LINEZOLID - Generic Drug Details
✉ Email this page to a colleague
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.
Summary for LINEZOLID
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 23 |
NDAs: | 27 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 146 |
Patent Applications: | 6,600 |
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 |
---|---|
LMU University Hospital Munich | Phase 2 |
University of Cambridge | Phase 2 |
University College, London | 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 | 204696-001 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.