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.

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:	⤷ Sign Up	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:	⤷ Sign Up	Patent Expiration:	Sep 10, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADVANCED RENAL CELL CARCINOMA
Patent:	⤷ Sign Up	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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