Florbetaben f-18 - Generic Drug Details

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

Florbetaben f-18 is the generic ingredient in one branded drug marketed by Life Molecular and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Florbetaben f-18 has thirty-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for florbetaben f-18

International Patents:	35
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	24
Patent Applications:	239
DailyMed Link:	florbetaben f-18 at DailyMed

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

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

Sponsor	Phase
University of Pennsylvania	Phase 3
National Institutes of Health (NIH)	Phase 3
Life Molecular Imaging GmbH	Phase 3

See all florbetaben f-18 clinical trials

Pharmacology for florbetaben f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for florbetaben f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes			Y	Y

International Patents for florbetaben f-18

Country	Patent Number	Title	Estimated Expiration
Denmark	2213652
Poland	2213652
South Africa	200705104	Stilbene derivatives and their use for binding and imaging amyloid plaques
South Korea	20070093427	STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES
South Korea	101321619
Japan	5128956
European Patent Office	2213652	Dérivés de stilbène et leur utilisation pour l'imagerie des plaques amyloïdes et leur liaison (Stilbene derivatives and their use for binding and imaging amyloid plaques)

Supplementary Protection Certificates for florbetaben f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	8/2015	Austria		PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652	132015902339134	Italy		PRODUCT NAME: FLORBETABEN (18)(NEURACEQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/906, 20140224
2213652	SPC/GB15/010	United Kingdom		PRODUCT NAME: FLORBETABEN (18F), WHICH IS (4-((E)-2-(4-(2-(2-(2-(1F)FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETHENYL)-N-METHYLANILINE); REGISTERED: UK EU/1/13/906/001 20140224
2213652	PA2015005	Lithuania		PRODUCT NAME: FLORBETABENUM (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	C02213652/01	Switzerland		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66210 23.08.2017
2213652	122015000018	Germany		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140224