FLOXIN IN DEXTROSE 5% Drug Patent Profile

Which patents cover Floxin In Dextrose 5%, and what generic alternatives are available?

Floxin In Dextrose 5% is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in FLOXIN IN DEXTROSE 5% is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Floxin In Dextrose 5%

A generic version of FLOXIN IN DEXTROSE 5% was approved as ofloxacin by CHARTWELL RX on September 2^nd, 2003.

Summary for FLOXIN IN DEXTROSE 5%

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	8
DailyMed Link:	FLOXIN IN DEXTROSE 5% at DailyMed

Recent Clinical Trials for FLOXIN IN DEXTROSE 5%

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

Sponsor	Phase
Montefiore Medical Center	Phase 3
Winston Chamberlain, MD, PhD	Phase 4
Stanford University	Phase 4

See all FLOXIN IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for FLOXIN IN DEXTROSE 5%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992		DISCN	No	No

Expired US Patents for FLOXIN IN DEXTROSE 5%

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	4,382,892

International Patents for FLOXIN IN DEXTROSE 5%

See the table below for patents covering FLOXIN IN DEXTROSE 5% around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8301977
Spain	505116
Bosnia and Herzegovina	97190

Supplementary Protection Certificates for FLOXIN IN DEXTROSE 5%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606

FLOXIN IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ofloxacin (FLOXIN IN DEXTROSE 5%)

Introduction to Ofloxacin

Ofloxacin, marketed under the brand name Floxin among others, is a fluoroquinolone antibiotic used to treat various bacterial infections. It is available in oral, intravenous, and topical forms, making it a versatile treatment option.

Market Size and Forecast

The ofloxacin market has been growing at a significant pace over the last few years and is expected to continue this trend. The market growth is driven by the increasing prevalence of bacterial infections, rising sources of infections, and the growing resistance of bacteria to existing antibiotics[1].

Key Drivers of Market Growth

• Increasing Prevalence of Infectious Diseases: The rise in infectious diseases such as bronchitis, pneumonia, and infections of the skin, reproductive organs, bladder, urinary tract, and prostate is a major driver of the ofloxacin market[1].
• Emergence of Multi-Drug Resistant Bacteria: The increasing occurrence of multi-drug resistant bacterial strains has heightened the need for advanced antibiotics like ofloxacin, boosting its market growth[1].
• Beneficial Properties: Ofloxacin's good oral absorption, easy tissue penetration, and broad-spectrum activity against various pathogenic bacterial strains make it a preferred choice, further accelerating market growth[1].

Market Segmentation

By Type

• Oral: This segment holds the largest share due to its high bioavailability (98% for both oral and IV routes) and availability in various tablet strengths (200mg, 300mg, and 400mg)[1].
• Intravenous Therapy (IV): Approved for marketing in 1992, this form is crucial for severe infections requiring immediate treatment[4].
• Topical (Eye Drops & Ear Drops): Used for infections of the eyes and ears, this segment also contributes significantly to the market[1].

By Distribution Channel

• Hospital Pharmacies: This segment holds the largest share as ofloxacin is a prescription drug that often requires consultation with a physician before administration[1].
• Retail Pharmacies: Also a significant channel, especially for outpatient treatments.
• Online Pharmacies: Growing in importance due to convenience and accessibility.

By Geography

• North America: Currently holds the largest market share due to the region's advanced healthcare system and preference for branded products[1].
• Asia Pacific: Expected to grow at the highest CAGR due to the large population base and increasing prevalence of infectious diseases[1].

Challenges and Restraints

• Adverse Effects: Ofloxacin is associated with serious adverse effects such as tendon rupture, especially in older patients and those taking corticosteroids, and muscle weakness in myasthenia gravis patients. These risks can hamper market growth[1][4].
• Competition from Other Antibiotics: The introduction of levofloxacin, the levo-enantiomer of ofloxacin, by companies like Johnson & Johnson has cannibalized the market share of ofloxacin[4].

