ZYVOX Drug Patent Profile
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When do Zyvox patents expire, and what generic alternatives are available?
Zyvox is a drug marketed by Pfizer and is included in three NDAs.
The generic ingredient in ZYVOX is linezolid. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zyvox
A generic version of ZYVOX was approved as linezolid by HIKMA on June 3rd, 2015.
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Summary for ZYVOX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Patent Applications: | 4,240 |
| Drug Prices: | Drug price information for ZYVOX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZYVOX |
| What excipients (inactive ingredients) are in ZYVOX? | ZYVOX excipients list |
| DailyMed Link: | ZYVOX at DailyMed |
Pharmacology for ZYVOX
| Drug Class | Oxazolidinone Antibacterial |
Paragraph IV (Patent) Challenges for ZYVOX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZYVOX | Injection | linezolid | 2 mg/mL, 100 mL bag | 021131 | 1 | 2009-12-29 |
| ZYVOX | Injection | linezolid | 2 mg/mL, 300 mL bag | 021131 | 1 | 2009-09-01 |
| ZYVOX | Oral Suspension | linezolid | 100 mg/5 mL | 021132 | 1 | 2009-08-03 |
| ZYVOX | Tablets | linezolid | 600 mg | 021130 | 1 | 2005-12-21 |
US Patents and Regulatory Information for ZYVOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ZYVOX | linezolid | FOR SUSPENSION;ORAL | 021132-001 | Apr 18, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-003 | Apr 18, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-001 | Apr 18, 2000 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-002 | Apr 18, 2000 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for ZYVOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-002 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZYVOX | linezolid | FOR SUSPENSION;ORAL | 021132-001 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-001 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-002 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZYVOX
See the table below for patents covering ZYVOX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1208058 | ⤷ Sign Up | |
| Denmark | 1265608 | ⤷ Sign Up | |
| Argentina | 033357 | UNA TABLETA COMPRIMIDA QUE CONTIENE OXAZOLIDINONA Y EL USO DE DICHA TABLETA PARA LA MANUFACTURA DE UN MEDICAMENTO | ⤷ Sign Up |
| Norway | 20024505 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYVOX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0717738 | PA2004004 | Lithuania | ⤷ Sign Up | PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS |
| 0717738 | PA2004004,C0717738 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINEZOLIDUM ((S)-N-((3-(3-FLUOR-4-(4-MORFOLINIL)FENIL)-2-OKSO--5-OKSAZOLIDINIL)METIL)-ACETAMIDAS); REGISTRATION NO/DATE: 02/8199/2 20030313 |
| 0717738 | C00717738/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| 0717738 | SPC001/2002 | Ireland | ⤷ Sign Up | SPC001/2002: 20031204, EXPIRES: 20160104 |
| >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.
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