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Last Updated: November 24, 2024

Simeprevir sodium - Generic Drug Details


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

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

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

Summary for simeprevir sodium
International Patents:139
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 46
Patent Applications: 1,708
DailyMed Link:simeprevir sodium at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for simeprevir sodium
Generic Entry Date for simeprevir sodium*:
Constraining patent/regulatory exclusivity:
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.

Medical Subject Heading (MeSH) Categories for simeprevir sodium

US Patents and Regulatory Information for simeprevir sodium

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

International Patents for simeprevir sodium

Country Patent Number Title Estimated Expiration
China 103030636 Macrocyclic inhibitors of hepatitis c virus ⤷  Sign Up
Spain 2360473 ⤷  Sign Up
Denmark 1912999 ⤷  Sign Up
Malaysia 144217 MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS ⤷  Sign Up
Spain 2555230 ⤷  Sign Up
Poland 1713822 ⤷  Sign Up
Serbia 54473 INTERMEDIJARI ZA DOBIJANJE MAKROCIKLIČNIH INHIBITORA VIRUSA HEPATITISA C (INTERMEDIATES FOR THE PREPARATION OF MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for simeprevir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1912999 2014/058 Ireland ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1912999 PA2014036,C1912999 Lithuania ⤷  Sign Up PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514
1912999 CR 2014 00053 Denmark ⤷  Sign Up PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
1713823 122014000103 Germany ⤷  Sign Up PRODUCT NAME: SIMEPREVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH SIMEPREVIR NATRIUM; NAT. REGISTRATION NO/DATE: EU /1/14/924 20140514; FIRST REGISTRATION: EU EU/1/14/924 20140514
1713823 C300703 Netherlands ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, WAARONDER SIMEPREVIRNATRIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140514
1912999 204 5025-2014 Slovakia ⤷  Sign Up FORMER OWNER(S): JANSSEN R&D IRELAND, IE; MEDIVIR AB, SE; DATUM ZAPISU DO REGISTRA: 20161206
1912999 1490062-5 Sweden ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.