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Last Updated: November 8, 2024

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Patent:⤷  Sign UpPatent Expiration:May 19, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 5, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING HEPATITIS C
Patent:⤷  Sign UpPatent Expiration:Jul 28, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING HEPATITIS C

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.