Details for New Drug Application (NDA): 021923
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NDA 021923 describes NEXAVAR, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEXAVAR profile page.
The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Summary for 021923
| Tradename: | NEXAVAR |
| Applicant: | Bayer Hlthcare |
| Ingredient: | sorafenib tosylate |
| Patents: | 2 |
Pharmacology for NDA: 021923
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 021923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-488 | 50419-488-58 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58) |
| NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-489 | 50419-489-01 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Dec 20, 2005 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 24, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA. | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADVANCED RENAL CELL CARCINOMA | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA REFRACTORY TO RADIOACTIVE IODINE TREATMENT | ||||||||
Expired US Patents for NDA 021923
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
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