Details for New Drug Application (NDA): 202008
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NDA 202008 describes AMYVID, which is a drug marketed by Avid Radiopharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the AMYVID profile page.
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.
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? | |
| Patented Use: | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMER’S DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY | ||||||||
| Patent: | 8,506,929 | Patent Expiration: | Apr 30, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMER’S DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY | ||||||||
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? | |
| Patented Use: | PET TO ESTIMATE AMYLOID BETA NEURITIC PLAQUE DENSITY IN ADULTS WITH COGNITIVE IMPAIRMENT: -EVALUATION OF ALZHEIMER’S DISEASE AND OTHER CAUSES OF COGNITIVE DECLINE -SELECTION OF PATIENTS WHO ARE INDICATED FOR AMYLOID BETA-DIRECTED THERAPY | ||||||||
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