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Last Updated: February 26, 2021

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SIVEXTRO Drug Profile

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When do Sivextro patents expire, and what generic alternatives are available?

Sivextro is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this drug.

This drug has seventy-seven patent family members in thirty-nine countries.

The generic ingredient in SIVEXTRO is tedizolid phosphate. One supplier is listed for this compound. Additional details are available on the tedizolid phosphate profile page.

US ANDA Litigation and Generic Entry Outlook for Sivextro

Sivextro was eligible for patent challenges on June 20, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 31, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

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Generic Entry Opportunity Date for SIVEXTRO
Generic Entry Dates for SIVEXTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for SIVEXTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 SIVEXTRO

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

SponsorPhase
Los Angeles Biomedical Research InstitutePhase 2
Merck Sharp & Dohme Corp.Phase 1
Hartford HospitalPhase 1

See all SIVEXTRO clinical trials

Pharmacology for SIVEXTRO

US Patents and Regulatory Information for SIVEXTRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   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 SIVEXTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 CA 2015 00048 Denmark   Start Trial PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TEDIZOLID PHOSPHATE; REG. NO/DATE: EU/1/15/991 20150325
1699784 SPC/GB15/056 United Kingdom   Start Trial PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/15/991 20150325
1699784 PA2015032,C1699784 Lithuania   Start Trial PRODUCT NAME: TEDIZOLIDAS, PASIRINKTINAI ESTERIO PAVIDALU, YPAC FOSFATO ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 1590047-5 Sweden   Start Trial PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/991 20150325
1699784 C01699784/01 Switzerland   Start Trial PRODUCT NAME: TEDIZOLID; REGISTRATION NO/DATE: SWISSMEDIC 65270 05.01.2016
1699784 C 2015 035 Romania   Start Trial PRODUCT NAME: TEDIZOLIDOPTIONAL SUB FORMA DE ESTER, IN PARTICULAR FOSFATUL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/991; DATE OF NATIONAL AUTHORISATION: 20150323; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/991; DATE OF FIRST AUTHORISATION IN EEA: 20150323
1699784 122015000078 Germany   Start Trial PRODUCT NAME: TEDIZOLID, GEGEBENENFALLS IN FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/991/001-003 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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AstraZeneca
Moodys
Baxter
McKesson

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