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Last Updated: July 13, 2020

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LUMASON Drug Profile


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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 two patents protecting this drug.

This drug has one patent family member in one country.

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.

US ANDA Litigation and 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 November 13, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for LUMASON
Drug Prices for LUMASON

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Generic Entry Opportunity Date for LUMASON
Generic Entry Date for LUMASON*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
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

SponsorPhase
Cedars-Sinai Medical CenterPhase 1
UNC Lineberger Comprehensive Cancer CenterPhase 3
Mayo ClinicEarly Phase 1

See all LUMASON clinical trials

US Patents and Regulatory Information for LUMASON

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   Start Trial   Start Trial Y   Start Trial
Bracco LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bracco LUMASON sulfur hexafluoride lipid-type a microspheres FOR SUSPENSION;INTRAVENOUS 203684-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LUMASON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 SPC/GB14/018 United Kingdom   Start Trial 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
0619743 29/2001 Austria   Start Trial PRODUCT NAME: SCHWEFELHEXAFLUORID ENTHALTENDE, DURCH PHOSPHORLIPID STABILISIERTE MIKROBLAESCHEN; REGISTRATION NO/DATE: EU/1/01/177/001, EU/1/01/177/002 20010326
0619743 C300061 Netherlands   Start Trial PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326
1556389 16C0004 France   Start Trial 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
1556389 2015/074 Ireland   Start Trial PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
0619743 01C0036 France   Start Trial PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001 20010326
0619743 SPC/GB01/043 United Kingdom   Start Trial PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTERED: UK EU/1/01/177/001 20010326; UK EU/1/01/177/002 20010326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
AstraZeneca
Medtronic
Moodys
Merck

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