Florbetapir f-18 - Generic Drug Details
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What are the generic sources for florbetapir f-18 and what is the scope of freedom to operate?
Florbetapir f-18
is the generic ingredient in one branded drug marketed by Avid Radiopharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Florbetapir f-18 has fifty-one patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for florbetapir f-18
| International Patents: | 51 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 11 |
| Clinical Trials: | 47 |
| DailyMed Link: | florbetapir f-18 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for florbetapir f-18
*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 florbetapir f-18
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad Central del Caribe | Phase 2 |
| University of Puerto Rico | Phase 2 |
| Neuroscience Trials Australia | Phase 2 |
Pharmacology for florbetapir f-18
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Positron Emitting Activity |
US Patents and Regulatory Information for florbetapir f-18
| 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 | 202008-002 | Apr 6, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-003 | Apr 6, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-001 | Apr 6, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-004 | Oct 13, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Avid Radiopharms Inc | AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008-001 | Apr 6, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 florbetapir f-18
Supplementary Protection Certificates for florbetapir f-18
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1999109 | C01999109/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014 |
| 1999109 | 92232 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: FLORBETAPIR (18 F) |
| 1999109 | C 2013 023 | Romania | ⤷ Sign Up | 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 | 481 | Finland | ⤷ Sign Up | |
| 1999109 | 2013/028 | Ireland | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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