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Serving 500+ biopharmaceutical companies globally:

Citi
Harvard Business School
Cantor Fitzgerald
Fish and Richardson
Colorcon
McKesson
Medtronic
Dow
Mallinckrodt
US Army

Generated: August 23, 2017

DrugPatentWatch Database Preview

OLYSIO Drug Profile

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Which patents cover Olysio, and what generic Olysio alternatives are available?

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

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

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the simeprevir sodium profile page.

Summary for Tradename: OLYSIO

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list11
Clinical Trials: see list6
Patent Applications: see list46
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OLYSIO at DailyMed
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;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: OLYSIO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,608,590HCV NS-3 serine protease inhibitors► Subscribe
8,153,800Macrocyclic inhibitors of hepatitis C virus► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: OLYSIO

Country Document Number Estimated Expiration
New Zealand548739► Subscribe
TaiwanI361195► Subscribe
South Korea101059419► Subscribe
Japan2014055161► Subscribe
Japan2007524670► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLYSIO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140034 00151Estonia► SubscribePRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
2014 00059Denmark► SubscribePRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
4 5025-2014Slovakia► SubscribePRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924/001 - EU/1/14/924/002 20140516
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
Federal Trade Commission
UBS
Merck
Johnson and Johnson
Fish and Richardson
Cipla
US Army
Teva
Farmers Insurance

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 verifification 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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