SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES - Generic Drug Details

What are the generic sources for sulfur hexafluoride lipid-type a microspheres and what is the scope of freedom to operate?

Sulfur hexafluoride lipid-type a microspheres is the generic ingredient in one branded drug marketed by Bracco and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sulfur hexafluoride lipid-type a microspheres has thirty-seven patent family members in twelve countries.

One supplier is listed for this compound.

Summary for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

International Patents:	37
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	8
DailyMed Link:	SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Dosage:

FOR SUSPENSION;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 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

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

Sponsor	Phase
Bracco Diagnostics, Inc	Phase 3
Children's Hospital of Philadelphia	Phase 3
Children's Mercy Hospital Kansas City	Phase 2

See all SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES clinical trials

Pharmacology for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

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

Anatomical Therapeutic Chemical (ATC) Classes for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

D10AB	Preparations containing sulfur
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y

Expired US Patents for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014

International Patents for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020008031
Japan	2022532344	ガス充填微小胞
South Korea	20240010559	동결 건조 제품 및 가스 충전된 미세소포 현탁액 (FREEZE-DRIED PRODUCT AND GAS-FILLED MICROVESICLES SUSPENSION)
Canada	3137088	PRODUIT LYOPHILISE ET SUSPENSION DE MICROVESICULES REMPLIES DE GAZ (FREEZE-DRIED PRODUCT AND GAS-FILLED MICROVESICLES SUSPENSION)

Supplementary Protection Certificates for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	SPC/GB14/018	United Kingdom		PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
1556389	SPC/GB16/002	United Kingdom		PRODUCT NAME: CEFTOLOZANE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR A SULFURIC ACID SALT.; REGISTERED: UK EU/1/15/1032 20150922
1556389	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
1556389	2015/074	Ireland		PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfur Hexafluoride Lipid-Type A Microspheres

Introduction

Sulfur hexafluoride lipid-type A microspheres, marketed under the brand name Lumason, are an ultrasound contrast agent used to enhance the clarity of ultrasound images, particularly in diagnosing heart, liver, and urinary tract issues. Here, we will delve into the market dynamics and financial trajectory of this drug.

Regulatory Approval and Market Entry

Lumason received FDA approval on October 10, 2014, under Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act. This approval marked a significant milestone, allowing the drug to enter the market for commercial use[5].

Clinical Utility and Market Need

The drug's primary utility is in improving the delineation of cardiac borders during echocardiograms, which is crucial for diagnosing cardiac issues. Clinical studies have consistently shown that sulfur hexafluoride lipid microspheres enhance the ability to visualize left ventricular endocardial borders, thereby aiding in accurate diagnoses[4].

Market Segmentation

Diagnostic Procedures

Lumason is primarily used in echocardiography, a common diagnostic procedure for heart conditions. The demand for this drug is closely tied to the frequency of echocardiograms and other ultrasound-based diagnostic procedures.

Patient Population

The drug is used across various patient populations, including those with cardiac, liver, and urinary tract issues. Elderly patients, who are more sensitive to the effects of this medication, also constitute a significant segment[3].

Competitive Landscape

The market for ultrasound contrast agents is relatively niche but growing due to advancements in diagnostic technologies. Lumason competes with other ultrasound contrast agents, although its unique formulation and FDA approval give it a competitive edge.

Financial Performance

Revenue Growth

The approval and subsequent market entry of Lumason in 2014 contributed to significant revenue growth. The drug's impact on the overall market for ultrasound contrast agents has been substantial, with Lumason becoming a leading product in this category.

Spending Trends

In the broader context of pharmaceutical spending, specialty medicines like Lumason have driven significant growth. In 2014, specialty medicines accounted for a large portion of new brand spending, with drugs for conditions such as hepatitis C, multiple sclerosis, and cancer leading the way. Although Lumason is not specifically mentioned in these reports, it fits into the category of specialty medicines that have seen increased spending[2].

