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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for fluciclovine f-18

International Patents:	30
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	41
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 1
Alliance for Clinical Trials in Oncology	Phase 3
Blue Earth Diagnostics, Inc	Phase 4

See all fluciclovine f-18 clinical trials

Pharmacology for fluciclovine f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for fluciclovine f-18

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Glossary

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

Expired US Patents for fluciclovine f-18

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054-001	May 27, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluciclovine f-18

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Country	Patent Number	Title	Estimated Expiration
Portugal	1978015		⤷ Sign Up
South Korea	20080071146	PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND	⤷ Sign Up
European Patent Office	3354639	COMPOSÉ PRÉCURSEUR DE COMPOSÉ ORGANIQUE MARQUÉ PAR UN ATOME D'HALOGÈNE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN-LABELED ORGANIC COMPOUND)	⤷ Sign Up
Israel	191184	ציקלובוטיל מותמר כתרכובת אב לתרכובות אורגנית המתויגת עם הלוגן רדיואקטיבי (Substituted cyclobutyl precursor compound for radioactive halogen-labeled organic compounds)	⤷ Sign Up
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)	⤷ Sign Up
Australia	2006319987	Precursor compound of radioactive halogen labeled organic compound	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.

Summary for fluciclovine f-18

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fluciclovine f-18

Recent Clinical Trials for fluciclovine f-18

Pharmacology for fluciclovine f-18

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fluciclovine f-18