NEURACEQ Drug Patent Profile

When do Neuraceq patents expire, and what generic alternatives are available?

Neuraceq is a drug marketed by Life Molecular and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-four patent family members in twenty-six countries.

The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Neuraceq

Neuraceq was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 18, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEURACEQ

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	101
What excipients (inactive ingredients) are in NEURACEQ?	NEURACEQ excipients list
DailyMed Link:	NEURACEQ at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for NEURACEQ

NDA:

204677

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 NEURACEQ

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

Sponsor	Phase
Life Molecular Imaging GmbH	Phase 3
William Charles Kreisl	Phase 1/Phase 2
Ulsan University Hospital	N/A

See all NEURACEQ clinical trials

US Patents and Regulatory Information for NEURACEQ

NEURACEQ is protected by one 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 NEURACEQ

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 NEURACEQ

When does loss-of-exclusivity occur for NEURACEQ?

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

Australia

Brazil

Canada

China

Costa Rica

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

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 NEURACEQ around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101321619
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)
Japan	5128956
Hungary	S1500014
Japan	4950031
Netherlands	300719

Supplementary Protection Certificates for NEURACEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132015902339134	Italy		PRODUCT NAME: FLORBETABEN (18)(NEURACEQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/906, 20140224
2213652	C02213652/01	Switzerland		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66210 23.08.2017
2213652	8/2015	Austria		PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652	92647	Luxembourg		PRODUCT NAME: FLORBETABEN (18F). FIRST REGISTRATION: 20140224