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Details for New Drug Application (NDA): 203085
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.
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
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 2C9 Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Sep 27, 2012 | TE: | 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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