You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

OLYSIO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

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
Yale UniversityPhase 4
Stanford 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocylic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING HEPATITIS C

Macrocyclic inhibitors of hepatitis C virus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 5359
Estimated Expiration: ⤷  Try a Trial

Patent: 9345
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06274865
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 94288
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0614654
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 16580
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1228169
Estimated Expiration: ⤷  Try a Trial

Patent: 2627639
Estimated Expiration: ⤷  Try a Trial

Patent: 3030636
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 83
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0110237
Estimated Expiration: ⤷  Try a Trial

Patent: 0151326
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12006
Estimated Expiration: ⤷  Try a Trial

Patent: 17392
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 12999
Estimated Expiration: ⤷  Try a Trial

Patent: 22516
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088150
Estimated Expiration: ⤷  Try a Trial

El Salvador

Patent: 08002642
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5131
Estimated Expiration: ⤷  Try a Trial

Patent: 0800476
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 12999
Estimated Expiration: ⤷  Try a Trial

Patent: 22516
Estimated Expiration: ⤷  Try a Trial

Patent: 37339
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2006019439
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0600339
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 08000134
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 16771
Estimated Expiration: ⤷  Try a Trial

Patent: 83872
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27156
Estimated Expiration: ⤷  Try a Trial

Patent: 400054
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8227
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 97067
Estimated Expiration: ⤷  Try a Trial

Patent: 09502889
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 568
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4217
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 231
Estimated Expiration: ⤷  Try a Trial

Patent: 415
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4550
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0800036
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 2393
Estimated Expiration: ⤷  Try a Trial

Patent: 081073
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 070211
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 12999
Estimated Expiration: ⤷  Try a Trial

Patent: 22516
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 12999
Estimated Expiration: ⤷  Try a Trial

Patent: 22516
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 743
Estimated Expiration: ⤷  Try a Trial

Patent: 473
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3617
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 12999
Estimated Expiration: ⤷  Try a Trial

Patent: 22516
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0800857
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1059419
Estimated Expiration: ⤷  Try a Trial

Patent: 080042084
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 60473
Estimated Expiration: ⤷  Try a Trial

Patent: 55230
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 58411
Estimated Expiration: ⤷  Try a Trial

Patent: 0745117
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 245
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 703
Estimated Expiration: ⤷  Try a Trial

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
Canada 2552317 INHIBITEURS DE LA SERINE PROTEASE NS-3 DU VHC (HCV NS-3 SERINE PROTEASE INHIBITORS) ⤷  Try a Trial
Ecuador SP066725 INHIBIDORES DE SERINA PROTEASA NS-3 DEL VHC ⤷  Try a Trial
Serbia 54473 INTERMEDIJARI ZA DOBIJANJE MAKROCIKLIČNIH INHIBITORA VIRUSA HEPATITISA C (INTERMEDIATES FOR THE PREPARATION OF MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005073216 ⤷  Try a Trial
Croatia P20151326 ⤷  Try a Trial
China 102627639 Macrocydic inhibitors of hepatitis c virus. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OLYSIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713823 300703 Netherlands ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1912999 C01912999/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 63215 04.03.2015
1912999 204 5025-2014 Slovakia ⤷  Try a Trial FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
1912999 C20140034 00151 Estonia ⤷  Try a Trial PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
1713823 C300703 Netherlands ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
1912999 CR 2014 00053 Denmark ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.