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Last Updated: January 25, 2020

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SIVEXTRO Drug Profile

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Which patents cover Sivextro, 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

See drug prices for SIVEXTRO

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
Synonyms for SIVEXTRO
((5R)-3-(3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5- yl)methyl hydrogen phosphate
(R)-(3-(3-fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazol
(R)-(3-(3-fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-2-oxooxazolidin-5-yl)methyl dihydrogen phosphate
(R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyloxazolidin-2-one dihydrogenphosphate
[(5R)-3-[3-fluoro-4-[6-(2-methyltetrazol-5-yl)pyridin-3-yl]phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl dihydrogen phosphate
[(5R)-3-{3-fluoro-4-[6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl]phenyl}-2-oxo-1,3-oxazolidin-5-yl]methyl dihydrogen phosphate
2-Oxazolidinone, 3-(3-fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)-3-pyridinyl)phenyl)-5- ((phosphonooxy)methyl)-, (5R)-
856867-55-5
9050AF
AK176008
AKOS027250820
BCP10960
BDBM50017198
C17H16FN6O6P
CHEBI:83326
CHEMBL2105669
CS-5004
D09686
DB09042
DTXSID30234977
HY-14855B
idin-5-yl)methyl dihydrogen phosphate
KS-00000T77
MolPort-039-141-757
NCGC00482851-02
NE63553
O7DRJ6R4DW
s4641
SCHEMBL1557561
Sivextro (TN)
Tedizolid (phosphate)
Tedizolid phosphate
Tedizolid phosphate (JAN/USAN)
Tedizolid phosphate [USAN]
Torezolid phosphate
TR-701
TR-701 FA
TR-701-FA
TR-701FA
UNII-O7DRJ6R4DW
ZINC43100953

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 POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes   Start Trial   Start Trial Y   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 CR 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 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 C300759 Netherlands   Start Trial PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 15C0062 France   Start Trial PRODUCT NAME: TEDIZOLIDE,EVENTUELLEMENT SOUS LA FORME D'UN ESTER ,EN PARTICULIER UN PHOSPHATE,OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/991 20150325
1699784 52/2015 Austria   Start Trial PRODUCT NAME: TEDIZOLID, WAHLWEISE IN DER FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 C20150036 00229 Estonia   Start Trial PRODUCT NAME: TEDISOLIIDFOSFAAT;REG NO/DATE: EU/1/15/991 25.03.2015
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Harvard Business School
Moodys
Express Scripts
Boehringer Ingelheim

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