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Last Updated: June 27, 2022

FLUCICLOVINE F-18 - Generic Drug Details


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What are the generic drug sources for fluciclovine f-18 and what is the scope of freedom to operate?

Fluciclovine f-18 is the generic ingredient in one branded drug marketed by Blue Earth and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluciclovine f-18 has twenty-nine patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for FLUCICLOVINE F-18
International Patents:29
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 32
Patent Applications: 198
What excipients (inactive ingredients) are in FLUCICLOVINE F-18?FLUCICLOVINE F-18 excipients list
DailyMed Link:FLUCICLOVINE F-18 at DailyMed
Recent Clinical Trials for FLUCICLOVINE F-18

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baptist Health South FloridaPhase 1
M.D. Anderson Cancer CenterEarly Phase 1
University of UtahEarly Phase 1

See all FLUCICLOVINE F-18 clinical trials

Pharmacology for FLUCICLOVINE F-18

US Patents and Regulatory Information for FLUCICLOVINE F-18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FLUCICLOVINE F-18

Country Patent Number Title Estimated Expiration
Taiwan I371439 See Plans and Pricing
South Korea 20140108350 PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND See Plans and Pricing
European Patent Office 3354639 COMPOSÉ PRÉCURSEUR DE COMPOSÉ ORGANIQUE MARQUÉ PAR UN ATOME D'HALOGÈNE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND) See Plans and Pricing
China 101316812 Precursor compound of radioactive halogen labeled organic compound See Plans and Pricing
South Korea 20080071146 PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
McKinsey
McKesson
Harvard Business School
Merck

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