Generated: December 16, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203341
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, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BOSULIF profile page.
The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.
Summary for 203341
Pharmacology for NDA: 203341
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET;ORAL||Strength||EQ 100MG BASE|
|Approval Date:||Sep 4, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Sep 4, 2017
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Sep 4, 2019
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Mar 27, 2018||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patented Use:||A METHOD OF TREATING A NEOPLASM|
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