Details for New Drug Application (NDA): 212123
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NDA 212123 describes TAUVID, which is a drug marketed by Avid Radiopharms Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TAUVID profile page.
The generic ingredient in TAUVID is flortaucipir f-18. One supplier is listed for this compound. Additional details are available on the flortaucipir f-18 profile page.
The generic ingredient in TAUVID is flortaucipir f-18. One supplier is listed for this compound. Additional details are available on the flortaucipir f-18 profile page.
Summary for 212123
| Tradename: | TAUVID |
| Applicant: | Avid Radiopharms Inc |
| Ingredient: | flortaucipir f-18 |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212123
Generic Entry Date for 212123*:
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.
Suppliers and Packaging for NDA: 212123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAUVID | flortaucipir f-18 | SOLUTION;INTRAVENOUS | 212123 | NDA | Eli Lilly and Company | 0002-1220 | 0002-1220-48 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE |
| TAUVID | flortaucipir f-18 | SOLUTION;INTRAVENOUS | 212123 | NDA | Eli Lilly and Company | 0002-1220 | 0002-1220-50 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30ML (8.1-51mCi/ML) | ||||
| Approval Date: | May 28, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 26, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50ML (8.1-51mCi/ML) | ||||
| Approval Date: | May 28, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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