Details for New Drug Application (NDA): 203684

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NDA 203684 describes LUMASON, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LUMASON profile page.

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.

Summary for 203684

Tradename:	LUMASON
Applicant:	Bracco
Ingredient:	sulfur hexafluoride lipid-type a microspheres
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203684

Generic Entry Date for 203684^: ⤷ Subscribe* 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.

Pharmacology for NDA: 203684

Mechanism of Action	Ultrasound Contrast Activity

Suppliers and Packaging for NDA: 203684

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7097	0270-7097-08	20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL
LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7097	0270-7097-07	20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;INTRAVENOUS			Strength	60.7MG/25MG
Approval Date:	Oct 15, 2014	TE:		RLD:	Yes
Patent:	10,232,061	Patent Expiration:	Jul 6, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,335,502	Patent Expiration:	Jul 6, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,723,869	Patent Expiration:	May 15, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE IN ADULT AND PEDIATRIC PATIENTS WITH SUBOPTIMAL ECHOCARDIOGRAMS TO OPACIFY THE LEFT VENTRICULAR CHAMBER AND TO IMPROVE THE DELINEATION OF THE LEFT VENTRICULAR ENDOCARDIAL BORDER

Expired US Patents for NDA 203684

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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	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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