TEDIZOLID PHOSPHATE - Generic Drug Details

What are the generic sources for tedizolid phosphate and what is the scope of patent protection?

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

Dosage:

POWDER;INTRAVENOUS

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

Sponsor	Phase
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2
Los Angeles Biomedical Research Institute	Phase 2
University of Southern California	Phase 4

See all TEDIZOLID PHOSPHATE clinical trials

Pharmacology for TEDIZOLID PHOSPHATE

Drug Class	Oxazolidinone Antibacterial
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TEDIZOLID PHOSPHATE

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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			Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes

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

International Patents for TEDIZOLID PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20110464	FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5- HIDROXIMETIL OXAZOLIDIN-2-ONA
Hong Kong	1153738	OXAZOLIDINONE DERIVATIVES AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME
Russian Federation	2655928	Кристаллические частицы для приготовления твердых лекарственных форм для лечения бактериальных инфекций, реакционная смесь, содержащая такие частицы, и фармацевтическая композиция для лечения бактериальных инфекций (CRYSTALLINE PARTICLES FOR PREPARATION OF SOLID DOSAGE FORMS FOR TREATMENT OF BACTERIAL INFECTIONS, REACTION MIXTURE CONTAINING SUCH PARTICLES, AND PHARMACEUTICAL COMPOSITION FOR TREATING BACTERIAL INFECTIONS)

Supplementary Protection Certificates for TEDIZOLID PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	1590047-5	Sweden		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	C 2015 035	Romania		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	132016000024232	Italy		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