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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.

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:	5
Clinical Trials:	36
Patent Applications:	216
What excipients (inactive ingredients) are in AMYVID?	AMYVID excipients list
DailyMed Link:	AMYVID at DailyMed

DrugPatentWatch^® Estimated 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
National Institute on Aging (NIA)	N/A
Elisa Konofagou	N/A
University of California, Irvine	Phase 3

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

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

International Patents for AMYVID

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007126733
European Patent Office	2363392
Norway	342090

Supplementary Protection Certificates for AMYVID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	13C0034	France		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C 2013 023	Romania		PRODUCT NAME: FLORBETAPIR(18F)4-[(1E)-2-(6-{2-[2-(2-[18F]FLUOROETOXI)ETOXI]ETOXI}PIRIDIN-3-IL)ETENIL]-N-METILBENZENAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/12/805; DATE OF NATIONAL AUTHORISATION: 20130114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/805; DATE OF FIRST AUTHORISATION IN EEA: 20130114
1999109	2013/028	Ireland		PRODUCT NAME: FLORBETAPIR (18F), OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/805 20130114