Flutemetamol f-18 - Generic Drug Details
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What are the generic sources for flutemetamol f-18 and what is the scope of freedom to operate?
Flutemetamol f-18
is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Flutemetamol f-18 has eighty-four patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for flutemetamol f-18
| International Patents: | 84 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 19 |
| Patent Applications: | 279 |
| What excipients (inactive ingredients) are in flutemetamol f-18? | flutemetamol f-18 excipients list |
| DailyMed Link: | flutemetamol f-18 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for flutemetamol f-18
Generic Entry Date for flutemetamol f-18*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;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 flutemetamol f-18
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yale University | Phase 1 |
| Shanghai Mental Health Center | Phase 4 |
| Maastricht University Medical Center | Phase 2/Phase 3 |
Pharmacology for flutemetamol f-18
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Radiopharmaceutical Activity |
US Patents and Regulatory Information for flutemetamol f-18
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
Expired US Patents for flutemetamol f-18
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for flutemetamol f-18
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1146710 | RADIOPHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
| Australia | 8670201 | Thioflavin derivatives for use in antemortem diagnosis of alzheimer's disease and in vivo imaging and prevention of amyloid deposition | ⤷ Try a Trial |
| Norway | 20054674 | ⤷ Try a Trial | |
| South Africa | 201000718 | Radiopharmaceutical composition | ⤷ Try a Trial |
| Belgium | 2015C005 | ⤷ Try a Trial | |
| New Zealand | 583616 | RADIOPHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
| Spain | 2395721 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for flutemetamol f-18
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1611115 | 1590010-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826 |
| 1611115 | 574 | Finland | ⤷ Try a Trial | |
| 1611115 | C 2015 004 | Romania | ⤷ Try a Trial | PRODUCT NAME: FLUTEMETAMOL (18 F) SAU O SARE, HIDRAT SAU SOLVAT ALACESTUIA ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/14/941; DATE OF NATIONAL AUTHORISATION: 20140822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/941; DATE OF FIRST AUTHORISATION IN EEA: 20140822 |
| 2182988 | 573 | Finland | ⤷ Try a Trial | |
| 2182988 | SPC/GB15/012 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FLUTEMETAMOL (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/941 20140826 |
| 2182988 | CA 2015 00008 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RADIOAKTIVE ISOTOPER AF FLUTEMETAMOL, SAERLIGT FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822 |
| 2182988 | 1590009-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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