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Details for New Drug Application (NDA): 203085
» See Plans and Pricing
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) |
Paragraph IV (Patent) Challenges for 203085
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
STIVARGA | TABLET;ORAL | regorafenib | 203085 | 2016-09-27 |
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, 2020 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Apr 27, 2024 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Feb 25, 2020 | ||||||||
Regulatory Exclusivity Use: |
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