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Last Updated: September 21, 2021

DrugPatentWatch Database Preview

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. One supplier is 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 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)
Paragraph IV (Patent) Challenges for 021923
Tradename Dosage Ingredient NDA Submissiondate
NEXAVAR TABLET;ORAL sorafenib tosylate 021923 2014-02-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 20, 2005TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Feb 11, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADVANCED RENAL CELL CARCINOMA
Patent:⤷  Try it FreePatent 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 it FreePatent Expiration:Sep 10, 2028Product Flag?YSubstance 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 ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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