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Florbetapir f-18 - Generic Drug Details

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What are the generic drug sources for florbetapir f-18 and what is the scope of freedom to operate?

Florbetapir f-18 is the generic ingredient in one branded drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Florbetapir f-18 has forty-nine patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for florbetapir f-18

International Patents:	49
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	43
Patent Applications:	429
DailyMed Link:	florbetapir f-18 at DailyMed

Recent Clinical Trials for florbetapir f-18

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

Sponsor	Phase
Brain Health Alliance	Early Phase 1
Alzheimer's Association	Phase 2
Neil M Rofsky, MD, MHA	Phase 2

See all florbetapir f-18 clinical trials

Pharmacology for florbetapir f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for florbetapir f-18

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	202008-003	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
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

International Patents for florbetapir f-18

Country	Patent Number	Estimated Expiration
Japan	2009532349
European Patent Office	2363392
Hungary	S1300028
Guatemala	200800201
Denmark	1999109
Croatia	P20170857
Denmark	2363392

Supplementary Protection Certificates for florbetapir f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	122013000051	Germany		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	481	Finland
1999109	CA 2013 00035	Denmark
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
1999109	34/2013	Austria		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	13C0034	France		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014