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
National Cancer Institute (NCI)	PHASE2
john eisenbrey	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	10,232,061		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,335,502		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
Brazil	112021022185
Canada	3137089
Singapore	11202010539R
China	120420464
South Korea	20220008827
South Korea	102742070

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
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	16C0004	France		PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 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

Market Dynamics and Financial Trajectory for SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

Last updated: February 15, 2026

What Is the Product and Its Indications?

Sulfur hexafluoride lipid-type A microspheres are a proprietary drug delivery system designed for medical imaging and targeted therapy. These microspheres are composed of sulfur hexafluoride gas encapsulated within a lipid matrix, enabling enhanced contrast in ultrasound imaging and potential therapeutic uses, such as drug delivery or embolization.

Defined by their unique properties, these microspheres are intended primarily for radiological diagnostics and interventional procedures. They are not approved for direct therapeutic interventions but serve as adjuncts in various minimally invasive treatments.

What Is the Current Market Landscape?

The global market for ultrasound contrast agents, predominantly involving microsphere-based products, reached approximately USD 1.7 billion in 2022, with an expected compound annual growth rate (CAGR) of 7% through 2030. Sulfur hexafluoride (SF6) is a common encapsulating agent present in several commercial contrast agents (e.g., SonoVue/Lumason). However, lipid-type microspheres based specifically on sulfur hexafluoride remain in clinical or preclinical development stages.

Key players include Bracco Imaging, GE Healthcare, and SonoStim. Licensed products like Lumason (Bracco) use SF6 gas but are not lipid-type microspheres; they serve as reference points for market size and regulatory pathways. Lipid-based microsphere formulations are fewer, with their market entry contingent on regulatory approval and demonstrating safety and efficacy.

How Does the Product Fit Into Market Trends?

The trend toward minimally invasive procedures and real-time imaging drives incremental demand for contrast agents. The push for more specific targeting enhances the appeal of lipid-type microspheres, especially for localized drug delivery or embolization in oncology, cardiology, and neurology.

In parallel, increasing regulatory scrutiny on contrast agents' safety profiles influences market dynamics. The switch from previous sulfur hexafluoride-based agents to advanced lipid formulations hinges on safety, stability, and imaging quality.

What Are Key Regulatory Milestones?

• FDA approval process: Contrast agents using sulfur hexafluoride microbubbles have gained approval (e.g., Lumason in 2012). No lipid-based SF6 microsphere formulations have secured FDA approval yet.

• EMA considerations: European agencies evaluate similar safety and efficacy criteria, dictating development timelines.

• Developmental stage: Most sulfur hexafluoride lipid microspheres are in preclinical testing or early-phase clinical trials, with regulatory approval expected at least 3-5 years post-completion of pivotal studies.

What Are Growth Drivers and Constraints?

Drivers:

• Growing demand for contrast-enhanced ultrasound (CEUS) in oncology, cardiology, and infectious diseases.
• Advancements in nanoparticle engineering facilitating targeted delivery.
• Reduced adverse reactions compared to iodinated contrast media.

Constraints:

• Regulatory hurdles for novel lipid-encapsulated SF6 microspheres.
• Competition from established agents with longer market presence.
• Manufacturing complexity and costs.
• Limited peer-reviewed clinical data at this stage.

What Is the Revenue Potential and Financial Outlook?

For a product in the developmental stage, financial projections depend on regulatory success, market adoption speed, and competitive positioning. Assuming successful approval within 4-5 years and capturing 10-15% of the CEUS contrast market, potential revenues could reach USD 150-300 million annually by year five post-launch.

Factors influencing this include:

• Pricing assumptions: USD 300-400 per dose.
• Adoption rate: 30-40% of hospitals performing CEUS procedures.
• Expansion into therapeutic applications, such as drug delivery, could diversify revenue streams.

R&D costs for novel lipid-type SF6 microspheres are estimated at USD 50-80 million to reach commercialization, including clinical trials, regulatory fees, and manufacturing scale-up.

How Will Competitive Dynamics Evolve?

• Traditional contrast agents like SonoVue/Sonovue will maintain dominance due to existing regulatory approvals and established safety profiles.
• New entrants with lipid SF6 microspheres will seek niches demanding enhanced targeting or safety.
• Biotech firms focusing on nanomedicine may accelerate innovation.
• Partnerships with device manufacturers (e.g., ultrasound equipment providers) will influence adoption.

Conclusion

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES occupy a niche within ultrasound contrast agents, with developmental activity indicating a potential shift toward more targeted, safer options. Market penetration depends heavily on regulatory success, clinical validation, and competitive positioning, with revenue prospects promising if regulatory and clinical milestones are achieved within projected timelines.

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Key Takeaways

• Currently, lipid-type sulfur hexafluoride microspheres are in early development, with no approved commercial products.
• The global ultrasound contrast agent market is growing at a 7% CAGR, reaching USD 1.7 billion by 2030.
• Regulatory approval timelines are 3-5 years from successful clinical trials.
• Revenue potential post-approval could reach USD 150-300 million annually, contingent on market adoption and pricing.
• Competition will center on safety, imaging quality, and targeted delivery capabilities.

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FAQs

1. What distinguishes sulfur hexafluoride lipid microspheres from existing contrast agents?
They combine sulfur hexafluoride gas with a lipid shell, potentially offering enhanced stability, safety, and targeting capabilities over traditional microbubble contrast agents.

2. When might these microspheres become commercially available?
If clinical trials are successful, regulatory approval could occur within 3-5 years, with commercialization beginning shortly thereafter.

3. How do regulatory hurdles affect market entry?
Stringent evaluation of safety, efficacy, and manufacturing processes delays product launch and increases development costs.

4. Could these microspheres be used for therapeutic purposes?
Potentially. Their design supports targeted drug delivery or embolization, but this application remains experimental.

5. What factors could accelerate or hinder adoption?
Acceleration depends on clinical success and regulatory clearance; barriers include safety concerns, manufacturing costs, and competition from existing agents.

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References

[1] MarketsandMarkets. "Ultrasound Contrast Agents Market," 2022.
[2] FDA. "Ultrasound Contrast Agents – Recent Approvals and Guidelines," 2022.
[3] GlobalData. "Emerging Nanocarrier Technologies in Medical Imaging," 2023.
[4] European Medicines Agency. "Guidelines on CEUS Contrast Agents," 2022.