Competitive Landscape

The ofloxacin market is competitive with several major players:

• Novartis
• Teva
• Allergan
• Apotex
• Janssen
• Daiichi Sankyo
• Cadila Pharmaceuticals
• Bestochem
• Almatica Pharma
• Meda Pharmaceuticals Inc.

These companies are continuously developing strategies to maintain and increase their market share[1].

Financial Trajectory

The financial performance of ofloxacin has been influenced by several factors:

• Initial Market Challenges: When first launched, ofloxacin was categorized as a "1C" drug, indicating little or no therapeutic gain over existing therapies. This made the market difficult to penetrate[4].
• Sales Performance: Despite initial challenges, ofloxacin has seen significant sales. For example, Johnson & Johnson's annual sales of Floxin were about $30 million in 2003, while combined sales of Levaquin (levofloxacin) and Floxin exceeded $1.15 billion in the same year[4].
• Market Withdrawal: Johnson & Johnson withdrew the marketing application for Floxin in 2009, which impacted the drug's financial trajectory[4].

Global Impact of Antibiotic Resistance

The broader context of antibiotic resistance significantly affects the financial trajectory of antibiotics like ofloxacin. The economic impact of inaction against antibiotic resistance is estimated to be as high as $100 trillion by 2050 if current trends continue. This highlights the critical need for continued investment in antibiotic research and development[3].

Future Opportunities

Despite the challenges, the ofloxacin market is expected to generate significant opportunities:

• Growing Awareness and Prevalence of New Infectious Diseases: Increasing awareness and the emergence of new infectious diseases with bacterial resistance are expected to drive demand for effective antibiotics like ofloxacin[1].
• Need for Advanced Drugs: The ongoing need for advanced drugs to combat multi-drug resistant bacteria will continue to fuel the growth of the ofloxacin market.

Key Takeaways

• The ofloxacin market is driven by the increasing prevalence of bacterial infections and the emergence of multi-drug resistant bacterial strains.
• The market is segmented by type, distribution channel, and geography, with oral forms and hospital pharmacies holding significant shares.
• Despite challenges such as adverse effects and competition, the market is expected to grow due to the need for effective antibiotics.
• The financial trajectory of ofloxacin has been influenced by initial market challenges, sales performance, and market withdrawal.
• The broader issue of antibiotic resistance underscores the importance of continued investment in antibiotic R&D.

Frequently Asked Questions

Q: What are the primary drivers of the ofloxacin market? A: The primary drivers include the increasing prevalence of bacterial infections, the emergence of multi-drug resistant bacterial strains, and the beneficial properties of ofloxacin such as good oral absorption and broad-spectrum activity.

Q: What are the different forms in which ofloxacin is available? A: Ofloxacin is available in oral, intravenous, and topical forms (eye drops and ear drops).

Q: Which region is expected to grow at the highest CAGR in the ofloxacin market? A: The Asia Pacific region is expected to grow at the highest CAGR due to the large population base and increasing prevalence of infectious diseases.

Q: What are some of the adverse effects associated with ofloxacin? A: Ofloxacin is associated with serious adverse effects such as tendon rupture and muscle weakness in myasthenia gravis patients.

Q: How does the emergence of antibiotic resistance impact the ofloxacin market? A: The emergence of antibiotic resistance increases the demand for effective antibiotics like ofloxacin, driving market growth, but also highlights the need for continued investment in antibiotic R&D to combat resistance.

Cited Sources:

1. Verified Market Research - Ofloxacin Market Size | Share | Industry Analysis | Trends | Forecast
2. Frontiers in Cellular and Infection Microbiology - Characterization of Cellulomonas sp. HM71 as potential ...
3. AMR Review - Tackling drug-resistant infections globally
4. Wikipedia - Ofloxacin
5. Alabama State Health Planning and Development Agency - AL2024-026 Applicant: The Health Care Authority of the ...