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Last Updated: May 26, 2022

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-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.

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:77
US Patents:7
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 4
Patent Applications: 692
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 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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterPhase 2
Hartford HospitalPhase 1

See all SIVEXTRO clinical trials

US Patents and Regulatory Information for SIVEXTRO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIVEXTRO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oxazolidinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSSI) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA

Oxazolidinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SIVEXTRO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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: See Plans and Pricing

Australia

Patent: 10210627
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1008829
Estimated Expiration: See Plans and Pricing

Canada

Patent: 51392
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11001855
Estimated Expiration: See Plans and Pricing

China

Patent: 2439006
Estimated Expiration: See Plans and Pricing

Patent: 7082790
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 20071
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110464
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 089
Estimated Expiration: See Plans and Pricing

Patent: 110155
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 011000251
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 11011285
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 93808
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4401
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84705
Estimated Expiration: See Plans and Pricing

Patent: 12516894
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6354
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11008093
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 092
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4408
Estimated Expiration: See Plans and Pricing

Patent: 0458
Estimated Expiration: See Plans and Pricing

Patent: 2289
Estimated Expiration: See Plans and Pricing

Peru

Patent: 120585
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014500092
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 55928
Estimated Expiration: See Plans and Pricing

Patent: 11136537
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3497
Estimated Expiration: See Plans and Pricing

Patent: 201500207Q
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1106412
Estimated Expiration: See Plans and Pricing

Patent: 1306536
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1739923
Estimated Expiration: See Plans and Pricing

Patent: 1918678
Estimated Expiration: See Plans and Pricing

Patent: 110120311
Estimated Expiration: See Plans and Pricing

Patent: 170040371
Estimated Expiration: See Plans and Pricing

Patent: 170135984
Estimated Expiration: See Plans and Pricing

Spain

Patent: 34724
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000381
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4068
Estimated Expiration: See Plans and Pricing

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
South Korea 20170135984 R)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate) See Plans and Pricing
Spain 2734724 See Plans and Pricing
South Korea 20170040371 R)-3--5-히드록시메틸 옥사졸리딘-2-온 디히드로겐 포스페이트의 결정형 (-3-4-2-2--5--5--3--5- -2- Crystalline form of R-3-4-2-2-methyltetrazol-5-ylpyridin-5-yl-3-fluorophenyl-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate) See Plans and Pricing
Brazil PI1008829 forma cristalina de dihidrogenofosfato de (r)-3-(4-(2-(2-metiltetrazol-5-il) piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona See Plans and Pricing
Japan 2012516894 See Plans and Pricing
Russian Federation 2010149618 НОВЫЕ ПРОИЗВОДНЫЕ ОКСАЗОЛИДИНОНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ See Plans and Pricing
China 102516238 Novel oxazolidinone derivatives See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIVEXTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 132016000024232 Italy See Plans and Pricing PRODUCT NAME: TEDIZOLID, FACOLTATIVAMENTE IN FORMA DI ESTERE, IN PARTICOLARE UN FOSFATO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SIVEXTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/991/001, 20150325
1699784 CA 2015 00048 Denmark See Plans and Pricing 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 C 2015 035 Romania See Plans and Pricing 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 C01699784/01 Switzerland See Plans and Pricing PRODUCT NAME: TEDIZOLID; REGISTRATION NO/DATE: SWISSMEDIC 65270 05.01.2016
1699784 1590047-5 Sweden See Plans and Pricing 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 CR 2015 00048 Denmark See Plans and Pricing 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 675 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
AstraZeneca
Moodys
Baxter
McKesson

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.