Details for New Drug Application (NDA): 215039
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NDA 215039 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 215039
Generic Entry Date for 215039*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY Dosage:
TABLET;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: 215039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIJOICE | alpelisib | TABLET;ORAL | 215039 | NDA | Novartis Pharmaceuticals Corporation | 0078-1021 | 0078-1021-84 | 1 BLISTER PACK in 1 CARTON (0078-1021-84) / 28 TABLET in 1 BLISTER PACK (0078-1021-51) |
| VIJOICE | alpelisib | TABLET;ORAL | 215039 | NDA | Novartis Pharmaceuticals Corporation | 0078-1021 | 0078-1021-91 | 1 BLISTER PACK in 1 CARTON (0078-1021-91) / 28 TABLET in 1 BLISTER PACK (0078-1021-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 5, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 5, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY | ||||||||
| 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 | ||||||||
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