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Last Updated: August 11, 2020

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VIZAMYL Drug Profile

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Which patents cover Vizamyl, and what generic alternatives are available?

Vizamyl is a drug marketed by Ge Healthcare and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-one patent family members in twenty-four countries.

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

US ANDA Litigation and Generic Entry Outlook for Vizamyl

Vizamyl was eligible for patent challenges on October 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VIZAMYL
International Patents:81
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 3
Drug Prices: Drug price information for VIZAMYL
DailyMed Link:VIZAMYL at DailyMed
Drug patent expirations by year for VIZAMYL
Drug Prices for VIZAMYL

See drug prices for VIZAMYL

Generic Entry Opportunity Date for VIZAMYL
Generic Entry Date for VIZAMYL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;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 VIZAMYL

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

SponsorPhase
University Hospital, ToulouseEarly Phase 1
University of UtahN/A
Mayo ClinicPhase 2

See all VIZAMYL clinical trials

Pharmacology for VIZAMYL

US Patents and Regulatory Information for VIZAMYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare VIZAMYL flutemetamol f-18 INJECTABLE;INTRAVENOUS 203137-001 Oct 25, 2013 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Ge Healthcare VIZAMYL flutemetamol f-18 INJECTABLE;INTRAVENOUS 203137-002 Oct 25, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ge Healthcare VIZAMYL flutemetamol f-18 INJECTABLE;INTRAVENOUS 203137-001 Oct 25, 2013 DISCN Yes No   Start Trial   Start Trial Y Y   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 VIZAMYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1611115 2015/004 Ireland   Start Trial PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115 92634 Luxembourg   Start Trial PRODUCT NAME: FLUTEMETAMOL (18F) ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZAMYL). FIRST REGISTRATION: 20140826
2182988 122015000017 Germany   Start Trial PRODUCT NAME: FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Johnson and Johnson
AstraZeneca
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.