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 eight patents protecting this drug.
This drug has thirty 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
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Summary for AXUMIN
| International Patents: | 30 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 25 |
| Patent Applications: | 75 |
| What excipients (inactive ingredients) are in AXUMIN? | AXUMIN excipients list |
| DailyMed Link: | AXUMIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AXUMIN
*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 |
|---|---|
| Dana-Farber Cancer Institute | Phase 1 |
| Blue Earth Diagnostics, Inc | Phase 4 |
| OHSU Knight Cancer Institute | 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 eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AXUMIN is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
Imaging of metastatic or recurrent cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Precursor compound of radioactive halogen labeled organic compound
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0619213
Patent: composto precursor de composto orgánico marcado com haloênio radioativo
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 29227
Patent: COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1316812
Patent: Precursor compound of radioactive halogen labeled organic compound
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 78015
Patent: COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND)
Estimated Expiration: ⤷ Sign Up
Patent: 54639
Patent: COMPOSÉ PRÉCURSEUR DE COMPOSÉ ORGANIQUE MARQUÉ PAR UN ATOME D'HALOGÈNE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1184
Patent: ציקלובוטיל מותמר כתרכובת אב לתרכובות אורגנית המתויגת עם הלוגן רדיואקטיבי (Substituted cyclobutyl precursor compound for radioactive halogen-labeled organic compounds)
Estimated Expiration: ⤷ Sign Up
Patent: 5029
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 2007063824
Patent: 放射性ハロゲン標識有機化合物の前駆体化合物
Estimated Expiration: ⤷ Sign Up
Patent: 35225
Estimated Expiration: ⤷ Sign Up
Patent: 84333
Estimated Expiration: ⤷ Sign Up
Patent: 13177468
Patent: METHOD FOR PRODUCING RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8179
Patent: Cyclobutane derivative as a precursor compound of radioactive halogen labeled organic compound
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 1981
Estimated Expiration: ⤷ Sign Up
Patent: 18027
Estimated Expiration: ⤷ Sign Up
Patent: 082877
Estimated Expiration: ⤷ Sign Up
Patent: 180010
Patent: Forløperforbindelse for radioaktive, halogenmerkede organiske forbindelser
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 78015
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 78015
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 28415
Patent: СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ (RADIOACTIVE HALOGEN-LABELLED ORGANIC COMPOUND PRECURSOR)
Estimated Expiration: ⤷ Sign Up
Patent: 08126277
Patent: СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1608755
Estimated Expiration: ⤷ Sign Up
Patent: 1643991
Estimated Expiration: ⤷ Sign Up
Patent: 080071146
Patent: PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND
Estimated Expiration: ⤷ Sign Up
Patent: 130101158
Patent: PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND
Estimated Expiration: ⤷ Sign Up
Patent: 140108350
Patent: PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 63496
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 71439
Estimated Expiration: ⤷ Sign Up
Patent: 0800869
Patent: Precursor compound of radioactive halogen labeled organic compound
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 9717092 | ⤷ Sign Up | |
| Australia | 720738 | ⤷ Sign Up | |
| Russian Federation | 2428415 | СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ (RADIOACTIVE HALOGEN-LABELLED ORGANIC COMPOUND PRECURSOR) | ⤷ Sign Up |
| China | 101316812 | Precursor compound of radioactive halogen labeled organic compound | ⤷ Sign Up |
| South Korea | 20130101158 | PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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