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*:
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
| Sponsor | Phase |
|---|---|
| Dana-Farber Cancer Institute | Phase 1 |
| Alliance for Clinical Trials in Oncology | Phase 3 |
| Blue Earth Diagnostics, Inc | Phase 4 |
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 | 10,010,632 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | 10,933,147 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | 10,953,112 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | 10,967,077 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | 9,387,266 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Blue Earth | AXUMIN | fluciclovine f-18 | SOLUTION;INTRAVENOUS | 208054-001 | May 27, 2016 | RX | Yes | Yes | 11,980,674 | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 | 5,808,146 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluciclovine f-18
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101316812 | Precursor compound of radioactive halogen labeled organic compound | ⤷ Subscribe |
| European Patent Office | 1978015 | COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND) | ⤷ Subscribe |
| Canada | 2629227 | COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND) | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2007063824 | ⤷ Subscribe | |
| Norway | 20180010 | Forløperforbindelse for radioaktive, halogenmerkede organiske forbindelser | ⤷ Subscribe |
| Poland | 1978015 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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