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Generated: November 15, 2018

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 eight 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:8
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021923
Generic Entry Date for 021923*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 20, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 22, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA (DCT) THAT IS REFRACTORY TO RADIOACTIVE IODINE TREATMENT.
Patent:➤ Try a Free TrialPatent Expiration:Jan 12, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 12, 2020Product Flag?Substance Flag?YDelist Request?

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