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Serving leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Argus Health
Federal Trade Commission
Cantor Fitzgerald

Generated: January 18, 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
Applicant:Bayer Hlthcare
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 50419-171-04 1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Sep 27, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 27, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Sep 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 27, 2024
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
Boehringer Ingelheim
Argus Health

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