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AMYVID Drug Profile

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When do Amyvid patents expire, and when can generic versions of Amyvid launch?

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

This drug has forty-eight patent family members in thirty-two countries.

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.

US ANDA Litigation and Generic Entry Outlook for Amyvid

Amyvid was eligible for patent challenges on April 6, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 30, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMYVID

International Patents:	48
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	3
Clinical Trials:	35
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.

Recent Clinical Trials for AMYVID

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

Sponsor	Phase
Elisa Konofagou	N/A
National Institute on Aging (NIA)	N/A
National Institute on Aging (NIA)	Phase 3

See all AMYVID clinical trials

Pharmacology for AMYVID

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

Synonyms for AMYVID

[18F]Florbetapir

18F-AV-45

18F-AV45

18FAV45

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

DB09149

DTXSID80241898

Florbetapir

florbetapir (18F)

Florbetapir (18F) [INN]

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	Patent Number	Estimated Expiration
Luxembourg	92232
Canada	2644530
Cyprus	1119048
European Patent Office	2363391
Austria	539060
Spain	2378785

Supplementary Protection Certificates for AMYVID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014
1999109	C300600	Netherlands		PRODUCT NAME: FLORBETAPIR ( SUP 18 /SUP F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	1390030-3	Sweden		PRODUCT NAME: FLORBETAPIR (18F); REG. NO/DATE: EU/1/12/805 20130114
1999109	SPC/GB13/040	United Kingdom		PRODUCT NAME: FLORBETAPIR (18F) ((E)-4-(2-(6-(2-(2-(2-((18F)-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL)VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR (18F); REGISTERED: UK EU/1/12/805 20130117
1999109	2013C/044	Belgium		PRODUCT NAME: AMYVID - FLORBETAPIR (18F); AUTHORISATION NUMBER AND DATE: EU/1/12/805 20130114