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-five 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:	45
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	37
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
Columbia University	PHASE1
NaviFUS Corporation	NA
University of Cincinnati	NA

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 Africa

South Korea

Spain

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
Australia	2019298652	Freeze-dried formulation for gas-filled microvesicles
Brazil	112020022883	formulação liofilizada para microvesículas preenchidas com gás
Canada	3098380	FORMULATION LYOPHILISEE POUR MICROVESICULES REMPLIES DE GAZ (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)
China	112165959	用于充气微泡的冻干制剂 (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)

Supplementary Protection Certificates for LUMASON

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
0619743	C300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326
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
0619743	SPC/GB01/043	United Kingdom		PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTERED: UK EU/1/01/177/001 20010326; UK EU/1/01/177/002 20010326