Pricing and Reimbursement

Pricing Dynamics

The pricing of Lumason is influenced by the overall trends in pharmaceutical pricing. In 2014, brand net prices increased by 5-7% on average, driven by invoice price changes and excluding the impact of rebates and contract pricing agreements. While specific pricing data for Lumason is not available, it is likely that the drug follows similar pricing trends[2].

Reimbursement

Reimbursement policies play a crucial role in the financial trajectory of any drug. Lumason, being an FDA-approved drug, is eligible for reimbursement under various healthcare plans. The reimbursement landscape can affect the drug's adoption and revenue growth.

Market Drivers

Technological Advancements

Advancements in ultrasound technology and the increasing use of echocardiograms drive the demand for contrast agents like Lumason. Improved diagnostic capabilities and the need for clearer images enhance the market for this drug.

Regulatory Environment

The FDA approval process and subsequent regulatory oversight ensure that Lumason meets stringent safety and efficacy standards. A favorable regulatory environment supports the drug's market presence and growth.

Market Challenges

Competition from New Technologies

Emerging diagnostic technologies and new contrast agents could pose a challenge to Lumason's market share. Continuous innovation and clinical evidence supporting its efficacy are essential to maintaining its competitive position.

Cost and Access

High costs associated with specialty medicines can limit access, especially in regions with stringent healthcare budgets. This could impact the drug's adoption and revenue growth.

Financial Projections

Given the growing demand for diagnostic procedures and the specialized nature of Lumason, the financial trajectory is expected to be positive. Here are some key points:

• Revenue Growth: Expected to continue as the use of echocardiograms and other ultrasound-based diagnostics increases.
• Market Share: Lumason is likely to maintain a significant market share due to its FDA approval and clinical efficacy.
• Pricing: Prices may adjust based on market dynamics, but the drug's unique value proposition is expected to support its pricing strategy.

Key Takeaways

• Regulatory Approval: FDA approval in 2014 marked a significant milestone for Lumason.
• Clinical Utility: The drug enhances the clarity of ultrasound images, particularly in cardiac diagnostics.
• Market Segmentation: Primarily used in echocardiography and other ultrasound-based diagnostic procedures.
• Financial Performance: Contributes to revenue growth in the specialty medicines segment.
• Pricing and Reimbursement: Influenced by broader pharmaceutical pricing trends and reimbursement policies.
• Market Drivers: Technological advancements and a favorable regulatory environment drive demand.
• Market Challenges: Competition from new technologies and cost-related access issues.

FAQs

What is the primary use of sulfur hexafluoride lipid-type A microspheres?

The primary use is to enhance the clarity of ultrasound images, particularly during echocardiograms, to help diagnose or find problems in the heart, liver, and urinary tract.

When did Lumason receive FDA approval?

Lumason received FDA approval on October 10, 2014[5].

How does Lumason improve diagnostic procedures?

Lumason improves the delineation of cardiac borders during echocardiograms, aiding in accurate diagnoses[4].

What are the potential side effects of Lumason?

While extensive clinical studies indicate a safe profile, elderly patients are more sensitive to the effects of this medication. There are also considerations for breastfeeding women due to limited studies[3].

How does Lumason fit into the broader pharmaceutical market?

Lumason is part of the specialty medicines segment, which has seen significant growth driven by new treatments for conditions like hepatitis C, multiple sclerosis, and cancer[2].

What are the key market drivers for Lumason?

Technological advancements in ultrasound technology and a favorable regulatory environment are key drivers for Lumason's market presence and growth.

Sources

1. Draft Guidance on Sulfur Hexafluoride Lipid-type A Microsphere - FDA
2. Medicines Use and Spending Shifts - IQVIA
3. Sulfur hexafluoride lipid type A microspheres (injection route) - Mayo Clinic
4. 203684Orig1s000 - accessdata.fda.gov - FDA
5. In Re: Patent Term Extension - Regulations.gov