Florbetapir f-18 - Generic Drug Details

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 fifty patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for florbetapir f-18

International Patents:	50
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	47
DailyMed Link:	florbetapir f-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for florbetapir f-18

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 florbetapir f-18

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

Sponsor	Phase
Universidad Central del Caribe	Phase 2
University of Puerto Rico	Phase 2
Neuroscience Trials Australia	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	Yes	No			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	No			Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	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	202008-001	Apr 6, 2012		DISCN	Yes	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	202008-004	Oct 13, 2023		RX	Yes	Yes

International Patents for florbetapir f-18

Country	Patent Number	Title	Estimated Expiration
Poland	1999109
South Africa	200807955	STRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES
Denmark	1999109
Taiwan	200838852	Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Japan	2009532349
Japan	5290954
Croatia	P20120135

Supplementary Protection Certificates for florbetapir f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	481	Finland
1999109	CA 2013 00035	Denmark
1999109	92232	Luxembourg		PRODUCT NAME: FLORBETAPIR (18 F)
1999109	34/2013	Austria		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
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