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Last Updated: November 8, 2024

OLYSIO Drug Patent Profile


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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

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Summary for OLYSIO
Drug patent expirations by year for OLYSIO
Drug Prices for OLYSIO

See drug prices for OLYSIO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OLYSIO
Generic Entry Date for OLYSIO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Stanford UniversityPhase 4
Yale UniversityPhase 4
Achillion PharmaceuticalsPhase 1

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

OLYSIO is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OLYSIO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

HCV NS-3 serine protease inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocylic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING HEPATITIS C

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

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)

Patent: 06
Patent: Macrocydic inhibitors of hepatitis C virus.
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 5359
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Patent: 9345
Patent: INHIBIDORES MACROCÍCLICOS DEL VIRUS DE LA HEPATITIS C, COMPOSICIONES FARMACÉUTICAS QUE LOS COMPRENDEN, USO DE LOS MISMOS Y PROCESO PARA PREPARARLOS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 06274865
Patent: Macrocyclic inhibitors of hepatitis C virus
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 94288
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0614654
Patent: inibidores macrocìclicos de vìrus de hepatite c
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 16580
Patent: INHIBITEURS MACROCYCLIQUES DU VIRUS DE L'HEPATITE C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1228169
Patent: Macrocyclic inhibitors of hepatitis c virus
Estimated Expiration: ⤷  Sign Up

Patent: 2627639
Patent: Macrocydic inhibitors of hepatitis c virus.
Estimated Expiration: ⤷  Sign Up

Patent: 3030636
Patent: Macrocyclic inhibitors of hepatitis c virus
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 83
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0110237
Estimated Expiration: ⤷  Sign Up

Patent: 0151326
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 12006
Estimated Expiration: ⤷  Sign Up

Patent: 17392
Estimated Expiration: ⤷  Sign Up

Patent: 14044
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 12999
Estimated Expiration: ⤷  Sign Up

Patent: 22516
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 088150
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

El Salvador

Patent: 08002642
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE HEPATITIS C REF. PIT 111 SLV
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5131
Patent: МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 0800476
Patent: МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 12999
Patent: INHIBITEURS MACROCYCLIQUES DU VIRUS DE L'HÉPATITE C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 22516
Patent: Composés intermédiaires pour la préparation d'inhibiteurs macrocycliques du virus de l'hépatite C (Intermediates for the preparation of Macrocyclic inhibitors of hepatitis c virus)
Estimated Expiration: ⤷  Sign Up

Patent: 37339
Patent: Inhibiteurs macrocycliques du virus de l'hépatite C (Macrocylic inhibitors of hepatitis c virus)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2006019439
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 0600339
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 08000134
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 16771
Patent: MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Patent: 83872
Patent: 丙型肝炎病毒的大環抑制劑 (MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27156
Estimated Expiration: ⤷  Sign Up

Patent: 400054
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8227
Patent: תרכובות מקרוציקליות, שילובים ותכשירים רוקחיים המכילים אותן, שימושים בהן כמעכבי וירוס הפטיטיס c ותהליכים להכנתן (Macrocyclic compounds, combinations and pharmaceutical compositions comprising them, uses thereof as inhibitors of hepatitis c virus and processes for their preparation)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 97067
Estimated Expiration: ⤷  Sign Up

Patent: 09502889
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 568
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4217
Patent: MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 231
Patent: Makrociklički inhibitori virusa hepatitisa C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 415
Patent: Intermedijari za pripremu makrocikličkih inhibitora virusa hepatitisa C (Intermediates for the preparation of Macrocyclic inhibitors of hepatitis c virus)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4550
Patent: Macrocyclic inhibitors of hepatitis C virus
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 0800036
Patent: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 2393
Estimated Expiration: ⤷  Sign Up

Patent: 081073
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 070211
Patent: COMPUESTOS MACROCICLICOS COMO INHIBIDORES DEL VIRUS DE HEPATITIS C
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 12999
Estimated Expiration: ⤷  Sign Up

Patent: 22516
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 12999
Estimated Expiration: ⤷  Sign Up

Patent: 22516
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 743
Patent: MAKROCIKLIČKI INHIBITORI VIRUSA HEPATITISA C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Patent: 473
Patent: INTERMEDIJARI ZA DOBIJANJE MAKROCIKLIČNIH INHIBITORA VIRUSA HEPATITISA C (INTERMEDIATES FOR THE PREPARATION OF MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3617
Patent: MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 12999
Estimated Expiration: ⤷  Sign Up

Patent: 22516
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0800857
Patent: MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1059419
Estimated Expiration: ⤷  Sign Up

Patent: 080042084
Patent: MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 60473
Estimated Expiration: ⤷  Sign Up

Patent: 55230
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 58411
Estimated Expiration: ⤷  Sign Up

Patent: 0745117
Patent: Macrocylic inhibitors of hepatitis C virus
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 245
Patent: МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С;МАКРОЦИКЛІЧНІ ІНГІБІТОРИ ВІРУСУ ГЕПАТИТУ С (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 703
Estimated Expiration: ⤷  Sign Up

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
Denmark 2322516 ⤷  Sign Up
Nicaragua 200600168 INHIBIDORES DE SERINA PROTEASA NS-3 DEL VHC ⤷  Sign Up
Malaysia 153011 HCV NS-3 SERINE PROTEASE INHIBITORS ⤷  Sign Up
Denmark 1912999 ⤷  Sign Up
Germany 602006019439 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OLYSIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713823 132014902308868 Italy ⤷  Sign Up PRODUCT NAME: SIMEPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESO IL SALE SODICO(OLYSIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/924, 20140516
1713823 300703 Netherlands ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1713823 C300703 Netherlands ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
1912999 14C0076 France ⤷  Sign Up PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1912999 C20140034 00151 Estonia ⤷  Sign Up PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.