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AXUMIN Drug Profile

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Which patents cover Axumin, and when can generic versions of Axumin launch?

Axumin is a drug marketed by Blue Earth and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-six patent family members in fifteen 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.

Summary for AXUMIN

International Patents:	36
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	6
Clinical Trials:	5
Patent Applications:	16
DailyMed Link:	AXUMIN at DailyMed

Generic Entry Opportunity Date for AXUMIN

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Pharmacology for AXUMIN

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

Synonyms for AXUMIN

(18F)FACBC

(18F)Fluciclovine

(18F)Ge-148

(1R,3R)-1-Amino-3(18f)fluorocyclobutane-1-carboxylic acid

[18F]-FACBC

[18F]FACBC

[18F]Fluciclovine

1-amino-3-fluoranylcyclobutane-1-carboxylic acid

18F fluciclovine

18F-Ge-148

222727-39-1

38R1Q0L1ZE

AC1L9P1E

AKOS030238192

anti-(18f)FABC

Anti-[18F]FACBC

anti-1-Amino-3-(18f)fluorocyclobutane-1-carboxylic acid

Anti-1-Amino-3-[18F]fluorocyclobutane-1-carboxylic acid

Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic-acid

Anti-1-amino-3-F-18-fluorocyclobutane-1-carboxylic-acid

Anti-1-amino-3-fluorine-18-fluorocyclobutane-1-carboxylic acid

Anti-18-F-FACBC

Anti-18F-FABC

Anti-3-18F-FACBC

Anti-F-18-fluorocyclobutane-carboxylic-acid

AxuminCN FACBCCN Fluciclovine (18F)CN GE 148CN NMK 36

CHEBI:134703

CHEMBL254468

CHEMBL447701

D03QIP

D10860

DB13146

FACBC

FACBC F-18

Fluciclovine

Fluciclovine ((sup 18)F)

Fluciclovine ((sup 18)F) [INN]

Fluciclovine (18F)

Fluciclovine (18F) (INN)

Fluciclovine (18F) [INN]

Fluciclovine F 18

Fluciclovine F-18

Fluciclovine F18 [USAN]

Fluciclovine-F-18

GE-148

Ge-148 (18F)

Ge-148 F-18

Ge-148-18F

Ge-148-F-18

MOLI001120

NMK36

SCHEMBL10017245

SCHEMBL11939897

SCHEMBL11939900

syn-1-Amino-3-[18F]fluorocyclobutane-1-carboxylic acid

syn-3-[18F]FACBC

Trans-1-amino-3-18F-fluorocyclobutanecarboxylic-acid

UNII-38R1Q0L1ZE

US Patents and Regulatory Information for 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				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			Y
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016		RX	Yes	Yes

International Patents for AXUMIN

Country	Document Number	Estimated Expiration
Taiwan	200800869
South Korea	101608755
Norway	341981
Norway	20082877
Australia	720738
Australia	2006319987