AXUMIN Drug Patent Profile

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

NDA:

208054

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

See all AXUMIN clinical trials

US Patents and Regulatory Information for AXUMIN

AXUMIN is protected by seven US patents.

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

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
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes			Y
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes

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

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

Brazil

Canada

China

European Patent Office

Israel

Japan

New Zealand

Norway

Poland

Portugal

Russian Federation

South Korea

Spain

Taiwan

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
Japan	5684333
Norway	20180010	Forløperforbindelse for radioaktive, halogenmerkede organiske forbindelser
South Korea	101643991