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Serving leading biopharmaceutical companies globally:

Accenture
Express Scripts
Queensland Health
Daiichi Sankyo
Cerilliant
Merck
Argus Health
Citi
US Department of Justice
Chubb

Generated: December 15, 2017

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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 fluciclovine f-18 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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluciclovine f-18 has thirty-three patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for fluciclovine f-18

Pharmacology for fluciclovine f-18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Blue EarthAXUMINfluciclovine f-18SOLUTION;INTRAVENOUS208054-001May 27, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Blue EarthAXUMINfluciclovine f-18SOLUTION;INTRAVENOUS208054-001May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Blue EarthAXUMINfluciclovine f-18SOLUTION;INTRAVENOUS208054-001May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fluciclovine f-18

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,817,776 Amino acid analogs for tumor imaging► Subscribe
9,381,259Precursor compound of radioactive halogen-labeled organic compound► Subscribe
8,758,724Unnatural amino acid radiolabeling precursor► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fluciclovine f-18

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9717092► Subscribe
Japan2013177468► Subscribe
Japan3992736► Subscribe
Japan5684333► Subscribe
Japan2000500442► Subscribe
Australia1120497► Subscribe
Japan5635225► Subscribe
Israel235029► Subscribe
BrazilPI0619213► Subscribe
South Korea20080071146► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Healthtrust
Fuji
Cantor Fitzgerald
Baxter
Federal Trade Commission
US Army
Moodys
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 verifification 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.

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