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
| 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 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 | 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 | TABLET;ORAL | 205435-001 | 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 | Y | ⤷ 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 |
|---|---|---|---|
| South Africa | 201306536 | 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 | 101739923 | ⤷ Try a Trial | |
| Spain | 2734724 | ⤷ Try a Trial | |
| Cuba | 24089 | FORMA CRISTALINA DEL FOSFATO DE DIHIDRÓGENO R)-3-(4-(2-(2-METILTRETAZOL-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA | ⤷ Try a Trial |
| Denmark | 1699784 | ⤷ Try a Trial | |
| Austria | 514686 | ⤷ Try a Trial | |
| 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) | ⤷ 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 | 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 |
| 1699784 | 2015/048 | Ireland | ⤷ Try a Trial | 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 | 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 | CA 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 | 122015000078 | Germany | ⤷ Try a Trial | PRODUCT NAME: TEDIZOLID, GEGEBENENFALLS IN FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/991/001-003 20150323 |
| 1699784 | 300759 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| 1699784 | C20150036 00229 | Estonia | ⤷ Try a Trial | PRODUCT NAME: TEDISOLIIDFOSFAAT;REG NO/DATE: EU/1/15/991 25.03.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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DrugPatentWatch Alternatives
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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