CILOXAN Drug Patent Profile

When do Ciloxan patents expire, and what generic alternatives are available?

Ciloxan is a drug marketed by Sandoz and is included in two NDAs.

The generic ingredient in CILOXAN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciloxan

A generic version of CILOXAN was approved as ciprofloxacin hydrochloride by RUBICON on June 9^th, 2004.

Summary for CILOXAN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	6
Patent Applications:	3,456
Drug Prices:	Drug price information for CILOXAN
Drug Sales Revenues:	Drug sales revenues for CILOXAN
What excipients (inactive ingredients) are in CILOXAN?	CILOXAN excipients list
DailyMed Link:	CILOXAN at DailyMed

See drug prices for CILOXAN

See drug sales revenues for CILOXAN

Recent Clinical Trials for CILOXAN

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

Sponsor	Phase
National University of Malaysia	Phase 1/Phase 2
Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2
CR-CSSS Champlain-Charles-Le Moyne	Phase 3

See all CILOXAN clinical trials

Pharmacology for CILOXAN

Drug Class	Fluoroquinolone Antibacterial
Mechanism of Action	Cytochrome P450 1A2 Inhibitors

US Patents and Regulatory Information for CILOXAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992-001	Dec 31, 1990	AT	RX	Yes	Yes
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998		RX	Yes	Yes

Expired US Patents for CILOXAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992-001	Dec 31, 1990

International Patents for CILOXAN

See the table below for patents covering CILOXAN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1237431	ACIDE 1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7- CHLORO-QUINOLEINE-3-CARBOXYLIQUE; SES ESTERS ET METHODE DE PREPARATION (1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7-CHLORO- QUINOLINE-3-CARBOXYLIC ACID, ESTERS AND PROCESS FOR THEIR PREPARATION)
Japan	S5874667	1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7- PIPERAZINOQUINOLINE-3-CARBOXYLIC ACIDS
Singapore	44685

Supplementary Protection Certificates for CILOXAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	122012000070	Germany		PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
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
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003

Market Dynamics and Financial Trajectory for Ciprofloxacin (CILOXAN)

Introduction to Ciprofloxacin (CILOXAN)

Ciprofloxacin, commonly known by the brand name CILOXAN, is a broad-spectrum antibiotic belonging to the fluoroquinolone class. It is widely used to treat various bacterial infections, including those affecting the urinary tract, eyes, and other parts of the body.

Market Drivers

Increasing Prevalence of Infections

The market for ciprofloxacin is driven by the increasing prevalence of bacterial infections, particularly those affecting the urinary tract and eyes. The higher efficacy of ciprofloxacin in treating urinary tract infections (UTIs) and renal infections due to its high concentration in the renal system is a significant factor[1].

Government Initiatives and Healthcare Policies

Government initiatives and healthcare policies aimed at improving healthcare infrastructure and increasing awareness about safe drug utilization also contribute to the market growth. In regions like Asia-Pacific, increased investments in healthcare infrastructure are driving the demand for advanced treatments, including ciprofloxacin ophthalmic solutions[4].

Market Segmentation

Application

Ciprofloxacin is used in various applications, including:

• Urinary Tract Infections: Its high efficacy in treating UTIs and renal infections makes it a preferred choice.
• Eye Infections: Ciprofloxacin ophthalmic solutions are used to treat bacterial conjunctivitis and corneal ulcers[4].
• Other Bacterial Infections: It is also used for treating other bacterial infections such as acute otitis externa, as seen in Amneal's recent FDA approval for a ciprofloxacin and dexamethasone otic suspension[3].

Dosage Forms

Ciprofloxacin is available in various dosage forms, including:

• Tablets and Oral Suspensions: For systemic infections.
• Ophthalmic Solutions: For eye infections.
• Otic Suspensions: For ear infections[4].

Distribution Channels

The drug is distributed through:

• Hospital Pharmacies
• Online Pharmacies
• Retail Pharmacies These channels ensure widespread availability and accessibility of the medication[4].

Geographical Performance

North America

North America dominates the global ciprofloxacin market due to its advanced healthcare infrastructure and higher preferences for preventive healthcare. However, stringent government regulations and increased awareness about adverse drug reactions have narrowed the growth path in this region[1].

