Lumason is a drug owned by Bracco Diagnostics Inc. It is protected by 4 US drug patents filed from 2016 to 2023. Out of these, 3 drug patents are active and 1 has expired. Lumason's patents have been open to challenges since 10 October, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be May 15, 2039. Details of Lumason's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US5686060 | Stable microbubble suspensions comprising saturated phospholipids for ultrasound echography |
Nov, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11723869 | Freeze-dried product and gas-filled microvesicles suspension |
May, 2039
(14 years from now) | Active |
| US10232061 | Freeze-dried formulation for gas-filled microvesicles |
Jul, 2038
(13 years from now) | Active |
| US10335502 | Freeze-dried formulation for gas-filled microvesicles |
Jul, 2038
(13 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lumason's patents.
Latest Legal Activities on Lumason's Patents
Given below is the list of recent legal activities going on the following patents of Lumason.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 15 Aug, 2023 | US11723869 |
| Recordation of Patent Grant Mailed Critical | 15 Aug, 2023 | US11723869 |
| Email Notification Critical | 15 Aug, 2023 | US11723869 |
| Patent eGrant Notification | 15 Aug, 2023 | US11723869 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Aug, 2023 | US11723869 |
| Recordation of Patent eGrant | 15 Aug, 2023 | US11723869 |
| Email Notification Critical | 27 Jul, 2023 | US11723869 |
| Electronic Review Critical | 27 Jul, 2023 | US11723869 |
| Issue Notification Mailed Critical | 26 Jul, 2023 | US11723869 |
| Dispatch to FDC | 29 Jun, 2023 | US11723869 |
FDA has granted several exclusivities to Lumason. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lumason, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lumason.
Exclusivity Information
Lumason holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Lumason's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-728) | Mar 31, 2019 |
| New Chemical Entity Exclusivity(NCE) | Oct 10, 2019 |
| New Patient Population(NPP) | Nov 13, 2022 |
US patents provide insights into the exclusivity only within the United States, but Lumason is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Lumason's family patents as well as insights into ongoing legal events on those patents.
Lumason's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lumason's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 15, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lumason Generics:
There are no approved generic versions for Lumason as of now.
About Lumason
Lumason is a drug owned by Bracco Diagnostics Inc. It is used for characterizing focal liver lesions with ultrasound in both adult and pediatric patients. Lumason uses Sulfur Hexafluoride Lipid-Type A Microspheres as an active ingredient. Lumason was launched by Bracco in 2014.
Approval Date:
Lumason was approved by FDA for market use on 15 October, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Lumason is 15 October, 2014, its NCE-1 date is estimated to be 10 October, 2018.
Active Ingredient:
Lumason uses Sulfur Hexafluoride Lipid-type A Microspheres as the active ingredient. Check out other Drugs and Companies using Sulfur Hexafluoride Lipid-type A Microspheres ingredient
Treatment:
Lumason is used for characterizing focal liver lesions with ultrasound in both adult and pediatric patients.
Dosage:
Lumason is available in for suspension form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60.7MG/25MG | FOR SUSPENSION | Prescription | INTRAVENOUS |