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Last Updated: May 8, 2021

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AMYVID Drug Profile

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

Amyvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has forty-nine patent family members in thirty-two countries.

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

DrugPatentWatch® Generic Entry Outlook for Amyvid

Amyvid was eligible for patent challenges on April 6, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 30, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AMYVID
International Patents:49
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 5
Clinical Trials: 36
Patent Applications: 216
What excipients (inactive ingredients) are in AMYVID?AMYVID excipients list
DailyMed Link:AMYVID at DailyMed
Drug patent expirations by year for AMYVID
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AMYVID
Generic Entry Date for AMYVID*:
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 AMYVID

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

SponsorPhase
National Institute on Aging (NIA)N/A
Elisa KonofagouN/A
University of California, IrvinePhase 3

See all AMYVID clinical trials

Pharmacology for AMYVID

US Patents and Regulatory Information for AMYVID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avid Radiopharms Inc AMYVID florbetapir f-18 SOLUTION;INTRAVENOUS 202008-001 Apr 6, 2012 DISCN No No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Avid Radiopharms Inc AMYVID florbetapir f-18 SOLUTION;INTRAVENOUS 202008-002 Apr 6, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Avid Radiopharms Inc AMYVID florbetapir f-18 SOLUTION;INTRAVENOUS 202008-001 Apr 6, 2012 DISCN No No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>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 AMYVID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1999109 13C0034 France   Get Started for $10 PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109 C 2013 023 Romania   Get Started for $10 PRODUCT NAME: FLORBETAPIR(18F)4-[(1E)-2-(6-{2-[2-(2-[18F]FLUOROETOXI)ETOXI]ETOXI}PIRIDIN-3-IL)ETENIL]-N-METILBENZENAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/12/805; DATE OF NATIONAL AUTHORISATION: 20130114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/805; DATE OF FIRST AUTHORISATION IN EEA: 20130114
1999109 2013/028 Ireland   Get Started for $10 PRODUCT NAME: FLORBETAPIR (18F), OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/805 20130114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
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Medtronic
Mallinckrodt
McKesson

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