OFLOXACIN - Generic Drug Details

What are the generic drug sources for ofloxacin and what is the scope of freedom to operate?

Ofloxacin is the generic ingredient in six branded drugs marketed by Ortho Mcneil Pharm, Bedford, Allergan, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Micro Labs, Sandoz, Sentiss, Somerset, Daiichi, Bausch And Lomb Inc, Hikma, Somerset Theraps Llc, Janssen Pharms, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-eight drug master file entries for ofloxacin. Thirty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for OFLOXACIN

US Patents:	0
Tradenames:	6
Applicants:	26
NDAs:	34
Drug Master File Entries:	78
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	37
Patent Applications:	7,399
Drug Prices:	Drug price trends for OFLOXACIN
Drug Sales Revenues:	Drug sales revenues for OFLOXACIN
What excipients (inactive ingredients) are in OFLOXACIN?	OFLOXACIN excipients list
DailyMed Link:	OFLOXACIN at DailyMed

See drug prices for OFLOXACIN

See drug sales revenues for OFLOXACIN

Recent Clinical Trials for OFLOXACIN

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

Sponsor	Phase
IVIEW Therapeutics Inc.	Phase 2
Jagiellonian University	N/A
Centre Hospitalier Universitaire, Amiens	N/A

See all OFLOXACIN clinical trials

Generic filers with tentative approvals for OFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		400MG	TABLET;ORAL
		300MG	TABLET;ORAL
		200MG	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.

Pharmacology for OFLOXACIN

Drug Class

Quinolone Antimicrobial

Medical Subject Heading (MeSH) Categories for OFLOXACIN

Anti-Bacterial Agents

Anti-Infective Agents, Urinary

Cytochrome P-450 CYP1A2 Inhibitors

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OFLOXACIN

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

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for OFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	076622-001	May 14, 2004	AT	RX	No	No
Fdc Ltd	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	078559-001	Feb 25, 2009	AT	RX	No	No
Dr Reddys Labs Ltd	OFLOXACIN	ofloxacin	TABLET;ORAL	077098-002	Feb 10, 2006	AB	RX	No	No

Expired US Patents for OFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Daiichi	FLOXIN OTIC	ofloxacin	SOLUTION/DROPS;OTIC	020799-001	Dec 16, 1997	5,401,741
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992	4,382,892