LEVOFLOXACIN Drug Patent Profile
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Which patents cover Levofloxacin, and when can generic versions of Levofloxacin launch?
Levofloxacin is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, 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, Zydus Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, and Knack. and is included in forty-three NDAs.
The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-eight 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 RISING on December 20th, 2010.
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Questions you can ask:
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Summary for LEVOFLOXACIN
| US Patents: | 0 |
| Applicants: | 36 |
| NDAs: | 43 |
| Finished Product Suppliers / Packagers: | 42 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 282 |
| Patent Applications: | 5,337 |
| 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 |
|---|---|
| National Medical Center for Infectious Diseases | Phase 3 |
| Beijing Chest Hospital | Phase 3 |
| Isala | Phase 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Inc | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 201484-002 | Nov 22, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glenmark Pharms Ltd | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 200250-003 | Jun 20, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 201043-003 | Jun 20, 2011 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 206908-001 | Dec 30, 2020 | AP | 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 |
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 |
