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Boehringer Ingelheim
Johnson and Johnson
Colorcon
Argus Health
AstraZeneca
Farmers Insurance
Accenture
Julphar
Cerilliant

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203085

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NDA 203085 describes STIVARGA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STIVARGA profile page.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.
Summary for 203085
Tradename:STIVARGA
Applicant:Bayer Hlthcare
Ingredient:regorafenib
Patents:4
Pharmacology for NDA: 203085
Suppliers and Packaging for NDA: 203085
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STIVARGA regorafenib TABLET;ORAL 203085 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-171 N 50419-171-00
STIVARGA regorafenib TABLET;ORAL 203085 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-171 N 50419-171-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Sep 27, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 27, 2024
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC OR LIVER CANCER) WHO HAVE BEEN PREVIOUSLY TREATED WITH THE DRUG SORAFENIB.
Regulatory Exclusivity Expiration:Apr 27, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Regulatory Exclusivity Expiration:Feb 25, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH IMATINIB MESYLATE AND SUNITINIB MALATE.

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Citi
Chinese Patent Office
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Covington
Queensland Health
Teva
QuintilesIMS
US Army

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