Viewing data from:

XALKORI

NDA

CRIZOTINIB | N202570 | PF PRISM CV

2 strengths3 unique patents2 unique exclusivities

Patent Timeline

3 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (2)TodayExclusivity

2027

2028

2029

2030

Today

7825137

May. 12, 2027

7858643

Oct. 8, 2029

8217057

Nov. 6, 2029

ODE-328

Jan. 14, 2028

ODE-407

Jul. 14, 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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Crizotinib for ROS1 and MET Activated Lung Cancer NCT04084717	Phase 2	Completed	University Health Network, Toronto	33	2019-12-03 → 2024-12-30
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)NCT02838420	Phase 3	Completed	Hoffmann-La Roche	187	2016-08-03 → 2026-05-11

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

Medicare Part D Spending

CMS annual spending data for Xalkori (2023)

Total Spending

$52.1M

Total Claims

2,603

Beneficiaries

387

Avg Cost/Unit

$374.20

Spending Trend

$66.8M(2019)→$62.6M(2020)→$53.0M(2021)→$58.6M(2022)→$52.1M(2023)

YoY Change:+8.7%

5yr CAGR:+6.7%

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

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDCRIZOTINIB

DMF 381082023

NAVINTA LLCCRIZOTINIB

DMF 393252024

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDCRIZOTINIB

DMF 400332024

HETERO LABS LTDCRIZOTINIB

DMF 412712025

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Sep 8, 2023	SUPPL -36	View Letter (PDF)
Jul 15, 2022	SUPPL -33	View Letter (PDF)
Jan 19, 2021	SUPPL -30	View Letter (PDF)
Jun 26, 2019	SUPPL -28	View Letter (PDF)
Dec 20, 2018	ORIG -1	View Letter (PDF)
Dec 7, 2018	SUPPL -26	View Letter (PDF)
Dec 7, 2018	SUPPL -27	View Letter (PDF)
Feb 8, 2018	SUPPL -24	View Letter (PDF)
Feb 8, 2018	SUPPL -23	View Letter (PDF)
Jul 25, 2017	SUPPL -21	View Letter (PDF)
May 2, 2017	SUPPL -19	View Letter (PDF)
Jan 27, 2017	SUPPL -20	View Letter (PDF)
Oct 28, 2016	SUPPL -16	View Letter (PDF)
May 4, 2016	SUPPL -17	View Letter (PDF)
May 2, 2016	SUPPL -18	View Letter (PDF)
Sep 16, 2015	SUPPL -14	View Letter (PDF)
Mar 24, 2015	SUPPL -13	View Letter (PDF)
Jun 2, 2014	SUPPL -11	View Letter (PDF)
Nov 25, 2013	SUPPL -6	View Letter (PDF)
Oct 8, 2013	SUPPL -9	View Letter (PDF)
Oct 8, 2013	SUPPL -7	View Letter (PDF)
Mar 1, 2013	SUPPL -4	View Letter (PDF)
Feb 29, 2012	SUPPL -2	View Letter (PDF)
Feb 29, 2012	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG

RLD

3 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Aug 26, 2011

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7825137	May 12, 2027	—	—	—		—
7858643	Oct 8, 2029	—	Yes	Yes	—	—
8217057	Nov 6, 2029	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
ODE-328	Jan 14, 2028	Active
ODE-407	Jul 14, 2029	Active

#002 — 250MG

RLD

3 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Aug 26, 2011