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ZYVOX Drug Profile

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

This drug has seventy-two 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-seven 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 list9
Drug Prices: :see details

Pharmacology for Tradename: ZYVOX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 18, 2000DISCNNo6,514,529*PED► subscribeY► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
SOLUTION;IV (INFUSION)021131-003Apr 18, 2000RXYes6,559,305*PED► subscribeY► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-002Apr 18, 2000RXYes6,559,305*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;ORAL021130-002Apr 18, 20005,688,792*PED► subscribe
Pharmacia And Upjohn
ZYVOX
linezolid
TABLET;ORAL021130-001Apr 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
Hungary0300378► subscribe
South Africa200205162► subscribe
Slovakia12092002► 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
2004004Lithuania► subscribePRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
/2002Austria► subscribePRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
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
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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 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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