continued market access[1].

Technological Advancements

• The healthcare industry is witnessing rapid technological advancements, including improvements in diagnostic imaging. Lantheus's commitment to innovation, such as the use of the VIALMIX RFID device for activating DEFINITY RT, keeps the company at the forefront of these advancements[1].

Market Dynamics

• The pharmaceutical and diagnostic imaging markets are subject to various dynamics, including changes in healthcare spending and the impact of generic drugs. However, DEFINITY RT's unique formulation and clinical utility mitigate some of these risks, ensuring a stable market position[4].

Key Takeaways

• Market Leadership: DEFINITY RT solidifies Lantheus Holdings' position as a leader in the ultrasound contrast imaging market.
• Operational Efficiencies: The room temperature formulation reduces logistical costs and enhances portability.
• Revenue Growth: Expected to contribute positively to Lantheus's revenue streams and overall financial performance.
• Competitive Edge: Enhanced by the company's extensive experience, consistent safety profile, and strategic focus on innovation.
• Financial Projections: Aligns with Lantheus's goals of achieving profitable double-digit revenue growth and improving operating margins.

FAQs

Q: What is DEFINITY RT, and how does it differ from the original DEFINITY?

A: DEFINITY RT is a modified formulation of DEFINITY that allows for storage and shipment at room temperature, unlike the original DEFINITY which requires refrigeration.

Q: What are the clinical benefits of DEFINITY RT?

A: DEFINITY RT enhances suboptimal echocardiograms and offers greater utility in broader clinical settings due to its room temperature storage capability.

Q: How does the approval of DEFINITY RT impact Lantheus Holdings' financial performance?

A: The approval is expected to contribute to revenue growth, operational efficiencies, and cost savings, all of which positively impact Lantheus Holdings' financial performance.

Q: What is the market share of DEFINITY in the ultrasound contrast imaging market?

A: DEFINITY holds approximately 80% market share in the U.S. ultrasound contrast imaging agent market.

Q: How does the regulatory environment affect the launch and maintenance of DEFINITY RT in the market?

A: FDA approval and ongoing compliance with regulatory requirements are crucial for the success of DEFINITY RT, and Lantheus's experience in this area ensures continued market access.

Sources:

1. Lantheus Holdings Announces FDA Approval of DEFINITY Room Temperature - Company Press Release.
2. Definity Financial Corporation 2023 Annual Report - Definity Financial Corporation.
3. Lantheus Holdings Investor Presentation - Lantheus Holdings.
4. Cost of Generic Drug Development and Approval - Office of the Assistant Secretary for Planning and Evaluation.