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Last Updated: October 18, 2021

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LINEZOLID - Generic Drug Details

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

Linezolid is the generic ingredient in three branded drugs marketed by Hikma Pharms, 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-four 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
BJ Medical College, AhmedabadPhase 3
SN Medical College, AgraPhase 3
KGMU, LucknowPhase 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
Nang Kuang Pharm Co LINEZOLID linezolid SOLUTION;INTRAVENOUS 207354-001 Dec 20, 2016 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Labs Ltd LINEZOLID linezolid SOLUTION;INTRAVENOUS 205154-001 Dec 6, 2017 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sandoz Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 200904-002 Jul 16, 2015 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira Inc LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER linezolid SOLUTION;INTRAVENOUS 206473-001 Jun 18, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glenmark Pharms LINEZOLID linezolid TABLET;ORAL 078987-001 Dec 21, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LINEZOLID

Country Patent Number Estimated Expiration
Taiwan I293028 ⤷  Free Forever Trial
Eurasian Patent Organization 004434 ⤷  Free Forever Trial
Czech Republic 20023133 ⤷  Free Forever Trial
China 1208058 ⤷  Free Forever Trial
South Africa 200205162 ⤷  Free Forever Trial
South Korea 100864745 ⤷  Free Forever Trial
Hong Kong 1051196 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for LINEZOLID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717738 SPC/GB01/025 United Kingdom ⤷  Free Forever 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 PA2004004,C0717738 Lithuania ⤷  Free Forever 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 02C0005 France ⤷  Free Forever Trial PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0717738 PA2004004 Lithuania ⤷  Free Forever Trial PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
0717738 12/2002 Austria ⤷  Free Forever Trial PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Dow
Johnson and Johnson
AstraZeneca
Harvard Business School

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