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 three 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. Six 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. Six 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: | 3 |
| Formulation / Manufacturing: | see details |
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) |
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: | See Plans and Pricing | Patent Expiration: | Feb 11, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED RENAL CELL CARCINOMA | ||||||||
| Patent: | See Plans and Pricing | 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: | See Plans and Pricing | Patent Expiration: | Sep 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADVANCED RENAL CELL CARCINOMA | ||||||||
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 | See Plans and Pricing | See Plans and Pricing |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | See Plans and Pricing | See Plans and Pricing |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | See Plans and Pricing | See Plans and Pricing |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | See Plans and Pricing | See Plans and Pricing |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | See Plans and Pricing | See Plans and Pricing |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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