Lutathera is a drug owned by Advanced Accelerator Applications Usa Inc. It is protected by 6 US drug patents filed from 2020 to 2024 out of which none have expired yet. Lutathera's patents will be open to challenges from 23 October, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2039. Details of Lutathera'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). | |||
|
US10596278 (Pediatric) | Stable, concentrated radionuclide complex solutions |
Jan, 2039
(14 years from now) | Active |
|
US10596276 (Pediatric) | Stable, concentrated radionuclide complex solutions |
Jan, 2039
(14 years from now) | Active |
|
US11904027 (Pediatric) | Stable, concentrated radionuclide complex solutions |
Jan, 2039
(14 years from now) | Active |
| US10596278 | Stable, concentrated radionuclide complex solutions |
Jul, 2038
(13 years from now) | Active |
| US10596276 | Stable, concentrated radionuclide complex solutions |
Jul, 2038
(13 years from now) | Active |
| US11904027 | Stable, concentrated radionuclide complex solutions |
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 Lutathera's patents.
Latest Legal Activities on Lutathera's Patents
Given below is the list of recent legal activities going on the following patents of Lutathera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 20 Feb, 2024 | US11904027 |
| Recordation of Patent eGrant | 20 Feb, 2024 | US11904027 |
| Recordation of Patent Grant Mailed Critical | 20 Feb, 2024 | US11904027 |
| Email Notification Critical | 20 Feb, 2024 | US11904027 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Feb, 2024 | US11904027 |
| Mail Patent eGrant Notification | 20 Feb, 2024 | US11904027 |
| Email Notification Critical | 01 Feb, 2024 | US11904027 |
| Issue Notification Mailed Critical | 31 Jan, 2024 | US11904027 |
| Dispatch to FDC | 17 Jan, 2024 | US11904027 |
| Issue Fee Payment Received Critical | 05 Oct, 2023 | US11904027 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lutathera and ongoing litigations to help you estimate the early arrival of Lutathera generic.
Lutathera's Litigations
Lutathera been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 02, 2020, against patent number US10596278. The petitioner Evergreen Theragnostics, Inc., challenged the validity of this patent, with Advanced Accelerator Applications SA as the respondent. Click below to track the latest information on how companies are challenging Lutathera's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10596276 | October, 2020 |
Institution Denied
(14 Apr, 2021) | Advanced Accelerator Applications SA | Evergreen Theragnostics, Inc. |
| US10596278 | October, 2020 |
Terminated-Denied
(14 Apr, 2021) | Advanced Accelerator Applications SA | Evergreen Theragnostics, Inc. |
FDA has granted some exclusivities to Lutathera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lutathera, 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 Lutathera.
Exclusivity Information
Lutathera holds 5 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Lutathera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 26, 2023 |
| Orphan Drug Exclusivity(ODE-166) | Jan 26, 2025 |
| New Patient Population(NPP) | Apr 23, 2027 |
| Orphan Drug Exclusivity(ODE-479) | Apr 23, 2031 |
| Pediatric Exclusivity(PED) | Oct 23, 2031 |
US patents provide insights into the exclusivity only within the United States, but Lutathera 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 Lutathera's family patents as well as insights into ongoing legal events on those patents.
Lutathera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lutathera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lutathera Generics:
There are no approved generic versions for Lutathera as of now.
About Lutathera
Lutathera is a drug owned by Advanced Accelerator Applications Usa Inc. Lutathera uses Lutetium Lu 177 Dotatate as an active ingredient. Lutathera was launched by Aaa Usa Inc in 2018.
Approval Date:
Lutathera was approved by FDA for market use on 26 January, 2018.
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 Lutathera is 26 January, 2018, its NCE-1 date is estimated to be 23 October, 2030.
Active Ingredient:
Lutathera uses Lutetium Lu 177 Dotatate as the active ingredient. Check out other Drugs and Companies using Lutetium Lu 177 Dotatate ingredient
Dosage:
Lutathera is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10mCi/ML | SOLUTION | Prescription | INTRAVENOUS |