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Last Updated: November 5, 2024

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

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.
Patent:⤷  Sign UpPatent Expiration:Feb 16, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 2, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST), INCLUDING BUT NOT LIMITED TO PATIENTS PREVIOUSLY TREATED WITH IMATINIB AND PATIENTS WITH GIST HAVING RESISTANCE TO A KIT TYROSINE KINASE INHIBITOR

Expired US Patents for NDA 203085

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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