AMYVID Drug Patent Profile

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.

This drug has forty-nine 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.

DrugPatentWatch^® 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:	49
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	39
Patent Applications:	264
What excipients (inactive ingredients) are in AMYVID?	AMYVID excipients list
DailyMed Link:	AMYVID at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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
University of Puerto Rico	Phase 2
Universidad Central del Caribe	Phase 2
Invicro	Phase 1

See all AMYVID clinical trials

Pharmacology for AMYVID

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for AMYVID

AMYVID is protected by two 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 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

When does loss-of-exclusivity occur for AMYVID?

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

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 AMYVID around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2008012527	DERIVADOS DE ESTIRILPIRIDINA Y SUS USOS PARA UNION A PLACAS AMILOIDES Y OBTENCION DE IMAGENES DE LAS MISMAS. (STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES.)
Singapore	173338	STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES
Denmark	1999109
Poland	2363392
Hungary	E032660
European Patent Office	1999109	DÉRIVÉS DE STYRYLPYRIDINE ET LEURS APPLICATIONS À LA LIAISON ET À L'IMAGERIE DE PLAQUES AMYLOÏDES (STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)

Supplementary Protection Certificates for AMYVID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	481	Finland
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
1999109	PA2013016	Lithuania		PRODUCT NAME: FLORBETAPIRUM; REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014
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(18F); REGISTERED: UK EU/1/12/805 20130117 )VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR