You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 20, 2024

Ofloxacin - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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

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, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Daiichi, Caplin, Hikma, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ofloxacin

US Patents:	0
Tradenames:	6
Applicants:	22
NDAs:	30
Drug Master File Entries:	78
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	36
Patent Applications:	6,847
Formulation / Manufacturing:	see details
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
Centre Hospitalier Universitaire, Amiens	N/A
University of Patras	Phase 4

See all ofloxacin clinical trials

Generic filers with tentative approvals for OFLOXACIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	400MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	300MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

US Patents and Regulatory Information for ofloxacin

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadila Pharms Ltd	OFLOXACIN	ofloxacin	TABLET;ORAL	091656-002	Sep 18, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fdc Ltd	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OTIC	215038-001	Jan 19, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Larken Labs	OFLOXACIN	ofloxacin	TABLET;ORAL	076093-002	Sep 2, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992	⤷ Try a Trial	⤷ Try a Trial
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992	⤷ Try a Trial	⤷ Try a Trial
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.