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Last Updated: February 28, 2024

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-five 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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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000 AP RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

Expired US Patents for ZYVOX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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
Eurasian Patent Organization 200200819 ⤷  Try a Trial
European Patent Office 0717738 AGENTS ANTIMICROBIENS OXAZOLIDINONE A SUBSTITUTION OXAZINE ET THIAZINE (SUBSTITUTED OXAZINE AND THIAZINE OXAZOLIDINONE ANTIMICROBIALS) ⤷  Try a Trial
Slovenia 1255754 ⤷  Try a Trial
Ukraine 77654 COMPRESSED TABLET OF LINEZOLIDE ⤷  Try a Trial
Israel 151010 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYVOX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 PA2004004,C0717738 Lithuania ⤷  Try a Trial 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 ⤷  Try a Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0717738 12/2002 Austria ⤷  Try a Trial PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
0717738 02C0005 France ⤷  Try a Trial PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0717738 SPC/GB01/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
>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.