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Last Updated: May 26, 2022

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

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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
Drug patent expirations by year for AXUMIN
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

SponsorPhase
Baptist Health South FloridaPhase 1
University of UtahEarly Phase 1
Emory UniversityPhase 1

See all AXUMIN clinical trials

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Harvard Business School
Colorcon
Johnson and Johnson
McKinsey

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.