Flutemetamol f-18 - Generic Drug Details

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-three patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for flutemetamol f-18

International Patents:	83
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	19
Patent Applications:	353
What excipients (inactive ingredients) are in flutemetamol f-18?	flutemetamol f-18 excipients list
DailyMed Link:	flutemetamol f-18 at DailyMed

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

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

International Patents for flutemetamol f-18

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2475267	РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)
Canada	2438032	DERIVES DE BENZOTHIAZOLE ET COMPOSITIONS ET UTILISATIONS CONNEXES (BENZOTHIAZOLE DERIVATIVE COMPOUNDS, COMPOSITIONS AND USES)
Cyprus	1113334

Supplementary Protection Certificates for flutemetamol f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	122015000017	Germany		PRODUCT NAME: FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
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	2015/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822