Ofloxacin - Generic Drug Details

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, Somerset Theraps Llc, Janssen Pharms, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in thirty-three 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:	24
NDAs:	33
Drug Master File Entries:	78
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	37
Patent Applications:	6,240
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
Fdc Ltd	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	078559-001	Feb 25, 2009	AT	RX	No	No
Epic Pharma Llc	OFLOXACIN	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	076615-001	May 14, 2004		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992		DISCN	No	No
Daiichi	FLOXIN OTIC	ofloxacin	SOLUTION/DROPS;OTIC	020799-001	Dec 16, 1997		DISCN	Yes	No

Expired US Patents for ofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992

Ofloxacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ofloxacin

Introduction to Ofloxacin

Ofloxacin is a fluoroquinolone antibiotic used to treat various bacterial infections, including those of the skin, respiratory tract, and urinary system. Its broad-spectrum activity and favorable pharmacokinetic profile make it a valuable asset in the pharmaceutical industry.

Market Growth Drivers

Increasing Prevalence of Infectious Diseases

The global ofloxacin market is driven by the rising prevalence of infectious diseases such as bronchitis, pneumonia, and infections of the skin, reproductive organs, bladder, urinary tract, and prostate. The emergence of mutant bacterial strains and the increasing incidence of multi-drug resistant bacteria are significant factors fueling market growth[1][5].

Advantages Over Other Antibiotics

Ofloxacin's benefits, including good oral absorption, easy tissue penetration, and a convenient once or twice daily dosage, make it a preferred choice over other antibacterial drugs. These properties are anticipated to accelerate the growth of the ofloxacin market[1].

Cost-Effectiveness

Studies have shown that sequential intravenous-to-oral ofloxacin therapy is as effective and consistently less expensive than standard switch antibiotics. This cost-effectiveness is a crucial driver, especially in healthcare systems looking to optimize resource utilization[2].

Market Segmentation

By Type

The global ofloxacin market is segmented into oral, intravenous therapy (IV), and topical (eye drops and ear drops) forms. The oral segment is expected to hold the largest share due to its high bioavailability and convenience[1].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to hold the largest share, as ofloxacin is a prescription drug that often requires physician consultation before administration[1].

By Geography

The market is classified into North America, Europe, Asia Pacific, and the rest of the world. North America is expected to hold the largest market share, while the Asia Pacific region is anticipated to grow at the highest CAGR due to the large population base and increasing prevalence of infectious diseases[1].

Financial Trajectory

Market Size and Forecast

The ofloxacin market is growing at a significant pace and is expected to gain substantial shares in the forecasted period from 2020 to 2027. The market size is projected to increase due to the rising demand for effective antibacterial treatments[1].

Revenue Growth

The revenue growth of the global ofloxacin market is driven by factors such as increasing healthcare spending, advancements in the healthcare sector, and the adoption of latest tools and techniques. The market is expected to register rapid growth, particularly in the Asia Pacific region[4].

Cost Savings and Economic Impact

Sequential ofloxacin therapy has been shown to result in cost savings compared to standard switch therapy. An average cost savings of $399 per patient was observed in one study, highlighting the economic benefits of using ofloxacin[2].

Challenges and Restraints

Side Effects and Risks

Despite its benefits, ofloxacin is associated with risks such as tendon rupture, especially in older patients and those taking corticosteroids. It can also cause muscle weakness in patients with myasthenia gravis, which may hamper market growth[1].

Regulatory and Compliance Issues

The use of ofloxacin is regulated, and it falls under the category of prescription drugs. This can create compliance issues and may affect market dynamics, particularly in regions with strict regulatory frameworks[1].

Competitive Landscape

Key Players

The global ofloxacin market includes major players such as Novartis, Teva, Allergan, Apotex, Janssen, Daiichi Sankyo, Cadila Pharmaceuticals, Bestochem, Almatica Pharma, and Meda Pharmaceuticals Inc. These companies are adopting various strategies like R&D investments, partnerships, and mergers to maintain their market position[1][4].

Opportunities and Future Outlook

Increasing Awareness and New Infectious Diseases

Growing awareness among people and the increasing prevalence of new infectious diseases with bacterial resistance are expected to generate significant opportunities for the ofloxacin market[1].

Technological Advancements and Healthcare Improvements

Advancements in healthcare technology and improving healthcare facilities are expected to drive the adoption of ofloxacin and other advanced antibacterial treatments. The ongoing pandemic has also highlighted the need for effective and cost-efficient treatments, which could further boost the market[4].

Ofloxacin Eye Drops Market

Market Growth and Segmentation

The global ofloxacin eye drops market is anticipated to grow at a considerable CAGR, driven by the increasing prevalence of chronic diseases and the emergence of mutant bacterial strains. The market is segmented by application (ophthalmic surgery and anti-inflammatory) and end-user (adults and children)[5].

Regional Analysis

The ofloxacin eye drops market covers major regions including North America, Europe, Asia Pacific, and the rest of the world. Companies like Novartis AG, Allergan, Inc., and Meda Pharmaceuticals Inc. are key players in this segment[5].

Key Takeaways

• The ofloxacin market is driven by the increasing prevalence of infectious diseases and the emergence of multi-drug resistant bacteria.
• The oral segment of ofloxacin holds the largest market share due to its high bioavailability.
• North America is expected to hold the largest market share, while the Asia Pacific region is anticipated to grow at the highest CAGR.
• The market faces challenges such as side effects and regulatory issues but is expected to benefit from growing awareness and technological advancements.
• The ofloxacin eye drops market is also growing significantly, driven by the increasing prevalence of chronic diseases.

FAQs

1. What are the primary drivers of the ofloxacin market?

The primary drivers include the increasing prevalence of infectious diseases, the emergence of mutant bacterial strains, and the cost-effectiveness of ofloxacin compared to other antibiotics.

2. Which segment holds the largest share in the ofloxacin market?

The oral segment holds the largest share due to its high bioavailability and convenience.

3. What are the major side effects associated with ofloxacin?

Major side effects include tendon rupture, especially in older patients and those taking corticosteroids, and muscle weakness in patients with myasthenia gravis.

4. Who are the key players in the ofloxacin market?

Key players include Novartis, Teva, Allergan, Apotex, Janssen, Daiichi Sankyo, Cadila Pharmaceuticals, Bestochem, Almatica Pharma, and Meda Pharmaceuticals Inc.

5. What is the outlook for the ofloxacin eye drops market?

The ofloxacin eye drops market is anticipated to grow significantly, driven by the increasing prevalence of chronic diseases and the emergence of mutant bacterial strains.

Cited Sources:

1. Verified Market Research: Ofloxacin Market Size | Share | Industry Analysis | Trends | Forecast
2. PubMed: Cost-effectiveness comparison of sequential ofloxacin versus standard switch antibiotics
3. Market Research Intellect: Global Ofloxacin Eye Drops Sales Market Size, Scope And Forecast Report
4. BioSpace: Ofloxacin Eye Drop Market Growth 2022-2028 - BioSpace
5. Business Wire: Insights on the Ofloxacin Eye Drops Global Market to 2027 - ResearchAndMarkets.com