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Serving 500+ biopharmaceutical companies globally:

McKesson
Citi
Argus Health
Express Scripts
Farmers Insurance
Fuji
QuintilesIMS
Moodys
Baxter
Queensland Health

Generated: August 16, 2017

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Simeprevir sodium - Generic Drug Details

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What are the generic drug sources for simeprevir sodium and what is the scope of simeprevir sodium patent protection?

Simeprevir sodium
is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simeprevir sodium has one hundred and sixteen patent family members in thirty-nine countries.

There is one drug master file entry for simeprevir sodium. One supplier is listed for this compound.

Summary for Generic Name: simeprevir sodium

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list12
Clinical Trials: see list2,420
Patent Applications: see list53
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:simeprevir sodium 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► Subscribe► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► SubscribeY ► 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
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Non-Orange Book Patents for Generic Ingredient: simeprevir sodium

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 Ingredient: simeprevir sodium

Country Document Number Estimated Expiration
European Patent Office1912999► Subscribe
Japan2009502889► Subscribe
South Africa200800857► Subscribe
Luxembourg92568► Subscribe
EcuadorSP066726► 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: SIMEPREVIR SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
2014 00059Denmark► SubscribePRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
00697Netherlands► SubscribePRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
2014 00053Denmark► SubscribePRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Healthtrust
McKinsey
Covington
Dow
US Department of Justice
Chinese Patent Office
Daiichi Sankyo
Accenture
Teva

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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