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Last Updated: March 29, 2024

ZYVOX Drug Patent Profile


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When do Zyvox patents expire, and when can generic versions of Zyvox launch?

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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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
>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 ⤷  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 TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a 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 CA 2002 00004 Denmark ⤷  Try a Trial
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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