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^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 8,148,399 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

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:	7,671,032	Patent Expiration:	May 19, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,148,399	Patent Expiration:	Sep 5, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING HEPATITIS C
Patent:	8,349,869	Patent Expiration:	Jul 28, 2026	Product Flag?	Y	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	7,671,032	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

Summary for 205123

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205123

Medical Subject Heading (MeSH) Categories for 205123

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205123