Axumin Patent Expiration

Axumin is a drug owned by Blue Earth Diagnostics Ltd. It is protected by 8 US drug patents filed from 2016 to 2021. Out of these, 7 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 30, 2035. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5808146 Amino acid analogs for tumor imaging
Nov, 2020

(3 years ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10953112 Precursor compound of radioactive halogen-labeled organic compound
Nov, 2026

(2 years from now)

Active
US9387266 Precursor compound of radioactive halogen-labeled organic compound
Nov, 2026

(2 years from now)

Active
US10010632 Precursor compound of radioactive halogen-labeled organic compound
Nov, 2026

(2 years from now)

Active
US10967077 Imaging of metastatic or recurrent cancer
Dec, 2035

(11 years from now)

Active
US10716868 Imaging of metastatic or recurrent cancer
Dec, 2035

(11 years from now)

Active
US10124079 Imaging of metastatic or recurrent cancer
Dec, 2035

(11 years from now)

Active
US10933147 Imaging of metastatic or recurrent cancer
Dec, 2035

(11 years from now)

Active


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

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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

Axumin has patent protection in a total of 16 countries. It's US patent count contributes only to 36.1% of its total global patent coverage. Click below to unlock the full patent family tree for Axumin.

Family Patents

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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 Dec 30, 2035 (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.

Market Authorisation Date:

Axumin was approved by FDA for market use on 27 May, 2016.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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