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, Macleods Pharms Ltd, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-two drug master file entries for linezolid. Twenty-five suppliers are listed for this compound.
Summary for LINEZOLID
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 24 |
NDAs: | 28 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 25 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 146 |
Patent Applications: | 5,575 |
Drug Prices: | Drug price trends for LINEZOLID |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINEZOLID |
What excipients (inactive ingredients) are in LINEZOLID? | LINEZOLID excipients list |
DailyMed Link: | LINEZOLID at DailyMed |
Recent Clinical Trials for LINEZOLID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lygature | Phase 2 |
University of Hamburg-Eppendorf | Phase 2 |
German Center for Infection Research | Phase 2 |
Pharmacology for LINEZOLID
Drug Class | Oxazolidinone Antibacterial |
Medical Subject Heading (MeSH) Categories for LINEZOLID
Anatomical Therapeutic Chemical (ATC) Classes 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 | 204696-002 | Mar 2, 2017 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Sagent Pharms Inc | LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 204696-001 | Mar 2, 2017 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Eugia Pharma | LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 206917-001 | Aug 4, 2016 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-002 | Apr 18, 2000 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | ZYVOX | linezolid | SOLUTION;INTRAVENOUS | 021131-002 | Apr 18, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-001 | Apr 18, 2000 | ⤷ Subscribe | ⤷ Subscribe |
Pfizer | ZYVOX | linezolid | FOR SUSPENSION;ORAL | 021132-001 | Apr 18, 2000 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
LINEZOLID Market Analysis and Financial Projection Experimental
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