OLYSIO Drug Patent Profile
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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
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Questions you can ask:
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Summary for OLYSIO
| International Patents: | 139 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 7 |
| Patent Applications: | 696 |
| Drug Prices: | Drug price information for OLYSIO |
| DailyMed Link: | OLYSIO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OLYSIO
*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 |
|---|---|
| Stanford University | Phase 4 |
| Yale University | Phase 4 |
| Achillion Pharmaceuticals | Phase 1 |
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 |
|---|---|---|---|
| Croatia | P20110237 | ⤷ Sign Up | |
| Slovenia | 2322516 | ⤷ Sign Up | |
| Sweden | 0402562 | ⤷ Sign Up | |
| Singapore | 163617 | MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS | ⤷ Sign Up |
| Israel | 188227 | 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) | ⤷ 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 | 92595 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1912999 | C20140034 00151 | Estonia | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014 |
| 1912999 | PA2014036 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 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 |
| 1713823 | CA 2014 00059 | Denmark | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514 |
| >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.
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