Details for New Drug Application (NDA): 218466
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NDA 218466 describes VIJOICE, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VIJOICE profile page.
The generic ingredient in VIJOICE is alpelisib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
The generic ingredient in VIJOICE is alpelisib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218466
Generic Entry Date for 218466*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULES;ORAL |
*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: 218466
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIJOICE | alpelisib | GRANULE;ORAL | 218466 | NDA | Novartis Pharmaceuticals Corporation | 0078-1175 | 0078-1175-51 | 28 PACKET in 1 CARTON (0078-1175-51) / 1 GRANULE in 1 PACKET (0078-1175-19) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 50MG/PACKET | ||||
| Approval Date: | Apr 24, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 17, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY AND IS NOT RESPONSIVE TO RAPAMYCIN | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 17, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 29, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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