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OLYSIO Drug Profile

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Which patents cover Olysio, and what substitute generic drugs are available?

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

This drug has one hundred and ten 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:7
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes8,349,869► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes7,671,032► SubscribeYY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes8,741,926► SubscribeY ► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► Subscribe► Subscribe
Janssen Prods
OLYSIO
simeprevir sodium
CAPSULE;ORAL205123-001Nov 22, 2013RXYesYes► 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
Israel176921► Subscribe
Costa Rica8540► Subscribe
Eurasian Patent Organization200800476► Subscribe
Luxembourg92595► Subscribe
Germany602006019439► 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
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
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
0140034 00151Estonia► SubscribePRODUCT NAME: SIMEPREVIIR;REG NO/DATE: EU/1/14/924 16.05.2014
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
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