➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Moodys
Merck
Johnson and Johnson
McKinsey

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021248


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021248 describes TRISENOX, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. Additional details are available on the TRISENOX profile page.

The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 021248
Tradename:TRISENOX
Applicant:Cephalon
Ingredient:arsenic trioxide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021248
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248 NDA Cephalon, Inc. 63459-600 63459-600-10 10 AMPULE in 1 CARTON (63459-600-10) > 10 mL in 1 AMPULE (63459-600-01)
TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248 NDA Cephalon, Inc. 63459-601 63459-601-06 10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) > 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)
Paragraph IV (Patent) Challenges for 021248
Tradename Dosage Ingredient NDA Submissiondate
TRISENOX INJECTABLE;INJECTION arsenic trioxide 021248 2015-08-11

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 25, 2000TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 12, 2025
Regulatory Exclusivity Use:ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Oct 13, 2017TE:APRLD:Yes
Regulatory Exclusivity Expiration:Jan 12, 2025
Regulatory Exclusivity Use:ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION

Expired US Patents for NDA 021248

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-002 Oct 13, 2017   Start Trial   Start Trial
Cephalon TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248-001 Sep 25, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Boehringer Ingelheim
Baxter
McKesson
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.