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Last Updated: November 29, 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: 13
Clinical Trials: 36
Patent Applications: 208
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
Dragon Master FoundationEarly Phase 1
Baptist Health South FloridaPhase 2
Blue Earth Diagnostics, IncEarly 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 Y 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
Japan 2013177468 METHOD FOR PRODUCING RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND See Plans and Pricing
Japan WO2007063824 放射性ハロゲン標識有機化合物の前駆体化合物 See Plans and Pricing
Australia 2006319987 Precursor compound of radioactive halogen labeled organic compound See Plans and Pricing
Poland 1978015 See Plans and Pricing
Norway 20180010 Forløperforbindelse for radioaktive, halogenmerkede organiske forbindelser See Plans and Pricing
Norway 20082877 See Plans and Pricing
South Korea 101643991 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
McKesson
Dow
Baxter
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.