Viewing data from:

PIQRAY

NDA

ALPELISIB | N212526 | NOVARTIS PHARMACEUTICALS CORP

3 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

8227462

Apr. 29, 2033

8476268

Sep. 10, 2029

I-937

Jan. 18, 2027

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

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.NCT05948943	Phase 2/3	Recruiting	Novartis Pharmaceuticals	232	2023-11-24 → 2033-05-02
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)NCT06997588	Phase 2	Recruiting	Novartis Pharmaceuticals	104	2025-10-09 → 2030-09-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Piqray (2023)

Total Spending

$138.4M

Total Claims

6,641

Beneficiaries

1,673

Avg Cost/Unit

$461.12

Spending Trend

$46.0M(2019)→$145.6M(2020)→$124.1M(2021)→$122.2M(2022)→$138.4M(2023)

YoY Change:+6.1%

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

6 letters from Drugs@FDA

Date	Submission	Document
Jan 19, 2024	SUPPL -9	View Letter (PDF)
Nov 25, 2022	SUPPL -7	View Letter (PDF)
May 5, 2022	SUPPL -6	View Letter (PDF)
Jul 22, 2021	SUPPL -4	View Letter (PDF)
Sep 2, 2020	SUPPL -1	View Letter (PDF)
Jun 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: May 24, 2019

Patents (2)

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

Exclusivities (1)

Code	Date	Status
I-937	Jan 18, 2027	< 1 year

#002 — 150MG

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: May 24, 2019

#003 — 200MG

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: May 24, 2019