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Last Updated: March 28, 2024

Tedizolid phosphate - Generic Drug Details


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What are the generic drug sources for tedizolid phosphate and what is the scope of freedom to operate?

Tedizolid phosphate is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tedizolid phosphate has seventy-eight patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for tedizolid phosphate
International Patents:78
US Patents:7
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 58
Clinical Trials: 14
Patent Applications: 181
What excipients (inactive ingredients) are in tedizolid phosphate?tedizolid phosphate excipients list
DailyMed Link:tedizolid phosphate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tedizolid phosphate
Generic Entry Dates for tedizolid phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for tedizolid phosphate*:
Constraining patent/regulatory exclusivity:
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 tedizolid phosphate

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

SponsorPhase
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterPhase 2
Los Angeles Biomedical Research InstitutePhase 2
University of Southern CaliforniaPhase 4

See all tedizolid phosphate clinical trials

Pharmacology for tedizolid phosphate

US Patents and Regulatory Information for tedizolid phosphate

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 ⤷  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 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 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 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 ⤷  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 tedizolid phosphate

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 tedizolid phosphate

Country Patent Number Title Estimated Expiration
Australia 2009200606 Novel oxazolidinone derivatives ⤷  Try a Trial
Malaysia 156354 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
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) ⤷  Try a Trial
European Patent Office 2305657 Dérivés d'oxazolidinone (Oxazolidinone derivatives) ⤷  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
Japan 2012516894 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tedizolid phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1699784 675 Finland ⤷  Try a Trial
1699784 300759 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1699784 92834 Luxembourg ⤷  Try a Trial PRODUCT NAME: TEDIZOLIDE, OPTIONNELLEMENT SOUS LA FORME D UN ESTER, EN PARTICULIER UN PHOSPHATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150325
1699784 PA2015032 Lithuania ⤷  Try a Trial PRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 CR 2015 00048 Denmark ⤷  Try a 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 132016000024232 Italy ⤷  Try a Trial 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
>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.