Details for New Drug Application (NDA): 215039
✉ Email this page to a colleague
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 two patents protecting this drug. Additional details are available on the VIJOICE profile page.
The generic ingredient in VIJOICE is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
The generic ingredient in VIJOICE is alpelisib. 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:
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: | May 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| 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: | ⤷ Subscribe | Patent Expiration: | Apr 29, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Complete Access Available with Subscription
