OLYSIO Drug Patent Profile

When do Olysio patents expire, and when can generic versions of Olysio launch?

Olysio is a drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and thirty-nine patent family members in forty-three countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Olysio

Olysio was eligible for patent challenges on November 22, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OLYSIO

International Patents:	139
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	7
Patent Applications:	698
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OLYSIO
DailyMed Link:	OLYSIO at DailyMed

See drug prices for OLYSIO

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

NDA:

205123

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.

Recent Clinical Trials for OLYSIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yale University	Phase 4
Stanford University	Phase 4
Alexion Pharmaceuticals	Phase 1

See all OLYSIO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OLYSIO

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OLYSIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No			Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No			Y	Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No				Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No				Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No			Y	Y

International Patents for OLYSIO

When does loss-of-exclusivity occur for OLYSIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Germany

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Luxembourg

Malaysia

Montenegro

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OLYSIO around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2322516
Eurasian Patent Organization	014584	ИНГИБИТОРЫ NS-3 СЕРИНОВОЙ ПРОТЕАЗЫ HCV (HCV NS-3 SERINE PROTEASE INHIBITORS)
European Patent Office	1713822	INHIBITEURS DE LA SERINE PROTEASE NS-3 DU VHC (HCV NS-3 SERINE PROTEASE INHIBITORS)
Spain	2342944
European Patent Office	2937339	Inhibiteurs macrocycliques du virus de l'hépatite C (Macrocylic inhibitors of hepatitis c virus)
Poland	1912999
Brazil	PI0506945	inibidores de serina protease ns-3 de hcv

Supplementary Protection Certificates for OLYSIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	204 5025-2014	Slovakia		FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
1912999	PA2014036,C1912999	Lithuania		PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999	C 2014 040	Romania		PRODUCT NAME: SIMEPREVIR SAU O SARE A ACESTUIA, INCLUSIV SIMEPREVIRSODIU; NATIONAL AUTHORISATION NUMBER: EU/1/14/924; DATE OF NATIONAL AUTHORISATION: 20140514; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/924; DATE OF FIRST AUTHORISATION IN EEA: 20140514
1713823	CR 2014 00059	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
1912999	CA 2014 00053	Denmark		PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
1912999	C01912999/01	Switzerland		PRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 63215 04.03.2015
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516