Lumisight is a drug owned by Lumicell Inc. It is protected by 5 US drug patents filed in 2024 out of which none have expired yet. Lumisight's patents will be open to challenges from 17 April, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 14, 2034. Details of Lumisight's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9763577 | Imaging agent for detection of diseased cells |
Sep, 2034
(10 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9155471 | Methods and systems for spatially identifying abnormal cells |
Oct, 2031
(7 years from now) | Active |
| US10285759 | Methods and system for image guided cell ablation with microscopic resolution |
Dec, 2031
(7 years from now) | Active |
| US9532835 | Methods and system for image guided cell ablation with microscopic resolution |
Dec, 2031
(7 years from now) | Active |
| US9032965 | Methods and system for image guided cell ablation with microscopic resolution |
Dec, 2031
(7 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 Lumisight's patents.
Latest Legal Activities on Lumisight's Patents
Given below is the list of recent legal activities going on the following patents of Lumisight.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 03 Jul, 2024 | US9532835 |
| Change in Power of Attorney (May Include Associate POA) Critical | 21 Jun, 2024 | US9763577 |
| Email Notification Critical | 21 Jun, 2024 | US9763577 |
| Patent Term Extension Application under 35 USC 156 Filed | 14 Jun, 2024 | US9763577 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 13 Apr, 2023 | US9155471 |
| 7.5 yr surcharge - late pmt w/in 6 mo, Small Entity | 13 Feb, 2023 | US9032965 |
| Surcharge for late Payment, Small Entity | 13 Feb, 2023 | US10285759 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Feb, 2023 | US10285759 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 13 Feb, 2023 | US9032965 |
| Maintenance Fee Reminder Mailed Critical | 09 Jan, 2023 | US9032965 |
FDA has granted several exclusivities to Lumisight. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lumisight, 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 Lumisight.
Exclusivity Information
Lumisight holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Lumisight's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 17, 2029 |
US patents provide insights into the exclusivity only within the United States, but Lumisight 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 Lumisight's family patents as well as insights into ongoing legal events on those patents.
Lumisight's Family Patents
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Generic Launch
Generic Release Date:
Lumisight's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 14, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lumisight Generics:
There are no approved generic versions for Lumisight as of now.
About Lumisight
Lumisight is a drug owned by Lumicell Inc. Lumisight uses Pegulicianine Acetate as an active ingredient. Lumisight was launched by Lumicell in 2024.
Approval Date:
Lumisight was approved by FDA for market use on 17 April, 2024.
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 Lumisight is 17 April, 2024, its NCE-1 date is estimated to be 17 April, 2028.
Active Ingredient:
Lumisight uses Pegulicianine Acetate as the active ingredient. Check out other Drugs and Companies using Pegulicianine Acetate ingredient
Dosage:
Lumisight is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |