Details for New Drug Application (NDA): 218466

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 three 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.

Summary for 218466

Tradename:	VIJOICE
Applicant:	Novartis
Ingredient:	alpelisib
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 218466

Constraining patent/regulatory exclusivity:

8,227,462

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	GRANULES;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:	GRANULES;ORAL			Strength	50MG/PACKET
Approval Date:	Apr 24, 2024	TE:		RLD:	Yes
Patent:	12,427,141	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:	8,227,462	Patent Expiration:	Apr 29, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,476,268	Patent Expiration:	Sep 10, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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