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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 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluciclovine f-18 has thirty-nine patent family members in sixteen countries.
One supplier is listed for this compound.
Summary for fluciclovine f-18
International Patents: | 39 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 27 |
Patent Applications: | 176 |
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
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1 |
Emory University | Phase 1 |
Baptist Health South Florida | Phase 1 |
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
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 | Start Trial | Start Trial | Start Trial | ||||
Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
>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
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 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluciclovine f-18
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 1120497 | Start Trial |
Taiwan | 200800869 | Start Trial |
South Korea | 20140108350 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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