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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 flutemetamol f-18 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flutemetamol f-18 has seventy-six patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for flutemetamol f-18

International Patents:	76
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

Pharmacology for flutemetamol f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

Synonyms for flutemetamol f-18

((18 sup)F)AH110690

[18F]-Flutemetamol

[18F]-Flutemetamol F18

[18F]AH110690

[18F]flutemetamol

18F-Flutemetamol

2-(3-((18 sup)F)Fluoro-4-(methylamino)phenyl)-1,3-benzothiazol-6-ol

2-(3-(sup 18)f)Fluoro-4-(methylamino)phenyl)-1,3-benzothiazol-6-ol

2-[3-((18)F)fluoro-4-(methylamino)phenyl]-1,3-benzothiazol-6-ol

2-[3-(18F)fluoro-4-(methylamino)phenyl]-1,3-benzothiazol-6-ol

6-Benzothiazolol, 2-(3-(fluoro-(sup 18)F)-4-(methylamino)phenyl)-

765922-62-1

CHEBI:76611

CHEMBL2042122

D10231

DB09151

DTXSID80227394

Flutemetamol

flutemetamol ((18)F)

Flutemetamol ((sup 18)F)

Flutemetamol ((sup18)F)

flutemetamol (18F)

Flutemetamol (18F) [INN]

Flutemetamol F 18

Flutemetamol F 18 (USAN)

Flutemetamol F 18 [USAN]

flutemetamol F 18 injection

Flutemetamol F18

GTPL7342

L49M066S0O

SCHEMBL10032147

UNII-L49M066S0O

Vizamyl

Vizamyl (TN)

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

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Non-Orange Book US Patents for flutemetamol f-18

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,854,920	Thioflavin derivatives for use in antemortem diagnosis of alzheimer's disease and in vivo imaging and prevention of amyloid deposition
8,404,213	Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition
8,911,707	Thioflavin derivatives for use in antemortem diagnosis of alzheimer's disease and in vivo imaging and prevention of amyloid deposition
9,134,328	Methods of using benzothiazole derivative compounds and compositions
9,808,541	Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition
9,833,458	Thioflavin derivatives for use in the antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition

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International Patents for flutemetamol f-18

Country	Document Number	Estimated Expiration
Poland	360550
Japan	2004506723
Hong Kong	1146710
European Patent Office	1334091
China	102532055
Poland	215711
Norway	330176

Supplementary Protection Certificates for flutemetamol f-18

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3 5003-2015	Slovakia		PRODUCT NAME: FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2015000017	Germany		PRODUCT NAME: FLUTEMETAMOL (18F) IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/14/941 20140822
15/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2015001	Lithuania		PRODUCT NAME: FLUTEMETAMOLUM (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
90009-5	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
2015	Austria		PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826
90010-3	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826