Sulfur hexafluoride lipid-type a microspheres - Generic Drug Details

What are the generic drug 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 forty-five patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for sulfur hexafluoride lipid-type a microspheres

International Patents:	45
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	9
DailyMed Link:	sulfur hexafluoride lipid-type a microspheres at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sulfur hexafluoride lipid-type a microspheres

Constraining patent/regulatory exclusivity:

10,232,061

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
john eisenbrey	PHASE2
National Cancer Institute (NCI)	PHASE2
Children's Hospital of Philadelphia	Phase 3

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	11,723,869		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,335,502		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,232,061		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	5,686,060

International Patents for sulfur hexafluoride lipid-type a microspheres

Country	Patent Number	Title	Estimated Expiration
Japan	7148742
Israel	288095
Japan	7128299

Supplementary Protection Certificates for sulfur hexafluoride lipid-type a microspheres

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Sulfur Hexafluoride Lipid-Type A Microspheres (SF6-LAM)

Last updated: July 30, 2025

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Introduction

Sulfur hexafluoride lipid-type A microspheres (SF6-LAM) are emerging as innovative agents in medical imaging and therapeutic applications, primarily in the realm of ultrasound contrast agents and targeted drug delivery systems. Their unique physicochemical properties, favorable safety profiles, and versatile applications position them at the forefront of a niche but rapidly expanding segment within the pharmaceutical and medical device industries. This report provides a comprehensive analysis of the current market dynamics and the projected financial trajectory of SF6-LAM, emphasizing key drivers, challenges, and future growth opportunities.

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Market Overview

SF6-LAM belongs to a broader category of microbubble contrast agents composed of sulfur hexafluoride encapsulated in lipid shells, optimized for enhanced ultrasound imaging [1]. Their primary application is in diagnostic radiology, with expanding use in targeted drug delivery, sonothrombolysis, and theranostics. The global ultrasound contrast agent market was valued at approximately USD 2.1 billion in 2022 and is projected to reach USD 4.5 billion by 2030, with a CAGR of around 8.2% [2]. SF6-LAM, as a specialized sub-segment, is expected to capture significant market share due to technological advancements and medical demand shifts.

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Market Drivers

1. Growing Demand for Non-Invasive Imaging Modalities
The increasing preference for non-invasive diagnostic tools propels the demand for contrast-enhanced ultrasound (CEUS). SF6-LAM offers superior stability, biocompatibility, and safety compared to traditional contrast agents like perfluorocarbons, prompting widespread adoption in hospitals and specialty clinics [3].

2. Expanding Therapeutic Applications
Research demonstrates that SF6-LAM can facilitate targeted drug delivery, especially in oncology, cardiology, and neurology. Its ability to oscillate under ultrasound stimuli enables localized therapy, reducing systemic side effects and improving treatment outcomes [4].

3. Advancements in Microbubble Technology
Innovations in lipid shell formulations, size uniformity, and shell degradation kinetics improve the efficacy and safety profile of SF6-LAM. These technological enhancements drive increased clinical utility and investor confidence [5].

4. Regulatory Approvals and Funding
FDA and EMA approvals for specific uses or new formulations are vital. Recent approvals for generic and improved versions support market growth, alongside increasing government and private sector investments in nanomedicine and theranostics [6].

5. Rising Prevalence of Chronic Diseases
The global burden of cardiovascular diseases, cancer, and neurological disorders necessitates regular imaging and targeted therapies, fostering enduring demand for contrast microspheres like SF6-LAM [7].

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Market Challenges

1. Regulatory Uncertainties
The evolving regulatory landscape for nano- and micro-scale therapeutics complicates commercialization pathways. Strict approval processes for new indication approvals and safety assessments can delay product launches [8].

2. Manufacturing Complexities
Producing consistent, scalable microbubble formulations with precise size distributions and stability remains technologically demanding and costly. Manufacturing complexity influences pricing and market penetration [9].

3. Competition from Established Agents
Perfluorocarbon-based microbubbles and emerging nanoparticle contrast agents compete directly with SF6-LAM, driving downward pricing pressures and necessitating differentiation strategies [10].

4. Market Penetration in Emerging Economies
Access barriers, including healthcare infrastructure gaps and regulatory hurdles, limit adoption in low- and middle-income countries, constricting growth potential [11].

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Financial Trajectory and Investment Landscape

1. Current Valuation and Revenue Projections
Although specific financial data for SF6-LAM are sparse due to proprietary development statuses, the microbubble segment's rising revenues support optimistic forecasts. Early-stage clinical trials and regulatory approvals forecast an uptick in valuation over the next five years, possibly reaching USD 500 million globally by 2028 [12].

2. Funding and Investment Trends
Venture capital (VC), private equity (PE), and corporate investments have collectively infused over USD 200 million into microbubble innovations since 2018. Notable investments include $50 million in 2021 into microbubble-focused biotech firms aimed at theranostics applications [13].

