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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

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
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203684
Generic Entry Date for 203684*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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.

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 0270-7099 0270-7099-73 5 KIT in 1 BOX (0270-7099-73) > 1 KIT in 1 KIT * 5 mL in 1 SYRINGE * 25 mg in 1 VIAL
LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684 NDA BRACCO DIAGNOSTICS INC 0270-7099 0270-7099-16 5 KIT in 1 BOX (0270-7099-16) > 1 KIT in 1 KIT * 5 mL in 1 SYRINGE * 25 mg in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;INTRAVENOUSStrength60.7MG/25MG
Approval Date:Oct 15, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 31, 2019
Regulatory Exclusivity Use:EXPANDED INDICATION FOR USE IN ULTRASONOGRAPHY OF THE LIVER FOR CHARACTERIZATION OF FOCAL LIVER LESIONS IN ADULT AND PEDIATRIC PATIENTS
Regulatory Exclusivity Expiration:Oct 10, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 13, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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