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Flutemetamol f-18 - Generic Drug Details

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What are the generic drug 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flutemetamol f-18 has eighty-one patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for flutemetamol f-18

International Patents:	81
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	18
Patent Applications:	14
DailyMed Link:	flutemetamol f-18 at DailyMed

Recent Clinical Trials for flutemetamol f-18

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Maastricht University Medical Center	Phase 2/Phase 3
New York University School of Medicine	Phase 1
University Hospital, Toulouse	Early Phase 1

See all flutemetamol f-18 clinical trials

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			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes			Y	Y

International Patents for flutemetamol f-18

Country	Patent Number	Estimated Expiration
Hong Kong	1146725
Denmark	1334091
Denmark	2264018
Slovenia	1611115
Poland	1611115
Norway	330176
Canada	2419420

Supplementary Protection Certificates for flutemetamol f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	2015/005	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	C300723	Netherlands		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	C 2015 004	Romania		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	CA 2015 00008	Denmark		PRODUCT NAME: RADIOAKTIVE ISOTOPER AF FLUTEMETAMOL, SAERLIGT FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822
1611115	CA 2015 00009	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822
2182988	15C0006	France		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	C20150004 00139	Estonia		PRODUCT NAME: FLUTEMETAMOOL (18F);REG NO/DATE: EU/1/14/941 26.08.2014