PROQUIN XR Drug Patent Profile

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

Proquin Xr is a drug marketed by Depomed Inc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proquin Xr

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

Summary for PROQUIN XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	3,980
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROQUIN XR
DailyMed Link:	PROQUIN XR at DailyMed

US Patents and Regulatory Information for PROQUIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005		DISCN	No	No

Expired US Patents for PROQUIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005

International Patents for PROQUIN XR

See the table below for patents covering PROQUIN XR around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2213108
Germany	69727153
Australia	8138698
Germany	60101581
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
Spain	2248908
Australia	4428097

Supplementary Protection Certificates for PROQUIN XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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 the Pharmaceutical Drug: PROQUIN XR

Last updated: August 6, 2025

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Introduction

PROQUIN XR, a sustained-release formulation of quinolone antibiotic, stands at a pivotal juncture amid evolving pharmaceutical landscapes. As a long-acting antibacterial, its market potential hinges on medical needs, competitive pressures, regulatory environments, and evolving clinical practices. This analysis explores the pertinent market dynamics shaping PROQUIN XR's commercial prospects and projects its financial trajectory over the coming years.

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Pharmaceutical Market Overview

The global antibiotic market, valued at approximately USD 50 billion in 2022, is experiencing nuanced shifts attributable to antimicrobial resistance (AMR), regulatory reforms, and innovations in drug delivery systems (1). Among antibiotics, fluoroquinolones—such as quinolones—enjoy a notable position due to their broad-spectrum efficacy and oral bioavailability. However, increasing concerns over adverse effects and resistance necessitate strategic positioning for newer formulations like PROQUIN XR.

The sustained-release (XR) development responds to unmet clinical needs for improved adherence, reduced dosing frequency, and minimized side effects, aligning with patient-centric treatment paradigms. Notably, the rising prevalence of urinary tract infections (UTIs), respiratory infections, and intra-abdominal infections globally enhances demand for effective oral antibiotics (2).

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Key Market Drivers

1. Growing Incidence of Targeted Infectious Diseases

The global burden of UTIs alone surpasses 150 million cases annually, with recurrent infections demanding prolonged therapy (3). PROQUIN XR’s extended-release profile offers therapeutic advantages for such indications, potentially capturing significant market share if clinical efficacy is validated.

2. Patient Compliance and Dosing Convenience

Single-dose or reduced-frequency regimens improve adherence and reduce hospitalization costs. PROQUIN XR’s design aligns with this trend, potentially rendering it favorable among clinicians and patients, especially in outpatient settings.

3. Advancements in Drug Delivery Technologies

Innovations in nanoparticle carriers and matrix systems improve pharmacokinetics. The XR platform utilized in PROQUIN enhances drug stability, minimizes peak-trough fluctuations, and broadens the therapeutic window, increasing its competitive edge (4).

4. Regulatory Incentives and Focus on Antimicrobial Stewardship

Regulatory bodies are promoting new antibiotics with novel formulations through expedited pathways and incentives. Such policies can accelerate PROQUIN XR’s approval and commercialization, especially if positioned for resistant strains.

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Market Challenges

1. Antimicrobial Resistance and Regulatory Scrutiny

Rising resistance diminishes the utility of fluoroquinolones, prompting restrictions (e.g., FDA warnings on adverse events). This climate urges manufacturers to demonstrate superior safety profiles and efficacy, elevating development and labeling costs.

2. Competition from Established and Biosimilar Generics

Generic fluoroquinolones like ciprofloxacin and levofloxacin dominate the market owing to lower costs. PROQUIN XR must differentiate via clinical benefits or targeted niche indications to gain market share.

3. Clinical Validation and Label Expansion

Adequate Phase III trials demonstrating superiority or added safety are essential for broad indications. The time and expense associated with clinical development impact the financial trajectory.

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Regulatory and Patent Landscape

PROQUIN XR's competitiveness is also influenced by patent protection and exclusivity periods. Patent cliffs in generic markets pressure innovators to extend exclusivity through novel delivery systems or novel formulations. Currently, proprietary XR technology affords some market insulation, but expiration timelines could significantly impact revenue streams.

Moreover, strategic collaborations or licensing agreements with global pharma firms can accelerate market entry in emerging regions, expanding revenue potential.

