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AMYVID Drug Profile

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When do Amyvid patents expire, and what generic alternatives are available?

Amyvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this drug.

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

Summary for AMYVID

US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	2
Clinical Trials:	33
Patent Applications:	7
DailyMed Link:	AMYVID at DailyMed

Generic Entry Opportunity Date for AMYVID

NDA:

202008

Dosage:

SOLUTION;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.

Pharmacology for AMYVID

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

Synonyms for AMYVID

[18F]Florbetapir

18F-AV-45

4-((1E)-2-(6-{2-(2-(2-(18F)fluoroethoxy)ethoxy)ethoxy}pyridin-3-yl)ethenyl)-N- methylbenzenamine

4-(2-(6-(2-(2-(2-Fluoroethoxy)ethoxy)ethoxy)pyridin-3-yl)vinyl)-N-methylbenzamide

4-[(E)-2-[6-(2-{2-[2-(18F)fluoroethoxy]ethoxy}ethoxy)pyridin-3-yl]ethenyl]-N-methylaniline

4-{(E)-2-[6-(2-{2-[2-((18)F)fluoroethoxy]ethoxy}ethoxy)pyridin-3-yl]ethenyl}-N-methylaniline

4-{(E)-2-[6-(2-{2-[2-(18F)fluoroethoxy]ethoxy}ethoxy)pyridin-3-yl]ethenyl}-N-methylaniline

6W15Z5R0RU

956103-76-7

Amyvid (TN)

AV-45

AV-45 compound

Benzenamine, 4-((1E)-2-(6-(2-(2-(2-(fluoro-18F)ethoxy)ethoxy)ethoxy)-3- pyridinyl)ethenyl)-N- methyl-

CHEBI:66880

CHEMBL1774461

D09617

D09CGE

DB09149

DTXSID80241898

Florbetapir

florbetapir (18F)

Florbetapir F 18

Florbetapir F-18

Florbetapir F-18 (USAN)

Florbetapir F-18 [USAN:INN]

florbetapir F18

florbetapir-fluorine-18

GTPL7344

Pet AV-45

SCHEMBL14826096

UNII-6W15Z5R0RU

YNDIAUKFXKEXSV-CRYLGTRXSA-N

US Patents and Regulatory Information for AMYVID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	No	No			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		RX	Yes	Yes			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	No	No			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		RX	Yes	Yes			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-003	Apr 6, 2012		RX	Yes	Yes			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-003	Apr 6, 2012		RX	Yes	Yes			Y	Y

International Patents for AMYVID

Country	Document Number	Estimated Expiration
Hungary	S1300028
Portugal	2363392
Denmark	2363392
Hungary	E032660
Japan	2009532349
Brazil	PI0710225
Austria	539060

Supplementary Protection Certificates for AMYVID

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1	Finland
232	Luxembourg		PRODUCT NAME: FLORBETAPIR (18 F)
00600	Netherlands		PRODUCT NAME: FLORBETAPIR ( SUP 18 /SUP F); REGISTRATION NO/DATE: EU/1/12/805 20130114
0130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
90030-3	Sweden		PRODUCT NAME: FLORBETAPIR (18F); REG. NO/DATE: EU/1/12/805 20130114
13/028	Ireland		PRODUCT NAME: FLORBETAPIR (18F), OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014