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Last Updated: March 29, 2024

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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021923
Mechanism of ActionProtein 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:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 20, 2005TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 24, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA.
Patent:⤷  Try a TrialPatent Expiration:Sep 10, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ADVANCED RENAL CELL CARCINOMA
Patent:⤷  Try a TrialPatent Expiration:Sep 10, 2028Product Flag?YSubstance 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 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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