LUMASON Drug Patent Profile

When do Lumason patents expire, and when can generic versions of Lumason launch?

Lumason is a drug marketed by Bracco and is included in one NDA. There are three patents protecting this drug.

This drug has forty-one patent family members in thirteen countries.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumason

Lumason was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMASON

International Patents:	41
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	31
Drug Prices:	Drug price information for LUMASON
What excipients (inactive ingredients) are in LUMASON?	LUMASON excipients list
DailyMed Link:	LUMASON at DailyMed

See drug prices for LUMASON

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

NDA:

203684

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 LUMASON

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

Sponsor	Phase
Milton S. Hershey Medical Center	Early Phase 1
Mayo Clinic	Phase 2
Thomas Jefferson University	Phase 2

See all LUMASON clinical trials

Pharmacology for LUMASON

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

US Patents and Regulatory Information for LUMASON

LUMASON is protected by five US patents.

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
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 LUMASON

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 LUMASON

When does loss-of-exclusivity occur for LUMASON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Japan

Mexico

Singapore

South Korea

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

See the table below for additional patents covering LUMASON around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3137088
Denmark	0554213
Poland	166827
Norway	305385
South Africa	9103729
Iceland	4239
World Intellectual Property Organization (WIPO)	2020229643

Supplementary Protection Certificates for LUMASON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0619743	C300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326
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	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	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
0619743	29/2001	Austria		PRODUCT NAME: SCHWEFELHEXAFLUORID ENTHALTENDE, DURCH PHOSPHORLIPID STABILISIERTE MIKROBLAESCHEN; REGISTRATION NO/DATE: EU/1/01/177/001, EU/1/01/177/002 20010326
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

Market Dynamics and Financial Trajectory for LUMASON

Introduction to LUMASON

LUMASON, developed by Bracco Diagnostics Inc., is a groundbreaking ultrasound contrast agent made up of sulfur hexafluoride lipid-type A microspheres. These microspheres reflect sound waves, enhancing the images obtained through ultrasonography. Here, we delve into the market dynamics and financial trajectory of LUMASON, highlighting its approvals, uses, and financial implications.

FDA Approvals and Clinical Indications

LUMASON has garnered several significant FDA approvals, each expanding its clinical indications:

• Echocardiography: Initially approved in October 2014 for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border. This approval was later extended to pediatric patients in December 2019[4].
• Liver Imaging: In March 2016, LUMASON became the first ultrasound contrast agent approved for use in liver imaging to differentiate between malignant and benign focal hepatic lesions in both adult and pediatric patients[1][4].
• Vesicoureteral Reflux: Additionally, it was approved in December 2016 for the evaluation of suspected or known vesicoureteral reflux in pediatric patients[4].

Global Market Presence

LUMASON, known as SonoVue outside the U.S., has been marketed globally since 2001 and is currently available in more than 44 countries. Its widespread acceptance and use underscore its efficacy and safety profile[4].

Market Impact

The approvals and expanded indications for LUMASON have significantly impacted the diagnostic imaging market:

• Competitive Advantage: As the first ultrasound contrast agent to receive FDA approval for various critical indications, LUMASON has established Bracco Diagnostics Inc. as a leader in the contrast imaging sector[1][4].
• Patient Benefits: The enhanced imaging capabilities provided by LUMASON have improved diagnostic accuracy, particularly in cases where traditional ultrasonography is suboptimal. This has led to better patient outcomes and increased trust among healthcare professionals[1][4].

Financial Trajectory

The financial performance of Bracco Diagnostics Inc., particularly in relation to LUMASON, can be inferred from several key points:

• Revenue Impact: While specific revenue figures for LUMASON are not publicly disclosed, the expansion of its indications and global market presence suggest a positive impact on Bracco Diagnostics Inc.'s revenue. The company's overall financial health and investments in imaging activities indicate a strong financial trajectory[1][4].
• Research and Development: The continuous investment in research and development to expand the clinical indications of LUMASON reflects a commitment to innovation and market growth. This investment is likely to yield long-term financial benefits as new indications are approved and the product becomes more widely adopted[1][4].

Safety and Efficacy

The safety and efficacy of LUMASON have been rigorously evaluated and confirmed by the FDA:

• Common Adverse Reactions: The most common adverse reactions include headache (1%) and nausea (0.5%). However, there are more serious potential risks such as systemic embolization in patients with cardiac shunts and ventricular arrhythmia related to high mechanical index[3].
• Regulatory Compliance: The FDA approvals and the company's collaborative work with regulatory bodies ensure that LUMASON meets stringent safety and efficacy standards, further solidifying its market position[1][4].

Competitive Landscape

In the diagnostic imaging market, LUMASON faces competition from other contrast agents, but its unique approvals and indications set it apart:

• Market Leadership: Bracco Diagnostics Inc.'s leadership in contrast imaging is reinforced by LUMASON's pioneering status in various clinical indications. This leadership position helps the company maintain a competitive edge in the market[1][4].

Future Outlook

The future outlook for LUMASON is promising, given its expanding indications and global acceptance:

• Continued Innovation: Bracco Diagnostics Inc.'s commitment to research and development suggests that LUMASON may receive additional approvals for new indications, further enhancing its market presence and financial performance[1][4].
• Global Expansion: As healthcare systems around the world adopt advanced diagnostic tools, the demand for LUMASON is likely to increase, contributing to its continued financial growth.

Key Takeaways

• FDA Approvals: LUMASON has received multiple FDA approvals for various critical indications, including echocardiography, liver imaging, and vesicoureteral reflux evaluation.
• Global Presence: Available in over 44 countries, LUMASON has a significant global market presence.
• Safety and Efficacy: Rigorously evaluated and confirmed by the FDA, LUMASON has a well-documented safety and efficacy profile.
• Financial Impact: The expansion of indications and global market presence suggest a positive financial trajectory for Bracco Diagnostics Inc.
• Competitive Edge: LUMASON's unique approvals and indications position it as a leader in the diagnostic imaging market.

FAQs

1. What is LUMASON used for?

   • LUMASON is an ultrasound contrast agent used to enhance images in various diagnostic procedures, including echocardiography, liver imaging, and the evaluation of vesicoureteral reflux.

2. Who approved LUMASON for use in the U.S.?

   • LUMASON was approved by the U.S. Food and Drug Administration (FDA) for its various indications.

3. What are the common adverse reactions associated with LUMASON?

   • The most common adverse reactions include headache (1%) and nausea (0.5%)[3].

4. Is LUMASON safe for pediatric patients?

   • Yes, LUMASON has been approved for use in pediatric patients for several indications, including echocardiography and liver imaging, and has been found to have a positive safety and efficacy profile in these populations[1][4].

5. How widely is LUMASON available?

   • LUMASON is available in more than 44 countries worldwide and is known as SonoVue outside the U.S.[4].

Sources

1. PR Newswire: First Approval by U.S. Food and Drug Administration for Contrast Enhanced Ultrasonography of the Liver Received by Bracco Diagnostics Inc. for LUMASON.
2. Lumos Pharma: Lumos Pharma Reports Second Quarter 2024 Financial Results and Provides Business Update.
3. LUMASON: Ultrasound Enhancing Agent - LUMASON.
4. PR Newswire: Bracco Diagnostics Inc.'s LUMASON (sulfur hexafluoride lipid-type A microspheres for injectable suspension) for intravenous use or intravesical use receives U.S. Food and Drug Administration approval for use in echocardiography.