Viewing data from:

VIJOICE

NDA

ALPELISIB | N218466 | NOVARTIS PHARMACEUTICALS CORP

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Apr. 29, 2033

Sep. 10, 2029

Feb. 17, 2037

Feb. 17, 2037

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SCINOPHARM TAIWAN LTDALPELISIB

DMF 407082024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 23, 2025	SUPPL -1	View Letter (PDF)
Apr 25, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/PACKET

RLD

4 patents0 exclusivities▴

GRANULE;ORAL | Approved: Apr 24, 2024

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8227462	Apr 29, 2033	—	Yes	Yes	—	—
8476268	Sep 10, 2029	—	Yes	Yes	—	—
11433059	Feb 17, 2037	—	—	—		—
12427141	Feb 17, 2037	—	—	—		—