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Last Updated: January 25, 2021

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Linezolid - Generic Drug Details

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What are the generic drug sources for linezolid and what is the scope of patent protection?

Linezolid is the generic ingredient in three branded drugs marketed by Hikma, Pfizer, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira Inc, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz Inc, Teva Pharms, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Celltrion, Gate Pharms, Glenmark Pharms, Hetero Labs Ltd V, Mylan, Novel Labs Inc, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-five NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Linezolid has seventy-nine patent family members in thirty-six countries.

There are twenty-two drug master file entries for linezolid. Twenty-five suppliers are listed for this compound.

Drug Prices for linezolid

See drug prices for linezolid

Recent Clinical Trials for linezolid

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
European UnionPhase 3
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 3
European and Developing Countries Clinical Trials Partnership (EDCTP)Phase 3

See all linezolid clinical trials

Pharmacology for linezolid
Medical Subject Heading (MeSH) Categories for linezolid
Paragraph IV (Patent) Challenges for LINEZOLID
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 linezolid

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 TABLET;ORAL 021130-002 Apr 18, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 205442-001 Jul 7, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Nang Kuang Pharm Co LINEZOLID linezolid SOLUTION;INTRAVENOUS 207354-002 Dec 20, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Hikma LINEZOLID linezolid FOR SUSPENSION;ORAL 200068-001 Jun 3, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd LINEZOLID linezolid TABLET;ORAL 205517-001 Dec 21, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer 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 linezolid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000   Start Trial   Start Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000   Start Trial   Start Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000   Start Trial   Start Trial
Pfizer 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 linezolid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 12/2002 Austria   Start 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 Lithuania   Start Trial PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
0717738 SPC/GB01/025 United Kingdom   Start 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
0717738 02C0005 France   Start Trial PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0717738 PA2004004,C0717738 Lithuania   Start 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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