Details for New Drug Application (NDA): 216962
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NDA 216962 describes VYALEV, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VYALEV profile page.
The generic ingredient in VYALEV is foscarbidopa; foslevodopa. One supplier is listed for this compound. Additional details are available on the foscarbidopa; foslevodopa profile page.
The generic ingredient in VYALEV is foscarbidopa; foslevodopa. One supplier is listed for this compound. Additional details are available on the foscarbidopa; foslevodopa profile page.
Summary for 216962
| Tradename: | VYALEV |
| Applicant: | Abbvie |
| Ingredient: | foscarbidopa; foslevodopa |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216962
Generic Entry Date for 216962*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 216962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYALEV | foscarbidopa; foslevodopa | SOLUTION;SUBCUTANEOUS | 216962 | NDA | AbbVie Inc. | 0074-0501 | 0074-0501-01 | 7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) | ||||
| Approval Date: | Oct 16, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 16, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 21, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MOTOR FLUCTUATIONS IN ADULTS WITH ADVANCED PARKINSON'S DISEASE | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 21, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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