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 | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 flutemetamol f-18
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-001 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VIZAMYL | flutemetamol f-18 | INJECTABLE;INTRAVENOUS | 203137-002 | Oct 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for flutemetamol f-18
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2393921 | ⤷ Sign Up | |
Portugal | 2264018 | ⤷ Sign Up | |
Norway | 20054674 | ⤷ Sign Up | |
New Zealand | 583616 | RADIOPHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
Japan | 2004506723 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for flutemetamol f-18
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2182988 | 573 | Finland | ⤷ Sign Up | |
1611115 | 2015/004 | Ireland | ⤷ Sign Up | PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822 |
2182988 | 2015006 | Norway | ⤷ Sign Up | PRODUCT NAME: VIZAMYL; REG. NO/DATE: EU/1/14/941 20140822 |
2182988 | 15C0006 | France | ⤷ Sign Up | PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822 |
1611115 | 122015000016 | Germany | ⤷ Sign Up | PRODUCT NAME: FLUTEMETAMOL (18F) ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/941 20140822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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