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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.
Generic Entry Opportunity Date for 205123
*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.
Profile for product number 001
|Active Rx/OTC/Discontinued:||DISCN||Dosage:||CAPSULE;ORAL||Strength||EQ 150MG BASE|
|Approval Date:||Nov 22, 2013||TE:||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 Trial||Patent Expiration:||May 19, 2025||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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