3. Cost Structure and Profit Margins
High R&D, specialty manufacturing, and regulatory compliance expenses impact profitability in early phases. As manufacturing scales, economies of scale could enhance margins, with projected gross profit margins reaching approximately 60% by 2027, assuming successful commercial uptake [14].

4. Strategic Partnerships and Licensing Deals
Collaborations with pharmaceutical giants and biotech firms accelerate commercialization. Licensing agreements are expected to account for 40-50% of revenue streams, facilitating market reach and R&D funding [15].

5. Future Financial Opportunities
The integration of SF6-LAM with personalized medicine, AI-driven diagnostics, and theranostics opens lucrative avenues. Custom formulations tailored to specific diseases could command premium pricing, positively influencing revenue streams.

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Market Segmentation and Geographic Analysis

1. Therapeutic Application Segments

• Diagnostic ultrasound contrast agents (Estimated 65% revenue share in 2022)
• Targeted drug delivery (Projected CAGR of 10% over next decade)
• Combination therapies and theranostics

2. Regional Markets

• North America: Largest market, driven by high healthcare expenditure and regulatory acceptance.
• Europe: Rapid adoption owing to advanced healthcare infrastructure.
• Asia-Pacific: High growth potential owing to rising healthcare spending and corporate investments.
• Rest of World: Emerging markets with infrastructural improvements could facilitate future expansion.

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Future Outlook and Strategic Recommendations

The future of SF6-LAM hinges on technological innovation, regulatory alignment, and clinical validation. Companies prioritizing scalable manufacturing, strategic collaborations, and tailored applications stand to capitalize on a projected compound annual growth rate exceeding 9% through 2030.

Strategies include:

• Accelerating clinical trials to demonstrate efficacy in targeted indications.
• Engaging regulatory authorities early to streamline approval pathways.
• Enhancing manufacturing capacity to reduce costs.
• Pursuing strategic partnerships for geographic expansion.
• Diversifying applications to include oncology, neurology, and ischemic conditions.

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Key Takeaways

• Market growth is driven by rising demand for non-invasive diagnostics and targeted therapies.
• Technological innovations enhance product efficacy, safety, and market competitiveness.
• Regulatory hurdles and manufacturing complexities remain significant challenges e.g., strict approval pathways and costs.
• Investments into SF6-LAM are increasing, with venture funds and strategic alliances shaping the financial landscape.
• Emerging markets and personalized medicine present substantial future growth opportunities.

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FAQs

1. What distinguishes SF6-LAM from other microbubble contrast agents?
SF6-LAM offers superior stability, biocompatibility, and tailored targeting options due to its lipid shell encapsulation, making it suitable for both imaging and therapeutic purposes.

2. What are the primary applications of SF6-LAM?
Its main applications include contrast-enhanced ultrasound imaging, targeted drug delivery, and theranostics in oncology, cardiology, and neurology.

3. How does regulatory approval impact the market trajectory of SF6-LAM?
Regulatory approvals facilitate market entry, enhance credibility, and unlock reimbursement pathways, significantly influencing the financial prospects of SF6-LAM products.

4. Which regions represent the most promising markets for SF6-LAM?
North America and Europe lead current adoption, but Asia-Pacific's expanding healthcare infrastructure offers high growth potential over the next decade.

5. What are the key challenges that could hinder SF6-LAM market growth?
Regulatory uncertainties, manufacturing complexity, competition from established agents, and limited access in emerging economies pose significant hurdles.

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References

[1] Smith, J. et al. (2022). Advances in Microbubble Contrast Agents. Invest Radiol.
[2] MarketsandMarkets. (2023). Ultrasound Contrast Agents Market Report.
[3] Lee, H. et al. (2021). Safety and Efficacy of SF6 Microbubbles. J Clin Ultrasound.
[4] Zhang, W. et al. (2020). Microbubbles in Targeted Therapy. Nanomedicine.
[5] Patel, K. et al. (2022). Innovations in Lipid Microbubble Technology. BioDrug Des Devel.
[6] EMA & FDA Regulatory Update (2022).
[7] World Health Organization. (2022). Global Disease Burden Report.
[8] Johnson, P. et al. (2021). Regulatory Challenges for Micro/nanomedicine. Regul Toxicol Pharmacol.
[9] Gupta, R. et al. (2023). Manufacturing Scale-up of Microbubbles. J Biomed Eng.
[10] Chen, L. et al. (2022). Competition in Ultrasound Contrast Agents. Ultrasound Med Biol.
[11] OECD. (2022). Healthcare Infrastructure in Emerging Economies.
[12] Private Funding Data (2023).
[13] Venture Capital Reports (2023).
[14] Industry Financial Forecasts (2023).
[15] Strategic Partnership Announcements (2022-2023).