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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-eight 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.
US ANDA Litigation and 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
Summary for AMYVID
| International Patents: | 48 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 3 |
| Clinical Trials: | 35 |
| Patent Applications: | 7 |
| DailyMed Link: | AMYVID at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Elisa Konofagou | N/A |
| National Institute on Aging (NIA) | N/A |
| University of California, Irvine | Phase 3 |
Pharmacology for AMYVID
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-002 | Apr 6, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-001 | Apr 6, 2012 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-002 | Apr 6, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-003 | Apr 6, 2012 | RX | Yes | Yes | 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 |
International Patents for AMYVID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2363392 | Start Trial |
| Costa Rica | 10329 | Start Trial |
| Israel | 193567 | Start Trial |
| Norway | 2018030 | Start Trial |
| New Zealand | 570887 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMYVID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1999109 | 481 | Finland | Start Trial | |
| 1999109 | 2013/028 | Ireland | Start Trial | PRODUCT NAME: FLORBETAPIR (18F), OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/805 20130114 |
| 1999109 | SPC/GB13/040 | United Kingdom | Start Trial | PRODUCT NAME: FLORBETAPIR (18F) ((E)-4-(2-(6-(2-(2-(2-((18F)-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL)VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR (18F); REGISTERED: UK EU/1/12/805 20130117 |
| 1999109 | C20130016 00076 | Estonia | Start Trial | PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013 |
| 1999109 | 139 5017-2013 | Slovakia | Start Trial | PRODUCT NAME: FLORBETAPIR ( 18 F); REGISTRATION NO/DATE: EU/1/12/805 20130114 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
