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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.
Generic Entry Opportunity Date for 021923
*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 Action||Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 021923
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET;ORAL||Strength||EQ 200MG BASE|
|Approval Date:||Dec 20, 2005||TE:||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:||Start Trial||Patent Expiration:||Jan 12, 2020||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patent:||Start Trial||Patent Expiration:||Jan 12, 2020||Product Flag?||Substance Flag?||Y||Delist Request?|
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