Netspot is a drug owned by Advanced Accelerator Applications Usa Inc. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Netspot's patents have been open to challenges since 01 June, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 10, 2032. Details of Netspot's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9375498 | Process for the preparation of complexes of 68Ga |
Aug, 2032
(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 Netspot's patents.
Latest Legal Activities on Netspot's Patents
Given below is the list of recent legal activities going on the following patents of Netspot.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Dec, 2023 | US9375498 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Dec, 2019 | US9375498 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 27 Nov, 2017 | US9375498 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jun, 2016 | US9375498 |
| Recordation of Patent Grant Mailed Critical | 28 Jun, 2016 | US9375498 |
| Email Notification Critical | 09 Jun, 2016 | US9375498 |
| Issue Notification Mailed Critical | 08 Jun, 2016 | US9375498 |
| Mail Response to 312 Amendment (PTO-271) Critical | 03 Jun, 2016 | US9375498 |
| Email Notification Critical | 03 Jun, 2016 | US9375498 |
| Response to Amendment under Rule 312 Critical | 01 Jun, 2016 | US9375498 |
FDA has granted several exclusivities to Netspot. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Netspot, 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 Netspot.
Exclusivity Information
Netspot holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Netspot's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 01, 2021 |
| Orphan Drug Exclusivity(ODE) | Jun 01, 2023 |
| Orphan Drug Exclusivity(ODE-120) | Jun 01, 2023 |
US patents provide insights into the exclusivity only within the United States, but Netspot 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 Netspot's family patents as well as insights into ongoing legal events on those patents.
Netspot's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Netspot's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 10, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Netspot Generics:
There are no approved generic versions for Netspot as of now.
About Netspot
Netspot is a drug owned by Advanced Accelerator Applications Usa Inc. Netspot uses Gallium Dotatate Ga-68 as an active ingredient. Netspot was launched by Aaa Usa Inc in 2016.
Approval Date:
Netspot was approved by FDA for market use on 01 June, 2016.
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 Netspot is 01 June, 2016, its NCE-1 date is estimated to be 01 June, 2020.
Active Ingredient:
Netspot uses Gallium Dotatate Ga-68 as the active ingredient. Check out other Drugs and Companies using Gallium Dotatate Ga-68 ingredient
Dosage:
Netspot is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.1-5.5mCi/ML | POWDER | Prescription | INTRAVENOUS |