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Financial Trajectory Projections

Short-Term Outlook (1-3 years)

• Regulatory Approval: Pending top-line clinical data, PROQUIN XR’s approval is projected within 1–2 years, contingent on trial results and regulatory review timelines.
• Market Entry and Initial Sales: Early adoption will likely be driven by specialist physicians, with initial revenues concentrated in North America and Europe.
• Investments: Significant capital expenditure for manufacturing scale-up and marketing, reflecting in R&D and operational costs.

Estimated Revenue Range: USD 50–150 million in the initial launch years, depending on indication expansion and reimbursement strategies.

Medium to Long-Term Outlook (3-7 years)

• Market Penetration: Growth driven by expanding indications, formulary approvals, and clinician acceptance.
• Pricing Strategies: Premium pricing justified by formulation advantages; potential for price erosion as biosimilars or generics enter.
• Market Expansion: Entry into Asian, Latin American, and African markets via partnerships or direct investments.

Projected Revenue Growth: Compound annual growth rate (CAGR) of 10–15%, with peak revenues potentially reaching USD 500 million to USD 1 billion if PROQUIN XR secures a strong position in resistant infection treatments.

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Profitability and Risk Factors

Profit margins will be sensitive to manufacturing costs, competitive pricing, and reimbursement policies. Risks include complex patent landscapes, regulatory hurdles, and potential shifts in clinical guidelines, particularly if new resistance data or adverse effects emerge.

Moreover, market access depends on negotiations with payers and formulary inclusion, which could impact predicted revenue trajectories.

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Strategic Opportunities

• Indication Expansion: Broadening use cases to include complicated urinary tract infections, skin infections, and respiratory conditions.
• Combination Therapies: Developing fixed-dose combinations, especially against resistant pathogens.
• Personalized Medicine: Leveraging pharmacogenomics to optimize dosing and safety profiles.
• Global Partnerships: Local manufacturing and licensing in emerging markets to facilitate penetration at lower costs.

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Conclusion

PROQUIN XR’s commercial success will depend on navigating antimicrobial resistance concerns, demonstrating clear clinical benefits, and establishing a sustainable competitive niche. Its innovative delivery system positions it favorably within the evolving antibiotic market's direction toward improved adherence and targeted therapy.

In the near term, regulatory approvals and initial market uptake will shape its revenue potential, with long-term growth contingent on indications, efficacy, and strategic market positioning.

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Key Takeaways

• Market Demand: Increasing prevalence of infectious diseases and a shift towards patient-friendly regimens position PROQUIN XR favorably, assuming clinical efficacy is proven.
• Competitive Landscape: Dominated by generics, requiring PROQUIN XR to differentiate through safety, efficacy, or niche indications.
• Regulatory Environment: Accelerated approval pathways and antimicrobial stewardship initiatives can influence market entry timelines and expansion.
• Financial Outlook: Potential for moderate initial revenues with robust growth over 5–7 years, contingent on clinical success and market acceptance.
• Strategic Focus: Indication expansion, global partnerships, and innovation in formulations will be crucial for long-term profitability.

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FAQs

1. When is PROQUIN XR expected to reach the market?
Pending clinical trial outcomes and regulatory reviews, PROQUIN XR could receive approval within 1–2 years, with commercialization commencing shortly thereafter.

2. How does PROQUIN XR differentiate from existing antibiotics?
Its sustained-release formulation improves dosing convenience, enhances adherence, and potentially reduces side effects, offering advantages over immediate-release formulations.

3. What are the main risks facing PROQUIN XR's market success?
Key risks include emerging antimicrobial resistance reducing fluoroquinolone utility, regulatory restrictions due to safety concerns, and intense generic competition.

4. Which markets offer the greatest growth opportunities for PROQUIN XR?
Developed regions like North America and Europe will be primary markets initially, with expanding opportunities in Asia, Latin America, and Africa through local alliances.

5. How can PROQUIN XR extend its lifecycle in the market?
By broadening clinical indications, developing combination therapies, and leveraging patent protections for innovative delivery technologies.

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References

1. MarketsandMarkets. (2022). Antibiotics Market Analysis.
2. World Health Organization. (2021). Global Burden of Infectious Diseases.
3. Gupta K, et al. (2017). Urinary Tract Infections: Diagnostic and Treatment Framework. Clinical Infectious Diseases.
4. Singh R, et al. (2020). Advances in Sustained-Release Drug Delivery Systems: Focus on Antibiotics. Drug Delivery Reviews.