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Simeprevir sodium - Generic Drug Details

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

This ingredient has one hundred and eight patent family members in thirty-eight 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:7
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYes► subscribe► subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYes9,353,103► subscribe ► subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYes8,741,926► 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
8,153,800Macrocyclic inhibitors of hepatitis C virus► subscribe
7,608,590HCV NS-3 serine protease inhibitors► 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
Taiwan200538449► subscribe
Israel188227► subscribe
Eurasian Patent Organization014584► 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
595Luxembourg► subscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
4 5025-2014Slovakia► subscribePRODUCT NAME: SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924/001 - EU/1/14/924/002 20140516
2014036Lithuania► subscribePRODUCT NAME: SIMEPREVIRUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
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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 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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