Details for New Drug Application (NDA): 208054

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NDA 208054 describes AXUMIN, which is a drug marketed by Blue Earth and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the AXUMIN profile page.

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 208054

Tradename:	AXUMIN
Applicant:	Blue Earth
Ingredient:	fluciclovine f-18
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208054

Generic Entry Date for 208054^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 NDA: 208054

Mechanism of Action	Positron Emitting Activity

Suppliers and Packaging for NDA: 208054

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001	69932-001-30	30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)
AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001	69932-001-50	50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	9-221mCi/ML
Approval Date:	May 27, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 28, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 30, 2035	Product Flag?		Substance Flag?		Delist Request?
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:	⤷ Sign Up	Patent Expiration:	Dec 30, 2035	Product Flag?		Substance Flag?		Delist Request?
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

Expired US Patents for NDA 208054

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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

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