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Last Updated: February 16, 2020

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NEURACEQ Drug Profile

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When do Neuraceq patents expire, and when can generic versions of Neuraceq launch?

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-three patent family members in twenty-five 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.

US ANDA Litigation and 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

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Summary for NEURACEQ
International Patents:33
US Patents:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 4
Patent Applications: 9
DailyMed Link:NEURACEQ at DailyMed
Drug patent expirations by year for NEURACEQ
Generic Entry Opportunity Date for NEURACEQ
Generic Entry Date for NEURACEQ*:
Constraining patent/regulatory exclusivity:

*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

William Charles KreislPhase 1/Phase 2
Ulsan University HospitalN/A
National Institute on Aging (NIA)Phase 2

See all NEURACEQ clinical trials

Pharmacology for NEURACEQ
Synonyms for NEURACEQ
[18F]BAY 94-9172
4-((1E)-2-(4-(2-(2-(2-((sup 18(f))fluoroethoxy)ethoxy)ethoxy)phenyl)eth-1-en-1-yl)-N-methylaniline
BAY 94-9172
florbetaben ((18)F)
Florbetaben ((sup 18)F)
Florbetaben (18F)
Florbetaben (18F) (JAN/INN)
Florbetaben (18F) [INN]
Florbetaben 18F [INN]
Florbetaben F 18
Florbetaben F-18
Florbetaben F18
Florbetaben f18 [USAN]
Neuraceq (TN)

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

Supplementary Protection Certificates for NEURACEQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213652 2015/008 Ireland   Start Trial PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652 15C0012 France   Start Trial PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140224
2213652 CA 2015 00018 Denmark   Start Trial PRODUCT NAME: FLORBETABEN (18F); REG. NO/DATE: EU/1/13/906/001 20140220
2213652 8/2015 Austria   Start Trial PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652 504 Finland   Start Trial
2213652 122015000018 Germany   Start Trial PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652 PA2015005 Lithuania   Start Trial PRODUCT NAME: FLORBETABENUM (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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