Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Daiichi Sankyo
QuintilesIMS
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Fish and Richardson
Medtronic
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Generated: September 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205123

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NDA 205123 describes OLYSIO, which is a drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this drug. Additional details are available on the OLYSIO profile page.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. Additional details are available on the simeprevir sodium profile page.
Summary for 205123
Tradename:OLYSIO
Applicant:Janssen Prods
Ingredient:simeprevir sodium
Patents:9
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205123
Generic Entry Date for 205123*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.

Medical Subject Heading (MeSH) Categories for 205123

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Nov 22, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 26, 2019
Regulatory Exclusivity Use:UPDATES TO LABELING WITH RESULTS TO THE TIGER CLINICAL TRIAL
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:UPDATES TO THE PRODUCT LABELING WITH STUDY REPORTS FROM THE OPTIMIST-1 AND OPTIMIST-2 CLINICAL TRIALS
Patent:  Try a Free TrialPatent Expiration:May 19, 2025Product Flag?YSubstance Flag?YDelist Request?

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AstraZeneca
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Fuji
US Department of Justice
Merck
Cantor Fitzgerald

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