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Last Updated: July 13, 2020

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ZYVOX Drug Profile


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When do Zyvox patents expire, and what generic 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-nine 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-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.

US ANDA Litigation and Generic Entry Outlook for Zyvox

A generic version of ZYVOX was approved as linezolid by TEVA PHARMS on June 27th, 2012.

  Start Trial

Paragraph IV (Patent) Challenges for ZYVOX
Tradename Dosage Ingredient NDA Submissiondate
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-12-29
ZYVOX SOLUTION;INTRAVENOUS linezolid 021131 2009-09-01
ZYVOX FOR SUSPENSION;ORAL linezolid 021132 2009-08-03
ZYVOX TABLET;ORAL linezolid 021130 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
Pharmacia And Upjohn ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000   Start Trial   Start Trial
Pharmacia And Upjohn ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000   Start Trial   Start Trial
Pharmacia And Upjohn ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYVOX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 SPC001/2002 Ireland   Start Trial SPC001/2002: 20031204, EXPIRES: 20160104
0717738 C00717738/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0717738 02C0005 France   Start Trial PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Dow
Express Scripts
McKesson
Baxter

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