AXUMIN Drug Patent Profile
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Which patents cover Axumin, and what generic alternatives are available?
Axumin is a drug marketed by Blue Earth and is included in one NDA. There are seven patents protecting this drug.
This drug has twenty-nine patent family members in sixteen countries.
The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this compound. Additional details are available on the fluciclovine f-18 profile page.
DrugPatentWatch® Generic Entry Outlook for Axumin
Axumin was eligible for patent challenges on May 27, 2020.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 28, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AXUMIN
| International Patents: | 29 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 22 |
| Patent Applications: | 84 |
| What excipients (inactive ingredients) are in AXUMIN? | AXUMIN excipients list |
| DailyMed Link: | AXUMIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AXUMIN
Generic Entry Date for AXUMIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for AXUMIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| OHSU Knight Cancer Institute | Phase 4 |
| Oregon Health and Science University | Phase 4 |
| Blue Earth Diagnostics, Inc | Phase 4 |
Pharmacology for AXUMIN
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
US Patents and Regulatory Information for AXUMIN
AXUMIN is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AXUMIN is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AXUMIN
Precursor compound of radioactive halogen-labeled organic compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
Precursor compound of radioactive halogen-labeled organic compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
Precursor compound of radioactive halogen-labeled organic compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AXUMIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AXUMIN
When does loss-of-exclusivity occur for AXUMIN?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06319987
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0619213
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 29227
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1316812
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 78015
Estimated Expiration: ⤷ Try a Trial
Patent: 54639
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1184
Estimated Expiration: ⤷ Try a Trial
Patent: 5029
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2007063824
Estimated Expiration: ⤷ Try a Trial
Patent: 35225
Estimated Expiration: ⤷ Try a Trial
Patent: 84333
Estimated Expiration: ⤷ Try a Trial
Patent: 13177468
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8179
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 1981
Estimated Expiration: ⤷ Try a Trial
Patent: 082877
Estimated Expiration: ⤷ Try a Trial
Patent: 180010
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 78015
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 78015
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 28415
Estimated Expiration: ⤷ Try a Trial
Patent: 08126277
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1608755
Estimated Expiration: ⤷ Try a Trial
Patent: 1643991
Estimated Expiration: ⤷ Try a Trial
Patent: 080071146
Estimated Expiration: ⤷ Try a Trial
Patent: 130101158
Estimated Expiration: ⤷ Try a Trial
Patent: 140108350
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 63496
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 71439
Estimated Expiration: ⤷ Try a Trial
Patent: 0800869
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering AXUMIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 235029 | שיטה לייצור 1-אמינו-3-[18f]פלואורוציקלובוטאן חומצה קרבוקסילית מתרכובת אב מסומנת (Method for the production of 1-amino-3-[18f]fluorocyclobutanecarboxylic acid from a labeled precursor compound) | ⤷ Try a Trial |
| South Korea | 101643991 | ⤷ Try a Trial | |
| China | 101316812 | Precursor compound of radioactive halogen labeled organic compound | ⤷ Try a Trial |
| Russian Federation | 2008126277 | СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ | ⤷ Try a Trial |
| Taiwan | I371439 | ⤷ Try a Trial | |
| Japan | WO2007063824 | 放射性ハロゲン標識有機化合物の前駆体化合物 | ⤷ Try a Trial |
| Japan | 5684333 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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