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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

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#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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