Last Updated: August 3, 2026

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 eight 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:	8

Medical Subject Heading (MeSH) Categories for 205123

Antiviral Agents
Protease Inhibitors

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
Patent:	⤷ Start Trial	Patent Expiration:	Sep 5, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING HEPATITIS C
Patent:	⤷ Start Trial	Patent Expiration:	Jul 28, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING HEPATITIS C
Patent:	⤷ Start Trial	Patent Expiration:	Jul 28, 2026	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING HEPATITIS C

Expired US Patents for NDA 205123

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013	⤷ Start Trial	⤷ Start Trial
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013	⤷ Start Trial	⤷ Start Trial
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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