LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile
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Which patents cover Levofloxacin In Dextrose 5% In Plastic Container, and when can generic versions of Levofloxacin In Dextrose 5% In Plastic Container launch?
Levofloxacin In Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Inforlife, and Knack. and is included in eight NDAs.
The generic ingredient in LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER 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 In Dextrose 5% In Plastic Container
A generic version of LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as levofloxacin by RISING on December 20th, 2010.
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Summary for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
US Patents: | 0 |
Applicants: | 8 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 9 |
Clinical Trials: | 282 |
DailyMed Link: | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed |
Recent Clinical Trials for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Medical Center for Infectious Diseases | Phase 3 |
Beijing Chest Hospital | Phase 3 |
Elisabeth-TweeSteden Ziekenhuis | Phase 4 |
See all LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials
US Patents and Regulatory Information for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baxter Hlthcare Corp | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 091397-001 | Aug 8, 2013 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hospira | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 078579-003 | Sep 3, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Knack | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 216164-003 | Jan 29, 2024 | DISCN | 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 IN DEXTROSE 5% IN PLASTIC CONTAINER
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 |