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DEFINITY Drug Patent Profile

Which patents cover Definity, and what generic alternatives are available?

Definity 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 is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

DrugPatentWatch^® Generic Entry Outlook for Definity

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFINITY

International Patents:	72
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	65
Patent Applications:	2,797
Drug Prices:	Drug price information for DEFINITY
What excipients (inactive ingredients) are in DEFINITY?	DEFINITY excipients list
DailyMed Link:	DEFINITY at DailyMed

See drug prices for DEFINITY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEFINITY

Constraining patent/regulatory exclusivity:

5,527,521

NDA:

021064

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DEFINITY

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

Sponsor	Phase
Sunnybrook Health Sciences Centre	Phase 2
Terry Fox Research Institute	Phase 2
InSightec	Phase 2

See all DEFINITY clinical trials

Pharmacology for DEFINITY

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

US Patents and Regulatory Information for DEFINITY

DEFINITY is protected by eight US patents.

This potential generic entry date is based on patent 5,527,521.

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

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	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	9,789,210
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,022,460		Y	Y
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	11,857,646
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	10,583,208
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,583,207
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	11,266,750
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,857,646

Expired US Patents for DEFINITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	8,685,441
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,033,645
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	8,658,205
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	5,527,521
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,528,039
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	9,545,457
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,146,657

EU/EMA Drug Approvals for DEFINITY

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

See the table below for patents covering DEFINITY 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
Austria	227960

Supplementary Protection Certificates for DEFINITY

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
0712293	CA 2007 00027	Denmark

DEFINITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DEFINITY

Introduction

DEFINITY, also known as Perflutren Lipid Microsphere, is a diagnostic ultrasound enhancing agent used in patients with suboptimal echocardiograms. Here, we will delve into the market dynamics and financial trajectory of DEFINITY, focusing on its production, market performance, and future outlook.

Market Overview

DEFINITY is produced by Lantheus Holdings, Inc., a company specialized in innovative imaging diagnostics, targeted therapeutics, and artificial intelligence solutions. The drug has been a significant player in the diagnostic imaging market, particularly for patients requiring enhanced echocardiograms.

Regulatory Approvals and Manufacturing

A crucial milestone for DEFINITY was the approval of Lantheus' isolator-based drug manufacturing facility by the U.S. FDA in February 2022. This approval enhanced the security of DEFINITY's supply chain and provided the company with supply chain redundancy and potential margin expansion[4].

Market Expansion and Competition

The market for DEFINITY is subject to several dynamics, including competition and regulatory factors. Lantheus aims to continue expanding the market penetration of DEFINITY despite potential generic competition and the expiration of patent and regulatory exclusivity. The company's ability to manufacture DEFINITY at its new facility is critical in maintaining market share[4].

Financial Performance

Lantheus' financial performance is closely tied to the success of DEFINITY. Here are some key financial indicators:

Revenue and Growth

While specific revenue figures for DEFINITY are not provided in the sources, the overall financial health of Lantheus is indicative of the drug's performance. The company's strategy to improve supply chain security and expand market penetration suggests a positive financial trajectory.

Supply Chain and Cost Management

The approval of the new manufacturing facility is expected to enhance Lantheus' financial position by reducing costs and increasing efficiency. This facility will allow the company to include DEFINITY inventory from this site into its supply chain, potentially leading to margin expansion[4].

Risks and Uncertainties

Several risks and uncertainties could impact the financial trajectory of DEFINITY:

Competitive Landscape

The diagnostic imaging market is competitive, and DEFINITY faces potential generic competition. The expiration of patent and regulatory exclusivity could further intensify competition[4].

Regulatory Changes

Changes in FDA classifications or regulations could affect the product's status, potentially reclassifying it from a drug to a device. This could introduce additional complexity and reduce competitive protection[4].

Economic Factors

The COVID-19 pandemic has had a broad impact on the healthcare industry, and ongoing economic uncertainties could affect the demand for diagnostic imaging agents like DEFINITY[4].

Future Outlook

Despite the challenges, Lantheus remains optimistic about the future of DEFINITY. Here are some key points:

Market Penetration

The company is committed to continuing market expansion and penetration for DEFINITY. This involves leveraging the new manufacturing facility to ensure a stable supply and exploring new markets and distribution channels[4].

Intellectual Property Protection

Protecting the intellectual property of DEFINITY is crucial for maintaining its market position. Lantheus is focused on ensuring that the drug remains protected against potential generic competition[4].

Key Takeaways

• Regulatory Approvals: The FDA approval of the new manufacturing facility is a significant milestone for DEFINITY.
• Market Expansion: Lantheus is focused on expanding market penetration despite competitive and regulatory challenges.
• Financial Performance: The new facility is expected to enhance financial performance through cost reduction and margin expansion.
• Risks and Uncertainties: The company faces risks related to competition, regulatory changes, and economic factors.

FAQs

Q1: What is DEFINITY used for? DEFINITY, or Perflutren Lipid Microsphere, is used as an ultrasound enhancing agent for patients with suboptimal echocardiograms.

Q2: Who manufactures DEFINITY? DEFINITY is manufactured by Lantheus Holdings, Inc.

Q3: What was the significance of the FDA approval for Lantheus' manufacturing facility? The FDA approval of the isolator-based drug manufacturing facility enhanced the security of DEFINITY's supply chain, provided supply chain redundancy, and offered potential margin expansion.

Q4: What are the main risks facing DEFINITY in the market? The main risks include competition from generic alternatives, regulatory changes, and economic uncertainties such as the impact of the COVID-19 pandemic.

Q5: How does Lantheus plan to maintain market share for DEFINITY? Lantheus plans to continue market expansion, protect intellectual property, and leverage the new manufacturing facility to ensure a stable supply and reduce costs.

Sources

1. Lantheus Receives U.S. FDA Approval of New Manufacturing Facility - GlobeNewswire
2. Definity Financial Corporation 2023 Annual Report - Definity Financial Corporation
3. MARKET REVIEW - SMB Trust Services
4. Lantheus Receives U.S. FDA Approval of New Manufacturing Facility - Lantheus Holdings, Inc.
5. Definity Financial Corporation Reports Fourth Quarter and Full Year 2023 Results - Definity Financial Corporation