Levofloxacin - Generic Drug Details

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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 Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, 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, 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-eight 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:	48
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	282
Patent Applications:	7,712
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

Drug Sales Revenue Trends for levofloxacin

See drug sales revenues 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
Onze Lieve Vrouwe Gasthuis	Phase 4

See all levofloxacin clinical trials

Generic filers with tentative approvals for LEVOFLOXACIN

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hec Pharm	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	204968-002	Feb 5, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	078577-002	Aug 12, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	200560-002	Jun 20, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Farmaceutica	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	091375-001	Sep 16, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	078579-002	Sep 3, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare Corp	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	091397-003	Aug 8, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Inforlife	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	090343-002	Jul 7, 2011	AP	RX	No	Yes	⤷ 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 levofloxacin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996	⤷ Sign Up	⤷ Sign Up
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-002	Dec 20, 1996	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-003	Sep 8, 2000	⤷ Sign Up	⤷ Sign Up
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for levofloxacin

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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

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