Levofloxacin - Generic Drug Details
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What are the generic drug sources for levofloxacin and what is the scope of freedom to operate?
Levofloxacin
is the generic ingredient in six branded drugs marketed by Janssen Pharms, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, and Zydus Lifesciences, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-one drug master file entries for levofloxacin. Forty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for levofloxacin
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 38 |
| NDAs: | 48 |
| Drug Master File Entries: | 31 |
| Finished Product Suppliers / Packagers: | 48 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 282 |
| Patent Applications: | 7,712 |
| Drug Prices: | Drug price trends for levofloxacin |
| Drug Sales Revenues: | Drug sales revenues for levofloxacin |
| What excipients (inactive ingredients) are in levofloxacin? | levofloxacin excipients list |
| DailyMed Link: | levofloxacin at DailyMed |
Recent Clinical Trials for levofloxacin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Medical Center for Infectious Diseases | Phase 3 |
| Beijing Chest Hospital | Phase 3 |
| Spaarne Gasthuis | Phase 4 |
Generic filers with tentative approvals for LEVOFLOXACIN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for levofloxacin
Anatomical Therapeutic Chemical (ATC) Classes for levofloxacin
Paragraph IV (Patent) Challenges for LEVOFLOXACIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LEVAQUIN | Oral Solution | levofloxacin | 25 mg/mL | 021721 | 1 | 2009-07-30 |
US Patents and Regulatory Information for levofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Lifesciences | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077652-003 | Sep 7, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 078579-002 | Sep 3, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Molecular | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 076890-003 | Mar 30, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | LEVAQUIN | levofloxacin | TABLET;ORAL | 020634-003 | Sep 8, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd V | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 202801-002 | Jan 8, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | LEVOFLOXACIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 077700-001 | Dec 20, 2010 | RX | No | Yes | ⤷ 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 levofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | LEVAQUIN | levofloxacin | TABLET;ORAL | 020634-002 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-005 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | LEVAQUIN | levofloxacin | TABLET;ORAL | 020634-003 | Sep 8, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for levofloxacin
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Chiesi Farmaceutici S.p.A | Quinsair | levofloxacin | EMEA/H/C/002789 Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2015-03-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
