CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cipro In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Cipro In Dextrose 5% In Plastic Container is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER is ciprofloxacin. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cipro In Dextrose 5% In Plastic Container

A generic version of CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as ciprofloxacin by BAXTER HLTHCARE CORP on April 29^th, 2008.

Summary for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
DailyMed Link:	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990		DISCN	Yes	No
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-002	Dec 26, 1990		DISCN	Yes	No

Expired US Patents for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	4,670,444*PED
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	4,957,922*PED
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	4,705,789*PED
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	4,808,583*PED

International Patents for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	190890
Finland	78689
Malaysia	8700363	7-AMINO-1-GYCLOPROPYL-4-OXO-1, 4-DIHYDRONAPHTHYRIDINE-3-CARBOXYLIC ACIDS, PROCESS FOR THEIR PREPARATION AND MEDICAMENTS CONTAINING THESE COMPOUNDS
Poland	262006
Singapore	21489

Supplementary Protection Certificates for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

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	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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 Ophthalmic Solution and Related Formulations

Introduction to Ciprofloxacin

Ciprofloxacin, a fluoroquinolone antibiotic, is widely used to treat various bacterial infections, including those affecting the eyes. The market for ciprofloxacin, particularly in its ophthalmic solution form, is driven by several key factors.

Market Size and Growth Forecast

The global ciprofloxacin ophthalmic solution market was valued at USD 160.46 million in 2023 and is projected to reach USD 244.40 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024 to 2031[1].

Drivers of Market Growth

Increasing Prevalence of Eye Infections

The widespread occurrence of bacterial eye infections such as conjunctivitis and corneal ulcers significantly drives the demand for ciprofloxacin ophthalmic solutions. These conditions require potent antibiotics to prevent complications and preserve vision, making ciprofloxacin a crucial treatment option[1].

Government Initiatives and Healthcare Policies

Government initiatives and healthcare policies aimed at improving eye health and reducing the burden of infectious diseases also contribute to the market growth. These policies often include subsidies, public awareness campaigns, and investments in healthcare infrastructure, which enhance the accessibility and affordability of ciprofloxacin ophthalmic solutions[1].

Market Segmentation

Type

The market is segmented into branded and generic ciprofloxacin ophthalmic solutions. Generic versions, being more cost-effective, are gaining traction and contributing to the overall market growth[1].

Dosage

The dosage segmentation includes 1-2 drops every 2 hours, 2 drops every 15 minutes, and 2 drops every 30 minutes. The flexibility in dosing regimens helps in catering to different patient needs and preferences[1].

Application

Ciprofloxacin ophthalmic solutions are primarily used to treat corneal ulcers and bacterial conjunctivitis. The effectiveness of ciprofloxacin in these applications ensures a steady demand for the product[1].

End-Users

The end-users include hospitals, homecare settings, specialty clinics, and others. The increasing adoption in homecare settings, due to the ease of administration and patient convenience, is a significant growth driver[1].

Distribution Channel

The distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies. The rise of online pharmacies has expanded the reach and accessibility of ciprofloxacin ophthalmic solutions, contributing to market growth[1].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increased investments in healthcare infrastructure and rising awareness about eye health. This region is driving demand for advanced treatments and therapies, including ciprofloxacin ophthalmic solutions[1].

North America

North America is expected to dominate the market due to its advanced healthcare infrastructure and robust medical facilities. The widespread adoption of ciprofloxacin ophthalmic solutions in this region is driven by technological advancements and the availability of high-quality medical care[1].

Supply Chain and Manufacturing

Global Dependence on API Sources

The production of ciprofloxacin, like many other pharmaceuticals, is heavily dependent on Active Pharmaceutical Ingredients (APIs) sourced from countries like China and India. This dependence poses risks related to supply chain disruptions and quality control issues[2].

Resilience of Domestic Manufacturing

The resilience of the U.S. manufacturing base for APIs is a critical factor in ensuring a stable supply of ciprofloxacin. However, the current reliance on foreign sources highlights the need for strengthening domestic manufacturing capabilities to mitigate potential risks[2].

Financial Implications

Cost-Effectiveness

Ciprofloxacin can be more cost-effective than traditional parenteral regimens in selected clinical settings. This cost-effectiveness, combined with its efficacy, makes it a preferred choice for treating bacterial infections, contributing to its financial growth[4].

Pricing and Regulatory Framework

The pricing of ciprofloxacin ophthalmic solutions is influenced by regulatory frameworks, patient epidemiology, and pipeline analysis. Regulatory bodies play a crucial role in ensuring the quality and safety of these products, which can impact their market price and adoption[1].

Clinical Pharmacology and Safety

Pharmacokinetics

Ciprofloxacin has a well-understood pharmacokinetic profile, with an elimination half-life of approximately 4 hours. It is excreted primarily through the urine, with a significant portion also excreted through the feces. This profile ensures effective treatment with minimal side effects[3][4].

Drug Interactions

Ciprofloxacin can interact with other drugs, particularly those metabolized by the CYP1A2 enzyme. These interactions can lead to increased plasma concentrations of other drugs, necessitating careful monitoring and dosage adjustments[3][4].

Enhancing Healthcare Outcomes

Patient Compliance and Treatment Efficacy

The ease of administration and the effectiveness of ciprofloxacin ophthalmic solutions enhance patient compliance and treatment outcomes. This is particularly important in homecare settings where patients may need to self-administer the medication[1].

Resistance and Empiric Therapy

The increasing resistance to ciprofloxacin, especially in hospital settings, necessitates careful evaluation and case-by-case consideration for its use as empiric therapy. This ensures that the antibiotic remains effective while minimizing the risk of resistance[4].

Key Takeaways

• The global ciprofloxacin ophthalmic solution market is projected to grow from USD 160.46 million in 2023 to USD 244.40 million by 2031.
• The market is driven by the increasing prevalence of eye infections, government initiatives, and advancements in healthcare infrastructure.
• The Asia-Pacific region is expected to show significant growth, while North America will continue to dominate the market.
• The supply chain for ciprofloxacin APIs is heavily dependent on foreign sources, highlighting the need for strengthening domestic manufacturing.
• Ciprofloxacin remains a cost-effective and clinically effective treatment option, but its use must be carefully managed to mitigate resistance.

FAQs

What is the projected market size of ciprofloxacin ophthalmic solutions by 2031?

The global ciprofloxacin ophthalmic solution market is projected to reach USD 244.40 million by 2031[1].

What are the primary drivers of the ciprofloxacin ophthalmic solution market?

The market is driven by the increasing prevalence of eye infections, government initiatives, and advancements in healthcare infrastructure[1].

Which region is expected to show significant growth in the ciprofloxacin ophthalmic solution market?

The Asia-Pacific region is expected to show significant growth during the forecast period[1].

What are the common applications of ciprofloxacin ophthalmic solutions?

Ciprofloxacin ophthalmic solutions are primarily used to treat corneal ulcers and bacterial conjunctivitis[1].

How does ciprofloxacin interact with other drugs?

Ciprofloxacin can interact with other drugs, particularly those metabolized by the CYP1A2 enzyme, leading to increased plasma concentrations of these drugs[3][4].

Sources

1. Data Bridge Market Research: Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
2. FDA: Safeguarding Pharmaceutical Supply Chains in a Global Economy.
3. FDA: CIPRO I.V. - accessdata.fda.gov.
4. NCBI Bookshelf: Ciprofloxacin - StatPearls.