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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
QuintilesIMS
Novartis
Queensland Health
Fuji
Deloitte
AstraZeneca
Moodys
US Army

Generated: October 19, 2017

DrugPatentWatch Database Preview

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 two 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 NDA: 208054

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2

Pharmacology for NDA: 208054

Mechanism of ActionPositron 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9-221mCi/ML
Approval Date:May 27, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Nov 9, 2018Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Nov 28, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Cipla
US Army
Deloitte
Express Scripts
Daiichi Sankyo
Cantor Fitzgerald
McKinsey
Julphar

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