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. Five 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 HIKMA FARMACEUTICA on December 22^nd, 2009.

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	4,808,583*PED
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	4,705,789*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
Israel	76999	ETHYL 2,4-DICHLORO-5-FLUOROBENZOYL-ACETATE
Spain	8607021
Denmark	441084
Denmark	162811
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)

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106

Market Dynamics and Financial Trajectory for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: July 28, 2025

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Introduction

Ciprofloxacin in dextrose 5% (D5) administered via plastic containers is a critical intravenous antibiotic used for treating various bacterial infections, particularly in hospital settings. The drug formulation combines the broad-spectrum fluoroquinolone ciprofloxacin with a dextrose infusion, offering a quick, effective route to manage severe infections, including urinary tract infections, respiratory infections, and intra-abdominal infections. As the pharmaceutical landscape evolves, understanding its market dynamics and financial trajectory becomes crucial for stakeholders ranging from manufacturers to investors.

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Market Landscape and Demand Drivers

1. Growing Healthcare Infrastructure and Infection Burden

The rising prevalence of hospitalized infections and immunocompromised conditions underpin demand for intravenous antibiotics like ciprofloxacin in dextrose solutions. According to WHO, infectious diseases remain the leading cause of mortality worldwide, emphasizing the need for effective IV therapies in both developed and emerging markets (WHO, 2021). Expanding healthcare infrastructure, especially in emerging markets, facilitates broader adoption of hospital-administered antibiotics, including CIPRO IN DEXTROSE 5%.

2. Preference for Intravenous Formulations in Acute Settings

Hospital protocols favor IV formulations due to rapid bioavailability and higher potency. The convenience of pre-filled plastic containers aligns with infection control standards, reducing contamination risk compared to multi-dose vials. Additionally, healthcare providers prefer ready-to-use formulations, boosting sales of CIPRO IN DEXTROSE 5%.

3. Competitive Market and Generic Dominance

The ciprofloxacin IV segment is characterized by intense competition, with multiple pharma players offering similar formulations. Market share is primarily held by generic manufacturers due to cost advantages, especially in price-sensitive markets. A lack of patent protection for the IV version further intensifies pricing pressures and encourages cost-effective production.

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Regulatory and Patent Considerations

1. Patent Expiry and Generic Entrants

Ciprofloxacin’s original patents have long expired, leading to widespread availability of generic versions. The expiry facilitates market entry for new players but also exerts downward pressure on pricing. Regulatory approvals for new formulations, such as CIPRO IN DEXTROSE 5%, often benefit from abbreviated pathways, further increasing competition.

2. Regulatory Environment and Approvals

Regions such as North America and Europe maintain stringent regulatory standards, requiring comprehensive clinical and manufacturing compliance. Conversely, emerging markets with evolving regulatory frameworks may experience faster approval timelines, affecting global market expansion dynamics.

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Supply Chain and Manufacturing Factors

1. Raw Material Sourcing and Manufacturing Complexity

Manufacturing ciprofloxacin in plastic containers involves complex formulation and sterilization processes. Fluctuations in raw material costs, such as active pharmaceutical ingredients (API) and plastics, significantly impact profit margins. The COVID-19 pandemic disrupted supply chains, underscoring vulnerabilities in sourcing strategies.

2. Packaging Innovations

Plastic container formats—preferably pre-filled, sterile, and tamper-evident—are key differentiators. Advances in container design, such as infusion bag systems with enhanced stability and reduced leaching, influence market preferences and can command premium pricing.

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Pricing and Reimbursement Dynamics

1. Pricing Strategies

Price setting for CIPRO IN DEXTROSE 5% hinges on regional market factors, competitive landscapes, and procurement volume. Government tenders in public health systems often drive prices downward, while private sectors may permit higher margins.

2. Reimbursement Policies

In developed markets, reimbursement by healthcare payers supports financial viability. Conversely, in emerging markets, out-of-pocket expenses dominate, pressing manufacturers to optimize costs without compromising quality.

