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, Mylan Asi, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Mylan Labs Ltd, Rubicon, Saptalis Pharms, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, 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-seven suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for levofloxacin
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 39 |
| NDAs: | 48 |
| Drug Master File Entries: | 31 |
| Finished Product Suppliers / Packagers: | 47 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 282 |
| Patent Applications: | 7,712 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Beijing Chest Hospital | Phase 3 |
| National Medical Center for Infectious Diseases | Phase 3 |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Inc | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 090787-002 | Sep 29, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077438-003 | Jun 20, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 202328-002 | Jan 24, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glenmark Pharms Ltd | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 200250-002 | Jun 20, 2011 | 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 levofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-003 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Santen | QUIXIN | levofloxacin | SOLUTION/DROPS;OPHTHALMIC | 021199-001 | Aug 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| 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 |
| >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 |
