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Last Updated: December 7, 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 Pharms, Pfizer, Eugia Pharma, 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

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Recent Clinical Trials for LINEZOLID

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SponsorPhase
University of California, San FranciscoPhase 2
Novartis PharmaceuticalsPhase 2
Harvard Medical SchoolPhase 2

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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
Hetero Labs Ltd V LINEZOLID linezolid TABLET;ORAL 204239-001 Dec 21, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Sagent Pharms Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 204696-001 Mar 2, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd LINEZOLID linezolid SOLUTION;INTRAVENOUS 205154-002 Dec 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nang Kuang Pharm Co LINEZOLID linezolid SOLUTION;INTRAVENOUS 207354-001 Dec 20, 2016 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hq Spclt Pharma LINEZOLID linezolid SOLUTION;INTRAVENOUS 207001-002 Jul 7, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma Pharms LINEZOLID linezolid FOR SUSPENSION;ORAL 200068-001 Jun 3, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-002 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-001 Apr 18, 2000 ⤷  Try it Free ⤷  Try it Free
>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 PA2004004 Lithuania ⤷  Try it Free PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
0717738 12/2002 Austria ⤷  Try it Free 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 it Free 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 SPC/GB01/025 United Kingdom ⤷  Try it Free 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 ⤷  Try it Free 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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