Ofloxacin - Generic Drug Details

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What are the generic 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, Sandoz, Sentiss, Somerset, Daiichi, Hikma, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ofloxacin

US Patents:	0
Tradenames:	6
Applicants:	23
NDAs:	32
Drug Master File Entries:	78
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	37
Patent Applications:	6,459
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
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	300MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

US Patents and Regulatory Information for ofloxacin

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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
Epic Pharma Llc	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	076615-001	May 14, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	215886-001	Nov 23, 2022	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	OFLOXACIN	ofloxacin	TABLET;ORAL	077098-001	Feb 10, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OTIC	211525-001	Aug 30, 2019	AT	RX	No	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 ofloxacin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Daiichi	FLOXIN OTIC	ofloxacin	SOLUTION/DROPS;OTIC	020799-001	Dec 16, 1997	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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