East Asia

East Asia is expected to show a considerably higher market growth rate due to the higher utilization of ciprofloxacin in treating renal infections. This region is also seeing increased investments in healthcare infrastructure, driving the demand for advanced treatments[1].

Asia-Pacific

The Asia-Pacific region is anticipated to grow significantly during the forecast period, driven by rising awareness about eye health and increased regional investments in healthcare infrastructure[4].

Financial Trajectory

Revenue Growth

The global ciprofloxacin market is projected to experience significant revenue growth. For instance, the ciprofloxacin ophthalmic solution market is expected to grow from USD 160.46 million in 2023 to USD 244.40 million by 2031, with a CAGR of 5.4% during the forecast period[4].

Cost and Margins

Generics, such as those approved by Amneal, typically offer lower margins than branded drugs but can achieve significant volume sales. This can lead to increased revenue streams despite lower margins per unit[3].

Regulatory Impact

The financial trajectory is also influenced by regulatory actions. For example, the US FDA's black box warning on fluoroquinolones, including ciprofloxacin, due to safety concerns, is anticipated to reduce revenue generation. However, companies like Amneal are navigating these regulatory challenges effectively, as seen in their recent FDA approval for a ciprofloxacin and dexamethasone otic suspension[1][3].

Challenges and Restraints

Regulatory Impositions

High regulatory impositions and safety warnings, such as the black box warning issued by the US FDA, are projected to restrain the growth of the ciprofloxacin market. These warnings highlight the potential adverse reactions of the drug, particularly on tendons and skin in children and elderly patients[1].

Adverse Drug Reactions

The awareness about adverse drug reactions is increasing, which can impact the market negatively. However, this also drives the need for safer and more effective formulations, presenting opportunities for innovation and growth[1].

Opportunities and Innovations

Advanced Formulations

The market is experiencing continual advancement driven by research and innovation, leading to enhanced formulations and delivery mechanisms. This improves efficacy, patient experience, and treatment precision, contributing to sustained market growth[4].

Generic Market

The approval of generic versions of ciprofloxacin, such as Amneal's recent approval, can lead to significant volume sales and increased market penetration. Generics can quickly erode the sales of their branded counterparts post-patent expiry, reshuffling market shares and attracting investor interest[3].

Key Takeaways

• Increasing Demand: The market is driven by the increasing prevalence of bacterial infections, particularly UTIs and eye infections.
• Geographical Growth: North America dominates the market, but East Asia and the Asia-Pacific region are expected to show significant growth.
• Regulatory Impact: Regulatory impositions and safety warnings can restrain market growth but also drive innovation.
• Financial Growth: The market is projected to experience significant revenue growth, with generics playing a crucial role in volume sales.
• Innovation: Advanced formulations and delivery mechanisms are improving treatment outcomes and driving market growth.

FAQs

What are the primary applications of ciprofloxacin?

Ciprofloxacin is primarily used to treat urinary tract infections, eye infections such as conjunctivitis and corneal ulcers, and other bacterial infections like acute otitis externa.

How does the regulatory environment impact the ciprofloxacin market?

The regulatory environment, including black box warnings and stringent government regulations, can restrain market growth but also drives companies to innovate and ensure safer drug utilization.

What is the expected growth rate of the ciprofloxacin ophthalmic solution market?

The ciprofloxacin ophthalmic solution market is expected to grow at a CAGR of 5.4% from 2023 to 2031, reaching USD 244.40 million by 2031.

How do generic versions of ciprofloxacin impact the market?

Generic versions of ciprofloxacin can achieve significant volume sales despite lower margins, leading to increased revenue streams and market penetration.

Which regions are expected to drive the growth of the ciprofloxacin market?

North America currently dominates the market, but East Asia and the Asia-Pacific region are expected to show significant growth due to increased investments in healthcare infrastructure and rising awareness about eye health.

Sources

1. Persistence Market Research: Ciprofloxacin Market.
2. CI Financial Corp.: CI Financial Corp. Q4 2023 Earnings Call.
3. Stock Titan: Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone.
4. Data Bridge Market Research: Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.