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Last Updated: March 29, 2024

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 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 Pharms, 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
Assistance Publique Hopitaux De MarseillePhase 4
The University of Texas Health Science Center, HoustonEarly Phase 1
University of Southern CaliforniaEarly Phase 1

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms LINEZOLID linezolid TABLET;ORAL 206097-001 Feb 22, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER linezolid SOLUTION;INTRAVENOUS 206473-001 Jun 18, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gate Pharms LINEZOLID linezolid TABLET;ORAL 091210-001 Feb 5, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid FOR SUSPENSION;ORAL 021132-001 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid TABLET;ORAL 021130-002 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Pfizer ZYVOX linezolid SOLUTION;INTRAVENOUS 021131-003 Apr 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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