Details for New Drug Application (NDA): 204677

NDA 204677 describes NEURACEQ, which is a drug marketed by Life Molecular and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the NEURACEQ profile page.

The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

Summary for 204677

Tradename:	NEURACEQ
Applicant:	Life Molecular
Ingredient:	florbetaben f-18
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204677

Constraining patent/regulatory exclusivity:

7,807,135

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: 204677

Mechanism of Action

Positron Emitting Activity

Suppliers and Packaging for NDA: 204677

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677	NDA	Life Molecular Imaging, Ltd	54828-001	54828-001-50	1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1.4-135mCi/ML
Approval Date:	Mar 19, 2014	TE:		RLD:	Yes
Patent:	7,807,135	Patent Expiration:	Mar 18, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT

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