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: | 12 |
Clinical Trials: | 18 |
Patent Applications: | 98 |
What excipients (inactive ingredients) are in AXUMIN? | AXUMIN excipients list |
DailyMed Link: | AXUMIN at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
---|---|
Baptist Health South Florida | Phase 1 |
University of Utah | Early Phase 1 |
Emory University | Phase 1 |
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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Imaging of metastatic or recurrent cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
Imaging of metastatic or recurrent cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
>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: See Plans and Pricing
Brazil
Patent: 0619213
Estimated Expiration: See Plans and Pricing
Canada
Patent: 29227
Estimated Expiration: See Plans and Pricing
China
Patent: 1316812
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 78015
Estimated Expiration: See Plans and Pricing
Patent: 54639
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1184
Estimated Expiration: See Plans and Pricing
Patent: 5029
Estimated Expiration: See Plans and Pricing
Japan
Patent: 2007063824
Estimated Expiration: See Plans and Pricing
Patent: 35225
Estimated Expiration: See Plans and Pricing
Patent: 84333
Estimated Expiration: See Plans and Pricing
Patent: 13177468
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 8179
Estimated Expiration: See Plans and Pricing
Norway
Patent: 1981
Estimated Expiration: See Plans and Pricing
Patent: 082877
Estimated Expiration: See Plans and Pricing
Patent: 180010
Estimated Expiration: See Plans and Pricing
Poland
Patent: 78015
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 78015
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 28415
Estimated Expiration: See Plans and Pricing
Patent: 08126277
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1608755
Estimated Expiration: See Plans and Pricing
Patent: 1643991
Estimated Expiration: See Plans and Pricing
Patent: 080071146
Estimated Expiration: See Plans and Pricing
Patent: 130101158
Estimated Expiration: See Plans and Pricing
Patent: 140108350
Estimated Expiration: See Plans and Pricing
Spain
Patent: 63496
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 71439
Estimated Expiration: See Plans and Pricing
Patent: 0800869
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Norway | 341981 | See Plans and Pricing | |
Japan | 5684333 | See Plans and Pricing | |
Norway | 20180010 | Forløperforbindelse for radioaktive, halogenmerkede organiske forbindelser | See Plans and Pricing |
South Korea | 101643991 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |