FLUTEMETAMOL F-18 - Generic Drug Details

What are the generic sources for flutemetamol f-18 and what is the scope of patent protection?

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

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

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

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
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013

International Patents for FLUTEMETAMOL F-18

Country	Patent Number	Title	Estimated Expiration
Denmark	1334091
World Intellectual Property Organization (WIPO)	2004083195
Lithuania	PA2015001
Hong Kong	1086270	BENZOTHIAZOLE DERIVATIVE COMPOUNDS, COMPOSITIONS AND USES
World Intellectual Property Organization (WIPO)	0216333
Norway	330861

Supplementary Protection Certificates for FLUTEMETAMOL F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1611115	2015C/005	Belgium		PRODUCT NAME: FLUTEMETAMOL (18F); AUTHORISATION NUMBER AND DATE: EU/1/14/941 20140826
1611115	1590010-3	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
2182988	SPC/GB15/012	United Kingdom		PRODUCT NAME: FLUTEMETAMOL (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/941 20140826
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
1334091	PA2015001,C1334091	Lithuania		PRODUCT NAME: FLUTEMETAMOLIS (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	6/2015	Austria		PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826