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Last Updated: March 19, 2024

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SIVEXTRO Drug Patent 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-eight patent family members in thirty-nine countries.

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

DrugPatentWatch® 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
International Patents:78
US Patents:7
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 5
Patent Applications: 105
Drug Prices: Drug price information for SIVEXTRO
What excipients (inactive ingredients) are in SIVEXTRO?SIVEXTRO excipients list
DailyMed Link:SIVEXTRO at DailyMed
Drug patent expirations by year for SIVEXTRO
Drug Prices for SIVEXTRO

See drug prices for SIVEXTRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Assistance Publique - Hôpitaux de ParisPhase 2
Los Angeles Biomedical Research InstitutePhase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterPhase 2

See all SIVEXTRO clinical trials

Pharmacology for SIVEXTRO

US Patents and Regulatory Information for SIVEXTRO

SIVEXTRO is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIVEXTRO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SIVEXTRO

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oxazolidinone derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA

Oxazolidinone derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxy- methyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA

Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting SIVEXTRO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for SIVEXTRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Sivextro tedizolid phosphate EMEA/H/C/002846
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.
Authorised no no no 2015-03-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SIVEXTRO

When does loss-of-exclusivity occur for SIVEXTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 87
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 10210627
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 1008829
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 51392
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11001855
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2439006
Estimated Expiration: ⤷  Try a Trial

Patent: 7082790
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 20071
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 110464
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 089
Estimated Expiration: ⤷  Try a Trial

Patent: 110155
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 011000251
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 11011285
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 93808
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4401
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84705
Estimated Expiration: ⤷  Try a Trial

Patent: 12516894
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6354
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11008093
Estimated Expiration: ⤷  Try a Trial

Patent: 20011773
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 092
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4408
Estimated Expiration: ⤷  Try a Trial

Patent: 0458
Estimated Expiration: ⤷  Try a Trial

Patent: 2289
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 120585
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 014500092
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 55928
Estimated Expiration: ⤷  Try a Trial

Patent: 11136537
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3497
Estimated Expiration: ⤷  Try a Trial

Patent: 201500207Q
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1106412
Estimated Expiration: ⤷  Try a Trial

Patent: 1306536
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1739923
Estimated Expiration: ⤷  Try a Trial

Patent: 1918678
Estimated Expiration: ⤷  Try a Trial

Patent: 110120311
Estimated Expiration: ⤷  Try a Trial

Patent: 170040371
Estimated Expiration: ⤷  Try a Trial

Patent: 170135984
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 34724
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 11000381
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4068
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIVEXTRO around the world.

Country Patent Number Title Estimated Expiration
Japan 2007514737 ⤷  Try a Trial
China 102702184 Novel oxazolidinone derivatives ⤷  Try a Trial
Singapore 173497 CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE ⤷  Try a Trial
Mexico 2011008093 FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTET RAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA. (CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-Y L)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE.) ⤷  Try a Trial
Colombia 6620071 Forma cristalina del fosfato de dihidrogeno r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona ⤷  Try a Trial
China 107082790 种噁唑烷酮化合物的晶型 (Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate) ⤷  Try a Trial
Portugal 1699784 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIVEXTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 122015000078 Germany ⤷  Try a 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
1699784 243 50021-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: TEDIZOLIDFOSFAT; REGISTRATION NO/DATE: EU/1/15/991/001 - EU/1/15/991/003 20150325
1699784 15C0062 France ⤷  Try a 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 1590047-5 Sweden ⤷  Try a 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 PA2015032 Lithuania ⤷  Try a Trial PRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 SPC/GB15/056 United Kingdom ⤷  Try a 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 C01699784/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TEDIZOLID; REGISTRATION NO/DATE: SWISSMEDIC 65270 05.01.2016
>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.