Perflutren - Generic Drug Details

What are the generic drug sources for perflutren and what is the scope of freedom to operate?

Perflutren is the generic ingredient in two branded drugs marketed by Lantheus Medcl and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Perflutren has seventy-two patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for perflutren

International Patents:	72
US Patents:	10
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	26
Patent Applications:	5,934
What excipients (inactive ingredients) are in perflutren?	perflutren excipients list
DailyMed Link:	perflutren at DailyMed

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

Constraining patent/regulatory exclusivity:

5,527,521

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 perflutren

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

Sponsor	Phase
Thomas Jefferson University	Phase 3
Thomas Jefferson University	Phase 2
UNC Lineberger Comprehensive Cancer Center	Phase 2

See all perflutren clinical trials

Pharmacology for perflutren

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

US Patents and Regulatory Information for perflutren

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	11,395,856		Y	Y
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,529,431
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	11,925,695
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	11,925,695

Expired US Patents for perflutren

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

EU/EMA Drug Approvals for perflutren

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 perflutren

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017192910
Hong Kong	1244677	脂質封裝的氣體微球組合物及相關方法 (LIPID-ENCAPSULATED GAS MICROSPHERE COMPOSITIONS AND RELATED METHODS)
Canada	3022698	METHODES ET DISPOSITIFS DE PREPARATION D'AGENTS DE CONTRASTE ULTRASONORES (METHODS AND DEVICES FOR PREPARATION OF ULTRASOUND CONTRAST AGENTS)
South Korea	102500959
Spain	2928401
Brazil	112017013787	composições de microesfera de gás lipídio-encapsulado e métodos relacionados

Supplementary Protection Certificates for perflutren

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920

Perflutren Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Perflutren

Introduction to Perflutren

Perflutren, marketed under brand names such as DEFINITY and Optison, is a diagnostic medication used to enhance contrast during echocardiograms. It consists of lipid-coated microspheres filled with octafluoropropane (OFP) gas, which resonate when exposed to ultrasound waves, improving the visibility of the heart's inner edges and borders[4].

Market Size and Growth of Contrast Media

The global contrast media market, which includes perflutren, is projected to grow significantly. By 2024, the market size is estimated to reach USD 5.77 billion, with a Compound Annual Growth Rate (CAGR) of 7.44% expected to reach USD 6.59 billion by 2029[3].

Segment Growth Drivers

Several factors drive the growth of the contrast media market, including:

• Increasing Incidence of Chronic Diseases: The rising prevalence of heart and circulatory diseases, as well as other chronic conditions, increases the demand for diagnostic imaging procedures. For instance, around 7.6 million people in the UK live with heart and circulatory diseases, driving the need for enhanced diagnostic tools[3].

• Advancements in Imaging Techniques: Clinical advancements in iodinated contrast media, which are non-ionic, have low osmolality, and are highly safe, contribute to the segment's revenue growth. Strategic alliances among key market players, such as GE Healthcare's agreement to ensure iodine availability for X-ray and CT procedures, also propel market growth[3].

• Regulatory Approvals: Recent approvals, such as the FDA's approval of DEFINITY for use in pediatric patients with suboptimal echocardiograms, further expand the market[3].

Regional Market Dynamics

North America

North America is expected to contribute significantly to the market's growth due to the rising prevalence of long-term diseases and increasing healthcare expenditures. The region's high incidence of cancer, such as liver cancer, which saw 41,630 new diagnoses in the US in 2023, drives the demand for contrast media for diagnostic purposes[3].

Asia-Pacific

The Asia-Pacific region is identified as the fastest-growing market for contrast media. This growth is driven by a significant patient population that has yet to fully utilize contrast-enhanced imaging, creating substantial growth opportunities for manufacturers[3].

Financial Performance of Lantheus Holdings Inc.

Lantheus Holdings Inc., the company behind DEFINITY, has shown steady financial growth:

• Revenue Growth: In the first quarter of 2019, Lantheus reported worldwide revenues of $86.5 million, a 4.7% increase from the first quarter of 2018. The full-year 2018 revenues were $343.4 million, up 3.6% from 2017[2][5].

• Product-Specific Revenue: DEFINITY specifically saw a 14.5% revenue increase in the first quarter of 2019 compared to the same period in 2018, with revenues of $51.1 million[2].

• Net Income and Adjusted EPS: The company reported a net income of $9.9 million in the first quarter of 2019, with an adjusted net income per share of $0.28. This indicates a stable financial performance and growth in profitability[2].

Operational and Research Expenses

Lantheus Holdings Inc. has been investing in research and development, as well as sales and marketing efforts:

• Research and Development: The company spent $4.9 million on research and development in the first quarter of 2019, an increase from $3.9 million in the same period of 2018[2].

• Sales and Marketing: Sales and marketing expenses were $10.4 million in the first quarter of 2019, slightly down from $10.6 million in the first quarter of 2018[2].

Strategic Developments and Approvals

Recent strategic developments and regulatory approvals have been crucial for the market trajectory of perflutren:

• Pediatric Approval: The FDA's approval of DEFINITY for use in pediatric patients with suboptimal echocardiograms in March 2024 expands the product's market reach[3].

• Generic Contrast Media: The launch of generic contrast media agents, such as Fresenius Kabi's Iodixanol Injection in the US, indicates a competitive but growing market environment[3].

Key Takeaways

• The global contrast media market, including perflutren, is expected to grow significantly, driven by increasing chronic disease incidence and advancements in imaging techniques.
• North America and the Asia-Pacific region are key markets, with North America contributing significantly due to high disease prevalence and healthcare expenditures.
• Lantheus Holdings Inc. has shown steady revenue growth and investment in research and development, indicating a strong financial trajectory for DEFINITY.
• Recent regulatory approvals and strategic alliances are expected to further drive market growth.

FAQs

What is the primary use of perflutren in medical diagnostics?

Perflutren is used as an ultrasound contrast agent to enhance the visibility of the heart's inner edges and borders during echocardiograms[4].

How is the global contrast media market expected to grow?

The global contrast media market is expected to reach USD 5.77 billion by 2024 and grow at a CAGR of 7.44% to reach USD 6.59 billion by 2029[3].

Which regions are driving the growth of the contrast media market?

North America is expected to contribute significantly, while the Asia-Pacific region is identified as the fastest-growing market[3].

What was the revenue growth for Lantheus Holdings Inc. in the first quarter of 2019?

Lantheus Holdings Inc. reported a 4.7% increase in worldwide revenues to $86.5 million in the first quarter of 2019 compared to the same period in 2018[2].

What recent regulatory approval has impacted the market for DEFINITY?

The FDA approved DEFINITY for use in pediatric patients with suboptimal echocardiograms in March 2024, expanding its market reach[3].

Sources

1. The History of Product Label Changes for DEFINITY® in the US - USC Journal
2. Lantheus Holdings, Inc. Reports First Quarter 2019 Financial Results - Lantheus Holdings Inc.
3. Contrast Media Market Report: Size, Share, Growth Analysis - Mordor Intelligence
4. Perflutren: Uses, Interactions, Mechanism of Action - DrugBank Online
5. Lantheus Holdings, Inc. Reports Fourth Quarter and Full Year 2018 - Lantheus Holdings Inc.