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Last Updated: March 18, 2024

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: 17
Clinical Trials: 37
Patent Applications: 169
What excipients (inactive ingredients) are in fluciclovine f-18?fluciclovine f-18 excipients list
DailyMed Link:fluciclovine f-18 at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fluciclovine f-18
Generic Entry Date for fluciclovine f-18*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.

Recent Clinical Trials for fluciclovine f-18

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

SponsorPhase
Oregon Health and Science UniversityPhase 4
Blue Earth Diagnostics, IncPhase 4
OHSU Knight Cancer InstitutePhase 4

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 5635225 ⤷  Try a Trial
South Korea 20080071146 PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND ⤷  Try a Trial
Taiwan 200800869 Precursor compound of radioactive halogen labeled organic compound ⤷  Try a Trial
Spain 2663496 ⤷  Try a Trial
Israel 235029 שיטה לייצור 1-אמינו-3-[18f]פלואורוציקלובוטאן חומצה קרבוקסילית מתרכובת אב מסומנת (Method for the production of 1-amino-3-[18f]fluorocyclobutanecarboxylic acid from a labeled precursor compound) ⤷  Try a Trial
New Zealand 568179 Cyclobutane derivative as a precursor compound of radioactive halogen labeled organic compound ⤷  Try a Trial
South Korea 20130101158 PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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