➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
McKinsey
Merck
Colorcon
Boehringer Ingelheim

Last Updated: July 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203684


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 two 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:2
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 * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE
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 * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE

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:Nov 13, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Jul 6, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 6, 2038Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Dow
Johnson and Johnson
AstraZeneca
Merck
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.