TEDIZOLID PHOSPHATE - Generic Drug Details
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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
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
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 |
Pharmacology for TEDIZOLID PHOSPHATE
Drug Class | Oxazolidinone Antibacterial |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Cubist Pharms Llc | SIVEXTRO | tedizolid phosphate | TABLET;ORAL | 205435-001 | Jun 20, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cubist Pharms Llc | SIVEXTRO | tedizolid phosphate | POWDER;INTRAVENOUS | 205436-001 | Jun 20, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Cubist Pharms Llc | SIVEXTRO | tedizolid phosphate | POWDER;INTRAVENOUS | 205436-001 | Jun 20, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|
Morocco | 33092 | FORME CRISTALLINE DU DIHYDROGÉNOPHOSPHATE DE (R)-3-(4-(2-(2-MÉTHYLTÉTRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHÉNYL)-5-HYDROXYMÉTHYL OXAZOLIDIN-2-ONE | ⤷ Sign Up |
Japan | 2012516894 | ⤷ Sign Up | |
Chile | 2011001855 | Partículas cristalinas que comprenden al compuesto fosfato de dihidrógeno de (r)-3-(4-(2-(2-metiltetrazol-5-il)piridin-5-il)-3-fluorofenil)-5-hidroximetil oxazolidin-2-ona; proceso de preparación; mezcla que la comprende; composición farmacéutica; y su uso para tratar una infección bacteriana. | ⤷ Sign Up |
Hong Kong | 1155747 | OXAZOLIDINONE DERIVATIVES | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
1699784 | 300762 | Netherlands | ⤷ Sign Up | 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 |
1699784 | C 2015 035 | Romania | ⤷ Sign Up | 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 | 92834 | Luxembourg | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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