Viewing data from:

TRISENOX

NDA

ARSENIC TRIOXIDE | N021248 | CEPHALON INC

2 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Cephalon, Inc. et al v. Fresenius Kabi USA, LLC 1:2015cv01074 4 patentsANDA 208231arsenic trioxide	D. Del.	2015-11-19	Terminated 2016-08-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Lachman Consultant Services, Inc. FDA-2018-P-3949 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Cephalon Inc's TRISENOX (Arsenic Trioxide) Injection, 1mg/mL, approved under NDA N021248, was discontinued for safety or effectiveness reasons. If the FDA determines the discontinuat	505(q)	2018-10-18	Granted	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

115 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 58 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia NCT02339740	Phase 3	Active	Children's Oncology Group	158	2015-07-21 → 2029-06-30
Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma NCT03503864	Phase 2	Active	Yang Li	80	2017-06-12 → 2028-12-30
Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia NCT03031249	Phase 1/2	By Invitation	Institute of Hematology & Blood Diseases Hospital, China	80	2017-02-08 → 2027-10-15
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia NCT01409161	Phase 2	Recruiting	M.D. Anderson Cancer Center	151	2011-10-05 → 2027-12-18
Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia NCT00005795	Phase 2	Completed	Northwestern University	11	2000-02 → 2002-07
Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia NCT00258245	Phase 1	Completed	Barbara Ann Karmanos Cancer Institute	5	2005-05 → 2008-04
Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis NCT00572065	Early Phase 1	Completed	Weill Medical College of Cornell University	21	2008-02-29 → 2010-02-08
Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma NCT00720564	Phase 1	Completed	City of Hope Medical Center	18	2008-04 → 2009-02
Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer NCT00003395	Phase 1	Completed	Memorial Sloan Kettering Cancer Center	—	1998-04 → 2000-03
Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide NCT02966301	Phase 2	Completed	Medsenic	21	2016-12 → 2020-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$0.01

Highest Price

$4060.80

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63459-0601-06TRISENOX 2MG/ML INJ	$4060.80	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
63459-0601-06TRISENOX 2MG/ML INJ	$0.01	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Arsenic Trioxide (2024)

Total Spending

$1.3M

Total Claims

6,002

Beneficiaries

177

ASP Price

$11.39

Spending Trend

$6.8M(2019)→$2.9M(2020)→$1.7M(2021)→$1.3M(2022)→$1.8M(2023)→$1.3M(2024)

YoY Change:-25.0%

5yr CAGR:-21.2%

HCPCS: J9017 — Injection, arsenic trioxide, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain5 active DMFs2 inactive

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

HERAEUS PRECIOUS METALS GMBH AND CO KGARSENIC TRIOXIDE USP

DMF 200332006

CHEMWERTH INCARSENIC TRIOXIDE

DMF 260752012

UMICORE ARGENTINA SAARSENIC TRIOXIDE

DMF 313252017

EMCURE PHARMACEUTICALS LTDARSENIC TRIOXIDE

DMF 334532019

CHEMCON GMBHARSENIC TRIOXIDE

DMF 337582019

TTY BIOPHARM CO LTDInactiveArsenic Trioxide

DMF 210922007

CADILA HEALTHCARE LTDInactiveARSENIC TRIOXIDE

DMF 273822013

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2020	SUPPL -19	View Letter (PDF)
Jun 21, 2019	SUPPL -18	View Letter (PDF)
Jan 17, 2018	SUPPL -15	View Letter (PDF)
Feb 24, 2015	SUPPL -13	View Letter (PDF)
Jul 28, 2010	SUPPL -8	View Letter (PDF)
Jul 28, 2010	SUPPL -9	View Letter (PDF)
Sep 25, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 25, 2000

No patent or exclusivity listings for this strength.

#002 — 2MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 13, 2017