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Generated: June 26, 2017

DrugPatentWatch Database Preview

ZYVOX Drug Profile

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What is the patent landscape for Zyvox, and what generic Zyvox alternatives are available?

Zyvox is a drug marketed by Pharmacia And Upjohn and is included in three NDAs. There are two patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in thirty-six countries.

The generic ingredient in ZYVOX is linezolid. There are twenty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the linezolid profile page.

Summary for Tradename: ZYVOX

Patents:2
Applicants:1
NDAs:3
Suppliers / Packagers: see list8
Bulk Api Vendors: see list70
Clinical Trials: see list10
Patent Applications: see list3,337
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZYVOX at DailyMed

Pharmacology for Tradename: ZYVOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 2000DISCNYesNo6,514,529*PED► SubscribeY► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
SOLUTION;IV (INFUSION)021131-003Apr 18, 2000APRXYesYes6,559,305*PED► SubscribeY► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 2000ABRXYesYes6,559,305*PED► SubscribeY► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
FOR SUSPENSION;ORAL021132-001Apr 18, 2000ABRXYesYes6,559,305*PED► SubscribeY► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 2000DISCNYesNo6,559,305*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: ZYVOX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
FOR SUSPENSION;ORAL021132-001Apr 18, 20005,688,792*PED► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 20005,688,792*PED► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 20005,688,792*PED► Subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
SOLUTION;IV (INFUSION)021131-001Apr 18, 20005,688,792*PED► Subscribe
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Paragraph IV activity for: ZYVOX

Drugname Dosage Strength RLD Submissiondate
linezolidInjection2 mg/mL, 100 mL bagZyvox12/29/2009
linezolidInjection2 mg/mL, 300 mL bagZyvox9/1/2009
linezolidOral Suspension100 mg/5 mLZyvox8/3/2009
linezolidTablets600 mgZyvox12/21/2005

Non-Orange Book Patents for Tradename: ZYVOX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,444,813 Linezolid-crystal form II► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZYVOX

Country Document Number Estimated Expiration
Colombia5261555► Subscribe
World Intellectual Property Organization (WIPO)0170225► Subscribe
Norway20065836► Subscribe
Slovakia12092002► Subscribe
Czech Republic302292► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZYVOX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004004,C0717738Lithuania► SubscribePRODUCT NAME: LINEZOLIDUM ((S)-N-((3-(3-FLUOR-4-(4-MORFOLINIL)FENIL)-2-OKSO--5-OKSAZOLIDINIL)METIL)-ACETAMIDAS); REGISTRATION NO/DATE: 02/8199/2 20030313
2004004Lithuania► SubscribePRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
C0005France► SubscribePRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
C/GB01/025United Kingdom► SubscribePRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
/2002Austria► SubscribePRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Healthtrust
Johnson and Johnson
Fish and Richardson
Deloitte
Fuji
Merck
US Department of Justice
Argus Health
Cerilliant

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 verifification 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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