LUMASON Drug Patent 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 three patents protecting this drug.
This drug has thirty-four patent family members in twelve 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: | 34 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 29 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LUMASON |
What excipients (inactive ingredients) are in LUMASON? | LUMASON excipients list |
DailyMed Link: | LUMASON at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUMASON
Generic Entry Date for LUMASON*:
Constraining patent/regulatory exclusivity:
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
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 2 |
Thomas Jefferson University | Phase 2 |
Children's Hospital of Philadelphia | Phase 1 |
Pharmacology for LUMASON
Drug Class | Contrast Agent for Ultrasound Imaging |
Mechanism of Action | Ultrasound Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LUMASON
US Patents and Regulatory Information for LUMASON
LUMASON is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUMASON is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LUMASON
Freeze-dried formulation for gas-filled microvesicles
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Freeze-dried formulation for gas-filled microvesicles
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN ULTRASONOGRAPHY OF THE URINARY TRACT IN PEDIATRIC PATIENTS FOR THE EVALUATION OF SUSPECTED OR KNOWN VESICOURETERAL REFLUX
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE WITH ULTRASOUND OF THE LIVER IN ADULT AND PEDIATRIC PATIENTS TO CHARACTERIZE FOCAL LIVER LESIONS
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684-001 | Oct 15, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684-001 | Oct 15, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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
Patent: 19298652
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2020022883
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 98380
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2165959
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 17777
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 28299
Estimated Expiration: ⤷ Try a Trial
Patent: 21529730
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 20012604
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202010539R
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2556398
Estimated Expiration: ⤷ Try a Trial
Patent: 210029712
Estimated Expiration: ⤷ Try a Trial
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 | 5336294 | ⤷ Try a Trial | |
Norway | 930041 | ⤷ Try a Trial | |
Denmark | 0619743 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUMASON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1556389 | SPC/GB16/002 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CEFTOLOZANE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR A SULFURIC ACID SALT.; REGISTERED: UK EU/1/15/1032 20150922 |
1345920 | SPC/GB14/018 | United Kingdom | ⤷ Try a 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 |
1556389 | 2015/074 | Ireland | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |