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Last Updated: July 12, 2020

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OLYSIO Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Olysio

Olysio was eligible for patent challenges on November 22, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 5, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OLYSIO
Drug patent expirations by year for OLYSIO
Drug Prices for OLYSIO

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Generic Entry Opportunity Date for OLYSIO
Generic Entry Date for OLYSIO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OLYSIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPhase 4
Stanford UniversityPhase 4
Yale UniversityPhase 4

See all OLYSIO clinical trials

US Patents and Regulatory Information for OLYSIO

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;ORAL 205123-001 Nov 22, 2013 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OLYSIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713823 CA 2014 00059 Denmark   Start Trial PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140514
1912999 C300697 Netherlands   Start Trial PRODUCT NAME: SIMEPREVIR, OF EEN ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999 122014000098 Germany   Start Trial PRODUCT NAME: SIMEPREVIR ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/924 20140514
1713823 CR 2014 00059 Denmark   Start Trial PRODUCT NAME: SIMEPREVIR ELLER ET FARMACEUTISK SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
AstraZeneca
Medtronic
Express Scripts
Baxter

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 verification 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.