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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, Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, 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, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Levofloxacin has seven patent family members in seven countries.
There are thirty-one drug master file entries for levofloxacin. Fifty-three suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for levofloxacin
| International Patents: | 7 |
| US Patents: | 1 |
| Tradenames: | 6 |
| Applicants: | 36 |
| NDAs: | 47 |
| Drug Master File Entries: | 31 |
| Suppliers / Packagers: | 53 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 231 |
| Patent Applications: | 37 |
| 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 |
|---|---|
| Shaheed Benazir Bhutto University Sheringal Dir Upper | Phase 1 |
| PolyActiva Pty Ltd | Phase 1 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | N/A |
Generic filers with tentative approvals for LEVOFLOXACIN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 5MG/ML | INJECTABLE; INJECTION |
| Start Trial | Start Trial | 750MG | TABLET; ORAL |
| Start Trial | Start Trial | 500MG | TABLET; ORAL |
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
Paragraph IV (Patent) Challenges for LEVOFLOXACIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVAQUIN | SOLUTION;ORAL | levofloxacin | 021721 | 2009-07-30 |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | levofloxacin | 020635 | |
| QUIXIN | SOLUTION/DROPS;OPHTHALMIC | levofloxacin | 021199 | |
| LEVAQUIN | TABLET;ORAL | levofloxacin | 020634 | |
| LEVAQUIN | INJECTABLE;INJECTION | levofloxacin | 020635 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 076361-001 | Jun 20, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Asi | LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 200560-002 | Jun 20, 2011 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 200674-002 | Jun 19, 2013 | AP | 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 |
Expired US Patents for levofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | LEVAQUIN | levofloxacin | TABLET;ORAL | 020634-002 | Dec 20, 1996 | Start Trial | Start Trial |
| Janssen Pharms | LEVAQUIN | levofloxacin | TABLET;ORAL | 020634-001 | Dec 20, 1996 | Start Trial | Start Trial |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-005 | Dec 20, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for levofloxacin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 129406 | Start Trial |
| European Patent Office | 1372662 | Start Trial |
| Japan | 2004535370 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for levofloxacin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0206283 | 98C0041 | Belgium | Start Trial | PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606 |
| 0206283 | C980016 | Netherlands | Start Trial | PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606 |
| 0206283 | SPC/GB97/085 | United Kingdom | Start Trial | PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
