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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204677

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NDA 204677 describes NEURACEQ, which is a drug marketed by Piramal Imaging 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:Piramal Imaging
Ingredient:florbetaben f-18
Patents:1
Generic Entry Opportunity Date for 204677
Generic Entry Date for 204677*:
Constraining patent/regulatory exclusivity:
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 ActionPositron 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 Piramal Imaging, SA 54828-001 54828-001-30 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-30) > 30 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength30ML (1.4-135mCi/ML)
Approval Date:Mar 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 21, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Mar 18, 2029Product Flag?YSubstance Flag?YDelist 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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