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LEVOFLOXACIN Drug Profile
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Which patents cover Levofloxacin, and when can generic versions of Levofloxacin launch?
Levofloxacin is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Micro Labs Ltd India, Mylan Labs Ltd, Rising, Rubicon, Watson Labs Teva, Lannett Co Inc, Apotex Inc, Celltrion, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife. and is included in forty-two NDAs.
The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levofloxacin
A generic version of LEVOFLOXACIN was approved as levofloxacin by AKORN on December 20th, 2010.
Summary for LEVOFLOXACIN
| US Patents: | 0 |
| Applicants: | 34 |
| NDAs: | 42 |
| Suppliers / Packagers: | 49 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 231 |
| Patent Applications: | 4,302 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVOFLOXACIN |
| Drug Sales Revenues: | Drug sales revenues for LEVOFLOXACIN |
| DailyMed Link: | LEVOFLOXACIN at DailyMed |
See drug prices for LEVOFLOXACIN
Recent Clinical Trials for LEVOFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shaheed Benazir Bhutto University Sheringal Dir Upper | Phase 1 |
| PolyActiva Pty Ltd | Phase 1 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | N/A |
Medical Subject Heading (MeSH) Categories for LEVOFLOXACIN
Paragraph IV (Patent) Challenges for LEVOFLOXACIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVAQUIN | SOLUTION;ORAL | levofloxacin | 021721 | 2009-07-30 |
| LEVAQUIN | INJECTABLE;INJECTION | levofloxacin | 020635 | |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | levofloxacin | 020635 | |
| QUIXIN | SOLUTION/DROPS;OPHTHALMIC | levofloxacin | 021199 | |
| LEVAQUIN | TABLET;ORAL | levofloxacin | 020634 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Inc | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 201484-002 | Nov 22, 2013 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Glenmark Generics | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 200250-003 | Jun 20, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Celltrion | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 090367-003 | Jun 20, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
