Viewing data from:

VIJOICE

NDA

ALPELISIB | N215039 | NOVARTIS PHARMACEUTICALS CORP

3 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

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

ODE-396

Apr. 5, 2029

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

Medicare Part D Spending

CMS annual spending data for Vijoice (2023)

Total Spending

$6.0M

Total Claims

125

Beneficiaries

Avg Cost/Unit

$1075.07

Spending Trend

$1.9M(2022)→$6.0M(2023)

YoY Change:+10.8%

5yr CAGR:+10.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

4 letters from Drugs@FDA

Date	Submission	Document
Jul 23, 2025	SUPPL -3	View Letter (PDF)
Apr 25, 2024	SUPPL -2	View Letter (PDF)
Nov 18, 2022	SUPPL -1	View Letter (PDF)
Apr 8, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 5, 2022

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	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-396	Apr 5, 2029	Active

#002 — 125MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 5, 2022

#003 — 200MG

RLD

4 patents1 exclusivity▾

TABLET;ORAL | Approved: Apr 5, 2022