Detectnet is a drug owned by Radiomedix Inc. It is protected by 4 US drug patents filed from 2020 to 2024 out of which none have expired yet. Detectnet's patents have been open to challenges since 03 September, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 03, 2041. Details of Detectnet'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). | |||
| US12102696 | Radiolabeling and formulation for scale up of 64Cu-DOTATATE |
Sep, 2041
(16 years from now) | Active |
| US10159759 | Pet tracer for imaging of neuroendocrine tumors |
Aug, 2032
(7 years from now) | Active |
| US10383961 | PET tracer for imaging of neuroendocrine tumors |
Aug, 2032
(7 years from now) | Active |
| US11160888 | PET tracer for imaging of neuroendocrine tumors |
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 Detectnet's patents.
Latest Legal Activities on Detectnet's Patents
Given below is the list of recent legal activities going on the following patents of Detectnet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Eligible | 11 Jun, 2024 | US10383961 |
| Requirement for information sent under 37 CFR 1.750 | 11 Jun, 2024 | US10383961 |
| FDA Final Eligibility Letter Critical | 30 Jan, 2024 | US10383961 |
| transaction for FDA Determination of Regulatory Review Period | 10 May, 2023 | US10383961 |
| transaction for FDA Determination of Regulatory Review Period | 18 Apr, 2023 | US10383961 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Feb, 2023 | US10383961 |
| Second letter to regulating agency to determine regulatory review period | 17 Jun, 2022 | US10383961 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Jun, 2022 | US10159759 |
| Letter from FDA or Dept of Agriculture re PTE application | 14 Jun, 2022 | US10383961 |
| Initial letter Re: PTE Application to regulating agency | 13 Apr, 2022 | US10383961 |
FDA has granted several exclusivities to Detectnet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Detectnet, 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 Detectnet.
Exclusivity Information
Detectnet holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Detectnet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 03, 2025 |
| Orphan Drug Exclusivity(ODE-317) | Sep 03, 2027 |
US patents provide insights into the exclusivity only within the United States, but Detectnet 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 Detectnet's family patents as well as insights into ongoing legal events on those patents.
Detectnet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Detectnet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 03, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Detectnet Generics:
There are no approved generic versions for Detectnet as of now.
About Detectnet
Detectnet is a drug owned by Radiomedix Inc. It is used for localizing somatostatin receptor positive neuroendocrine tumors in adult patients. Detectnet uses Copper Cu-64 Dotatate as an active ingredient. Detectnet was launched by Radiomedix in 2020.
Approval Date:
Detectnet was approved by FDA for market use on 03 September, 2020.
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 Detectnet is 03 September, 2020, its NCE-1 date is estimated to be 03 September, 2024.
Active Ingredient:
Detectnet uses Copper Cu-64 Dotatate as the active ingredient. Check out other Drugs and Companies using Copper Cu-64 Dotatate ingredient
Treatment:
Detectnet is used for localizing somatostatin receptor positive neuroendocrine tumors in adult patients.
Dosage:
Detectnet is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4mL (1mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |