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Last Updated: January 30, 2023

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-seven patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for tedizolid phosphate
International Patents:77
US Patents:7
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 14
Patent Applications: 223
What excipients (inactive ingredients) are in tedizolid phosphate?tedizolid phosphate excipients list
DailyMed Link:tedizolid phosphate at DailyMed
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 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 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 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 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 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 POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

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
Spain 2734724 See Plans and Pricing
Australia 2009200606 Novel oxazolidinone derivatives See Plans and Pricing
South Korea 20050061271 NOVEL OXAZOLIDINONE DERIVATIVES, A PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME FOR ANTIBIOTICS 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
Cuba 24089 FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA See Plans and Pricing
New Zealand 620458 Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate See Plans and Pricing
Australia 2004299413 Novel oxazolidinone derivatives See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tedizolid phosphate

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 2015/048 Ireland See Plans and Pricing PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 92834 Luxembourg See Plans and Pricing 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 52/2015 Austria See Plans and Pricing 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 C01699784/01 Switzerland See Plans and Pricing PRODUCT NAME: TEDIZOLID; REGISTRATION NO/DATE: SWISSMEDIC 65270 05.01.2016
1699784 C300759 Netherlands See Plans and Pricing PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784 300762 Netherlands See Plans and Pricing PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE VORM VAN EEN ESTER, IN HET BIJZONDER EEN FOSFAAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/991 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
AstraZeneca
Moodys
McKesson
Baxter

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