Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Citi
Express Scripts
Cerilliant
Chubb
UBS
McKinsey
US Department of Justice
Dow

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203085

« Back to Dashboard

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 five 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:5
Generic Entry Opportunity Date for 203085
Generic Entry Date for 203085*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 50419-171-00 210 BOTTLE in 1 BOX (50419-171-00) > 28 TABLET, FILM COATED in 1 BOTTLE
STIVARGA regorafenib TABLET;ORAL 203085 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-171 50419-171-03 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)

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.

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
US Department of Justice
Federal Trade Commission
Colorcon
Julphar
US Army
Cerilliant
Merck

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.