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 Hetero Labs, Hikma, 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-four NDAs.
The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-four 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 HIKMA on June 3rd, 2015.
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Questions you can ask:
- What is the 5 year forecast for LINEZOLID?
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- What is Average Wholesale Price for LINEZOLID?
Summary for LINEZOLID
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 24 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 146 |
| Patent Applications: | 4,961 |
| Drug Prices: | Drug price information 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 |
|---|---|
| European Respiratory Society | Phase 2 |
| Radboud University Medical Center | Phase 2 |
| University of Milano | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | LINEZOLID | linezolid | TABLET;ORAL | 206097-001 | Feb 22, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | linezolid | SOLUTION;INTRAVENOUS | 206473-001 | Jun 18, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs | LINEZOLID | linezolid | FOR SUSPENSION;ORAL | 211813-001 | Oct 31, 2022 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
