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Generated: September 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208547

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NDA 208547 describes NETSPOT, which is a drug marketed by Aaa Usa Inc 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 NETSPOT profile page.

The generic ingredient in NETSPOT is gallium dotatate ga-68. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatate ga-68 profile page.
Summary for 208547
Tradename:NETSPOT
Applicant:Aaa Usa Inc
Ingredient:gallium dotatate ga-68
Patents:1
Generic Entry Opportunity Date for 208547
Generic Entry Date for 208547*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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.

Suppliers and Packaging for NDA: 208547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NETSPOT gallium dotatate ga-68 POWDER;INTRAVENOUS 208547 NDA Advanced Accelerator Applications USA, Inc 69488-001 69488-001-40 1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength2.1-5.5mCi/ML
Approval Date:Jun 1, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 1, 2023
Regulatory Exclusivity Use:FOR USE AFTER RADIOLABELING WITH GA 68, WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS.
Regulatory Exclusivity Expiration:Jun 1, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Aug 10, 2032Product Flag?YSubstance Flag?Delist Request?

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