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Generated: January 22, 2019

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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 three 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
Applicant:Blue Earth
Ingredient:fluciclovine f-18
Generic Entry Opportunity Date for 208054
Generic Entry Date for 208054*:
Constraining patent/regulatory exclusivity:

*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 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)

Profile 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:➤ Sign UpPatent Expiration:Nov 28, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 9, 2020Product Flag?Substance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Fish and Richardson

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