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VIZAMYL Drug Patent Profile

Which patents cover Vizamyl, and what generic alternatives are available?

Vizamyl is a drug marketed by Ge Healthcare and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-four patent family members in twenty-five countries.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Vizamyl

Vizamyl was eligible for patent challenges on October 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIZAMYL

International Patents:	84
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	99
Drug Prices:	Drug price information for VIZAMYL
What excipients (inactive ingredients) are in VIZAMYL?	VIZAMYL excipients list
DailyMed Link:	VIZAMYL at DailyMed

See drug prices for VIZAMYL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIZAMYL

NDA:

203137

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 VIZAMYL

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

Sponsor	Phase
Yale University	Phase 1
University of Utah	Phase 2
University Hospital, Toulouse	Early Phase 1

See all VIZAMYL clinical trials

Pharmacology for VIZAMYL

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for VIZAMYL

VIZAMYL is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VIZAMYL

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	203137-002	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
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

Expired US Patents for VIZAMYL

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

International Patents for VIZAMYL

When does loss-of-exclusivity occur for VIZAMYL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIZAMYL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4875487
China	1784392	Benzothiazole derivative compounds,compositions and uses
Denmark	1611115
Japan	5022554
Russian Federation	2475267	РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)
Brazil	PI0815129	COMPOSIÇÃO RADIOFARMACÊUTICA, E, MÉTODOS PARA PREPARAÇÃO DE UMA COMPOSIÇÃO RADIOFARMACÊUTICA, E PARA DETERMINAÇÃO DA PRESENÇA, LOCALIZAÇÃO E/OU QUANTIDADE DE UM OU MAIS DEPÓSITOS DE AMILÓIDE EM UM ÓRGÃO OU ÁREA DO CORPO DE UM INDIVÍDUO
Mexico	2010002196	COMPOSICION RADIOFARMACEUTICA. (RADIOPHARMACEUTICAL COMPOSITION.)

Supplementary Protection Certificates for VIZAMYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	573	Finland
2182988	15C0006	France		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	193 5003-2015	Slovakia		PRODUCT NAME: FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	1590010-3	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
1611115	2015/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	15C0005	France		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	CR 2015 00009	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826