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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
UBS
Julphar
Cerilliant
Federal Trade Commission
Colorcon
Chinese Patent Office
Covington
Boehringer Ingelheim

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204285

« Back to Dashboard

NDA 204285 describes IMATINIB MESYLATE, which is a drug marketed by Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in four NDAs. It is available from ten suppliers. Additional details are available on the IMATINIB MESYLATE profile page.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 204285
Tradename:IMATINIB MESYLATE
Applicant:Teva Pharms Usa
Ingredient:imatinib mesylate
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204285
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 204285
Suppliers and Packaging for NDA: 204285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 204285 ANDA Teva Pharmaceuticals USA, Inc. 0093-7629 N 0093-7629-98
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 204285 ANDA Teva Pharmaceuticals USA, Inc. 0093-7630 N 0093-7630-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 4, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Aug 4, 2016TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Julphar
Moodys
Cantor Fitzgerald
Accenture
Deloitte
AstraZeneca
Fish and Richardson
Argus Health

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.