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Serving leading biopharmaceutical companies globally:

Deloitte
Johnson and Johnson
Chubb
Baxter
Boehringer Ingelheim
Julphar
Daiichi Sankyo
Dow
Novartis
Harvard Business School

Generated: December 15, 2017

DrugPatentWatch Database Preview

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 twenty-seven patent family members in thirty-nine countries and fourteen supplementary protection certificates in nine countries.

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

Medical Subject Heading (MeSH) Categories for simeprevir sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsOLYSIOsimeprevir sodiumCAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► 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
Norway20063850► Subscribe
Luxembourg92595► Subscribe
CroatiaP20151326► Subscribe
Spain2555230► Subscribe
European Patent Office2937339► Subscribe
Canada2552317► Subscribe
South Korea20060126567► Subscribe
Canada2552319► Subscribe
Sweden0401288► Subscribe
Germany602005017582► 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
4 5025-2014Slovakia► SubscribeFORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
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
00703Netherlands► SubscribePRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
0703Netherlands► SubscribePRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
00697Netherlands► SubscribePRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
2014036Lithuania► SubscribePRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Deloitte
Chinese Patent Office
Colorcon
Cantor Fitzgerald
Fuji
UBS
US Department of Justice
Federal Trade Commission

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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