LEVOFLOXACIN - Generic Drug Details

What are the generic drug sources for levofloxacin and what is the scope of patent protection?

Levofloxacin is the generic ingredient in six branded drugs marketed by Janssen Pharms, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Mylan Asi, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Akorn, Micro Labs Ltd India, Mylan Labs Ltd, Rubicon, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, and Zydus Lifesciences, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-one drug master file entries for levofloxacin. Forty-four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for LEVOFLOXACIN

US Patents:	0
Tradenames:	6
Applicants:	39
NDAs:	48
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	275
Patent Applications:	7,712
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

See drug prices for LEVOFLOXACIN

See drug sales revenues for LEVOFLOXACIN

Recent Clinical Trials for LEVOFLOXACIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yi Yang	N/A
Melva Louisa	Phase 1
Tanta University	N/A

See all LEVOFLOXACIN clinical trials

Generic filers with tentative approvals for LEVOFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		5MG/ML	INJECTABLE; INJECTION
		750MG	TABLET; ORAL
		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

Anti-Bacterial Agents

Anti-Infective Agents, Urinary

Cytochrome P-450 CYP1A2 Inhibitors

Topoisomerase II Inhibitors

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 Teva	LEVOFLOXACIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	076826-001	Feb 10, 2011		DISCN	No	No
Watson Labs Inc	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	201484-001	Nov 22, 2013		DISCN	No	No
Jubilant Generics	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	203613-002	Jun 19, 2015		DISCN	No	No
Gland Pharma Ltd	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206908-002	Dec 30, 2020	AP	RX	No	No
Eugia Pharma	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206919-003	Feb 10, 2016		DISCN	No	No
Hospira	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	078577-001	Aug 12, 2015		DISCN	No	No
Avet Lifesciences	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	202590-002	Jan 24, 2013		DISCN	No	No

Expired US Patents for LEVOFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	IQUIX	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021571-001	Mar 1, 2004
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-004	Dec 20, 1996
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-003	Sep 8, 2000

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