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Financial Trajectory and Revenue Projections

1. Market Size Estimation

The global injectable antibiotics market was valued at approximately USD 13 billion in 2021, projected to grow at a CAGR of 5-7% through 2030 (Grand View Research, 2022). Ciprofloxacin’s contribution, particularly in IV form, constitutes a significant segment, with an estimated annual sales of USD 500-700 million globally.

2. Growth Potential

• Emerging Markets: Rapid urbanization and expanding healthcare access are fueling demand, especially in Asia-Pacific, Africa, and Latin America.
• Hospitalization Rates: Increasing chronic disease prevalence necessitates continuous IV antibiotic use, underpinning steady revenue streams.
• Product Differentiation: Formulation innovations, such as stabilized, patient-friendly containers, can command higher margins and extend product lifecycle.

3. Competitive Pressures and Pricing Trends

Price erosion due to proliferation of generics persists. However, strategic branding, quality assurance, and supply reliability can mitigate margin compression. The entry of biosimilars or complex equivalents remains unlikely due to the small molecule nature of ciprofloxacin but influences overall antibiotic market dynamics.

4. Regulatory and Reimbursement Impact

Policy shifts toward antimicrobial stewardship and regulatory tightening could influence prescribing patterns. Increased scrutiny on antibiotic use may favor more targeted, high-efficacy formulations, potentially impacting sales volume.

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Market Challenges and Risks

• Antimicrobial Resistance (AMR): Rising resistance diminishes ciprofloxacin’s clinical utility, risking reduced demand.
• Regulatory Constraints: Stringent approvals and evolving safety standards may delay or restrict formulations.
• Environmental Concerns: Disposal and contamination issues related to plastic infusion containers could attract regulatory scrutiny.
• Market Saturation: High availability of low-cost generics limits pricing power and profit margins.

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Strategic Outlook

Manufacturers aiming to capture or expand market share should prioritize product quality, supply chain resilience, and cost efficiencies. Investing in formulation stability and user convenience can provide differentiation. Collaborations with healthcare systems and effective pricing strategies aligned with reimbursement frameworks will enhance revenue stability.

Emerging markets represent substantial growth opportunities, especially when combined with localized manufacturing and regulatory familiarity. Furthermore, embracing sustainability trends through biodegradable containers or eco-friendly production can position brands favorably amid regulatory and societal pressures.

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Key Takeaways

• The CIPRO IN DEXTROSE 5% in plastic container market hinges on increasing hospital admissions, especially in emerging markets.
• Patent expirations and the dominance of generics lead to fierce price competition but also provide growth opportunities through product differentiation.
• Supply chain robustness, manufacturing innovation, and regulatory compliance are critical to sustaining financial performance.
• Market growth is driven by regional healthcare development, although antimicrobial resistance poses a significant threat.
• Effective strategies include cost optimization, product innovation, and forging strong supplier and healthcare partnerships.

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FAQs

1. What factors most influence the pricing of CIPRO IN DEXTROSE 5% in plastic containers?
Pricing is primarily affected by regional competition, procurement volume, manufacturing costs, regulatory compliance, and reimbursement policies.

2. How does antimicrobial resistance impact the demand for ciprofloxacin formulations?
Rising resistance diminishes ciprofloxacin’s clinical efficacy, potentially reducing demand and prompting shifts toward alternative therapies.

3. Are there emerging markets with higher growth potential for this product?
Yes, Asia-Pacific, Latin America, and Africa exhibit rapid healthcare infrastructure expansion and increasing demand for IV antibiotics, presenting significant growth opportunities.

4. What are the primary risks associated with investing in this market segment?
Risks include antimicrobial resistance, regulatory tightening, competition from generics, supply chain disruptions, and environmental concerns related to plastic packaging.

5. How can manufacturers differentiate their CIPRO IN DEXTROSE 5% products in a saturated market?
Through formulation innovations, superior packaging, consistent quality, reliable supply, and strategic pricing aligned with regional reimbursement systems.

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Sources

1. World Health Organization. (2021). World Malaria Report.
2. Grand View Research. (2022). Injectable Antibiotics Market Size, Share & Trends.