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Last Updated: November 2, 2024

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 Hetero Labs, Hikma, Pfizer, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

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
LMU University Hospital MunichPhase 2
University of CambridgePhase 2
University College, LondonPhase 2

See all LINEZOLID clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Pharms Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 204696-001 Mar 2, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz LINEZOLID linezolid SOLUTION;INTRAVENOUS 200904-001 Jul 16, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms LINEZOLID linezolid TABLET;ORAL 206097-001 Feb 22, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic LINEZOLID linezolid TABLET;ORAL 205233-001 Dec 21, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hq Spclt Pharma LINEZOLID linezolid SOLUTION;INTRAVENOUS 207001-002 Jul 7, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx LINEZOLID linezolid TABLET;ORAL 210702-001 Apr 25, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V LINEZOLID linezolid TABLET;ORAL 204239-001 Dec 21, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 021131-001 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid TABLET;ORAL 021130-001 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.