Details for New Drug Application (NDA): 202008
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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.
Summary for 202008
Tradename: | AMYVID |
Applicant: | Avid Radiopharms Inc |
Ingredient: | florbetapir f-18 |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202008
Generic Entry Date for 202008*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 202008
Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 202008
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008 | NDA | Eli Lilly and Company | 0002-1200 | 0002-1200-48 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE |
AMYVID | florbetapir f-18 | SOLUTION;INTRAVENOUS | 202008 | NDA | Eli Lilly and Company | 0002-1200 | 0002-1200-50 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10ML (13.5-51mCi/ML) | ||||
Approval Date: | Apr 6, 2012 | TE: | RLD: | Yes | |||||
Patent: | 7,687,052 | Patent Expiration: | Apr 30, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | 8,506,929 | Patent Expiration: | Apr 30, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10-30ML (13.5-51mCi/ML) | ||||
Approval Date: | Apr 6, 2012 | TE: | RLD: | Yes | |||||
Patent: | 7,687,052 | Patent Expiration: | Apr 30, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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