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NEURACEQ Drug Profile
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See Plans and PricingWhen 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
Summary for NEURACEQ
| International Patents: | 33 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Patent Applications: | 9 |
| DailyMed Link: | NEURACEQ at DailyMed |
Generic Entry Opportunity Date for NEURACEQ
Generic Entry Date for NEURACEQ*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
|---|---|
| William Charles Kreisl | Phase 1/Phase 2 |
| Ulsan University Hospital | N/A |
| National Institute on Aging (NIA) | Phase 2 |
Pharmacology for NEURACEQ
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
Synonyms for NEURACEQ
| [18F]BAY 94-9172 |
| 18F-BAY94-9172 |
| 18F-Florbetaben |
| 4-((1E)-2-(4-(2-(2-(2-((sup 18(f))fluoroethoxy)ethoxy)ethoxy)phenyl)eth-1-en-1-yl)-N-methylaniline |
| 4-[(E)-2-[4-[2-[2-(2-fluoranylethoxy)ethoxy]ethoxy]phenyl]ethenyl]-N-methylaniline |
| 4-{(E)-2-[4-(2-{2-[2-((18)F)fluoroethoxy]ethoxy}ethoxy)phenyl]ethenyl}-N-methylaniline |
| 902143-01-5 |
| AV-1 |
| BAY 94-9172 |
| BAY-949172 |
| BAY94-9172 |
| CHEBI:79033 |
| CHEMBL566752 |
| DB09148 |
| DTXSID20238065 |
| Florbetaben |
| 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] |
| GTPL7769 |
| Neuraceq (TN) |
| SCHEMBL11301755 |
| TLA7312TOI |
| UNII-TLA7312TOI |
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 |
International Patents for NEURACEQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101123995 | Start Trial |
| Eurasian Patent Organization | 200701299 | Start Trial |
| European Patent Office | 1841465 | Start Trial |
| Slovenia | 2213652 | Start Trial |
| Mexico | 2007007380 | Start Trial |
| Lithuania | C2213652 | Start Trial |
| South Korea | 101321619 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
