Levofloxacin - Generic Drug Details

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, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland, Hospira, Pharmobedient, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Rubicon Research, Sciegen Pharms, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, 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, 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-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for levofloxacin

US Patents:	0
Tradenames:	6
Applicants:	38
NDAs:	48
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	318
Patent Applications:	5,397
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
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE3
University of Virginia	PHASE3
Gadjah Mada University	PHASE4

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

Anatomical Therapeutic Chemical (ATC) Classes for levofloxacin

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Glenmark Pharms Ltd	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	200250-001	Jun 20, 2011	AB	RX	No	No
Watson Labs Inc	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	201484-002	Nov 22, 2013		DISCN	No	No
Zydus Pharms	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	205968-002	Jun 1, 2017		DISCN	No	No
Sandoz	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	077438-003	Jun 20, 2011		DISCN	No	No
Hikma Farmaceutica	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	091375-002	Sep 16, 2011	AP	RX	No	No
Gland	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206908-001	Dec 30, 2020	AP	RX	No	No
Apotex Inc	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	090787-001	Sep 29, 2011		DISCN	No	No

Expired US Patents for levofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
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	TABLET;ORAL	020634-001	Dec 20, 1996

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/002789Quinsair 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