LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile
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Which patents cover Levaquin In Dextrose 5% In Plastic Container, and when can generic versions of Levaquin In Dextrose 5% In Plastic Container launch?
Levaquin In Dextrose 5% In Plastic Container is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in LEVAQUIN 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 Levaquin In Dextrose 5% In Plastic Container
A generic version of LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as levofloxacin by RISING on December 20th, 2010.
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Summary for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 24 |
DailyMed Link: | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed |
Recent Clinical Trials for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Indonesia University | Phase 1/Phase 2 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
Westat | Phase 2 |
See all LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials
US Patents and Regulatory Information for LEVAQUIN 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-003 | Dec 20, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-005 | Dec 20, 1996 | DISCN | Yes | 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 LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
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 |
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-005 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-003 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LEVAQUIN 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 |
International Patents for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
See the table below for patents covering LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Yugoslavia | 42422 | ⤷ Sign Up | |
Ireland | 861631 | ⤷ Sign Up | |
Spain | 556292 | ⤷ Sign Up | |
India | 155680 | A PROCESS FOR PREPARING A 9-HALO-7-OXO-2,3-DIHYDRO-7H-PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE-6-CARBOXYLIC ACID COMPOUND | ⤷ Sign Up |
Austria | 85057 | ⤷ Sign Up | |
Norway | 169896 | ⤷ Sign Up | |
Yugoslavia | 44918 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0206283 | SPC/GB97/085 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606 |
0206283 | 98C0041 | Belgium | ⤷ Sign Up | PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606 |
0206283 | C980016 | Netherlands | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |