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Last Updated: December 7, 2021

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LINEZOLID Drug Patent Profile

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When do Linezolid patents expire, and what generic alternatives are available?

Linezolid is a drug marketed by Hikma Pharms, 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-two NDAs.

The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Linezolid

A generic version of LINEZOLID was approved as linezolid by TEVA PHARMS on June 27th, 2012.

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Drug patent expirations by year for LINEZOLID
Drug Prices for LINEZOLID

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Recent Clinical Trials for LINEZOLID

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Harvard Medical School (HMS and HSDM)Phase 2
Boston UniversityPhase 2
University of California, San FranciscoPhase 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
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
Amneal Pharms LINEZOLID linezolid TABLET;ORAL 204536-001 Dec 21, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novel Labs Inc LINEZOLID linezolid TABLET;ORAL 207526-001 Aug 22, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd LINEZOLID linezolid SOLUTION;INTRAVENOUS 205154-001 Dec 6, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira Inc LINEZOLID linezolid SOLUTION;INTRAVENOUS 205442-001 Jul 7, 2015 AP 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

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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.