Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Farmers Insurance
US Department of Justice
Merck
Cipla
McKinsey
Healthtrust
Argus Health
UBS

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021248

« 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. There are six patents protecting this drug and one Paragraph IV challenge. 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. One supplier is 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:6
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 N 63459-600-10
TRISENOX arsenic trioxide INJECTABLE;INJECTION 021248 NDA Cephalon, Inc. 63459-601 N 63459-601-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Sep 25, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 10, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:IN COMBINATION WITH TRETINOIN, TREATING ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-A GENE EXPRESSION
Patent:➤ Try a Free TrialPatent Expiration:Nov 10, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHO ARE REFRACTORY TO, OR HAVE RELAPSED FROM, RETINOID AND ANTHRACYCLINE CHEMOTHERAPY, AND WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION
Patent:➤ Try a Free TrialPatent Expiration:Nov 10, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Teva
US Army
Cipla
UBS
Farmers Insurance
AstraZeneca
Deloitte

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 verifification 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.