Axumin is a drug owned by Blue Earth Diagnostics Ltd. It is protected by 9 US drug patents filed from 2016 to 2024. Out of these, 8 drug patents are active and 1 has expired. Axumin's patents have been open to challenges since 27 May, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 23, 2042. Details of Axumin'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. | |||
| US5808146 | Amino acid analogs for tumor imaging |
Nov, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11980674 | Imaging of metastatic or recurrent cancer |
Apr, 2042
(16 years from now) | Active |
| US10716868 | Imaging of metastatic or recurrent cancer |
Dec, 2035
(10 years from now) | Active |
| US10933147 | Imaging of metastatic or recurrent cancer |
Dec, 2035
(10 years from now) | Active |
| US10124079 | Imaging of metastatic or recurrent cancer |
Dec, 2035
(10 years from now) | Active |
| US10967077 | Imaging of metastatic or recurrent cancer |
Dec, 2035
(10 years from now) | Active |
| US10010632 | Precursor compound of radioactive halogen-labeled organic compound |
Nov, 2026
(1 year, 4 months from now) | Active |
| US9387266 | Precursor compound of radioactive halogen-labeled organic compound |
Nov, 2026
(1 year, 4 months from now) | Active |
| US10953112 | Precursor compound of radioactive halogen-labeled organic compound |
Nov, 2026
(1 year, 4 months 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 Axumin's patents.
Latest Legal Activities on Axumin's Patents
Given below is the list of recent legal activities going on the following patents of Axumin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 28 Jun, 2024 | US10124079 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Jun, 2024 | US10124079 |
| Email Notification Critical | 28 Jun, 2024 | US10716868 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Jun, 2024 | US10716868 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Jun, 2024 | US10933147 |
| Email Notification Critical | 28 Jun, 2024 | US10933147 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Jun, 2024 | US10967077 |
| Email Notification Critical | 20 Jun, 2024 | US10967077 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2024 | US10716868 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2024 | US9387266 |
FDA has granted several exclusivities to Axumin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Axumin, 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 Axumin.
Exclusivity Information
Axumin holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Axumin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 27, 2021 |
US patents provide insights into the exclusivity only within the United States, but Axumin 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 Axumin's family patents as well as insights into ongoing legal events on those patents.
Axumin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Axumin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 23, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Axumin Generics:
There are no approved generic versions for Axumin as of now.
About Axumin
Axumin is a drug owned by Blue Earth Diagnostics Ltd. It is used for diagnostic imaging of suspected prostate cancer recurrence in adults based on elevated blood prostate specific antigen levels. Axumin uses Fluciclovine F-18 as an active ingredient. Axumin was launched by Blue Earth in 2016.
Approval Date:
Axumin was approved by FDA for market use on 27 May, 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 Axumin is 27 May, 2016, its NCE-1 date is estimated to be 27 May, 2020.
Active Ingredient:
Axumin uses Fluciclovine F-18 as the active ingredient. Check out other Drugs and Companies using Fluciclovine F-18 ingredient
Treatment:
Axumin is used for diagnostic imaging of suspected prostate cancer recurrence in adults based on elevated blood prostate specific antigen levels.
Dosage:
Axumin is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 9-221mCi/ML | SOLUTION | Prescription | INTRAVENOUS |