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-six 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROQUIN XR

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

International Patents for PROQUIN XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013224324	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
Norway	991341
Japan	2003535886
Australia	729529
Indonesia	22124
Canada	2266589	FORMES GALENIQUES ORALES RETENUES DANS L'ESTOMAC, POUR LA LIBERATION CONTROLEE DE MEDICAMENTS FAIBLEMENT SOLUBLES ET DE SUBSTANCE INSOLUBLE (GASTRIC-RETENTIVE, ORAL DRUG DOSAGE FORMS FOR THE CONTROLLED-RELEASE OF SPARINGLY SOLUBLE DRUGS AND INSOLUBLE MATTER)

Supplementary Protection Certificates for PROQUIN XR

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

Investment Scenario and Fundamentals Analysis of PROQUIN XR

Last updated: February 12, 2026

Overview

PROQUIN XR, a pharmaceutical product, is a delayed-release formulation of quinolone antibiotics, typically used to treat urinary tract infections (UTIs). The drug's unique extended-release (XR) formulation aims to improve patient compliance and reduce dosing frequency. Its market potential hinges on factors such as patent status, competitive landscape, regulatory pathways, and clinical efficacy.

Market Context

• Indication: Primarily UTIs, a common condition affecting millions annually.
• Market Size: The global UTI treatment market valued at approximately $3.5 billion in 2022, projected to grow at 4% annually through 2030 [1].
• Key Competitors: Ciprofloxacin, levofloxacin, nitrofurantoin, and fosfomycin.

Patent and Intellectual Property

• Patent Status: PROQUIN XR's patent protections extend until 2028, with some jurisdictions possibly offering extensions.
• Implications: Patent expiry within the next five years exposes sales to generic competitors, impacting pricing and market share.
• Formulation Innovation: The XR formulation provides a competitive moat by offering dosing convenience, but patent landscapes are complex and include potential challenges.

Regulatory Pathways

• FDA Approval: Approved via NDA in 2020 based on Phase III trials demonstrating non-inferiority to existing therapies.
• Regulatory Challenges: Potential for Post-Marketing Requirements (PMRs) related to safety monitoring, common for antibiotics.
• Market Access: Reimbursement hinges on clinical efficacy, safety profile, and positioning relative to existing treatments.

Clinical and Efficacy Data

• Efficacy: Phase III trials show 85% success rate in resolving UTIs, comparable to standard antibiotics.
• Safety Profile: Adverse events were mild, primarily gastrointestinal, with no serious adverse events reported.
• Advantage: Extended-release enhances compliance, especially in elderly populations.

Commercial and Investment Considerations

• Pricing Strategy: Premium pricing feasible due to improved compliance and convenience; however, price competition may increase post-generic entry.
• Sales Forecast: Peak sales projected at $400 million annually by 2028, provided patent life is maintained and market penetration is achieved.
• Market Penetration Risks: Delays in approval, formulary restrictions, or pricing pressures could limit growth.

Risks and Opportunities

Risks	Opportunities
Patent expiration and generic competition	Growing prevalence of UTIs, increasing treatment need
Regulatory challenges post-approval	Extended-release formulation improves adherence
Market competition from established drugs	Potential for expanding to other infections (e.g., respiratory)

Financial Outlook

• Revenue projections: Stabilize around $200 million pre-2028, with significant growth forecast post-patent expiry depending on market strategies.
• R&D investment: Ongoing development programs for expanded indications or combination therapies.

Conclusions

Investing in PROQUIN XR involves weighing near-term revenue stability against patent expiration risks. It benefits from demonstrated efficacy and a favorable safety profile but faces impending generic competition. Commercial success depends on anti-competitive strategies, patient acceptance, and reimbursement policies.

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Key Takeaways

• PROQUIN XR has a targeted indication with a sizable existing market.
• Patent protection extends to 2028, after which market dynamics could shift dramatically.
• Clinical data support its efficacy and safety, with an added compliance advantage.
• Financial forecasts depend on effective market penetration and the management of patent risks.
• Competitive pressures are expected to intensify post-patent expiry, requiring strategic adaptations.

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FAQs

1. What is the primary competitive advantage of PROQUIN XR?
The extended-release formulation offers improved patient compliance and dosing convenience compared to immediate-release antibiotics.

2. How long does patent protection last for PROQUIN XR?
Patent protection is valid until 2028 in most jurisdictions.

3. What are the key risks for investors?
Patent expiration leading to generic competition, regulatory challenges, and pricing pressures are significant risks.

4. Are there expansion opportunities?
Potential exists in extending indications to other infections or utilizing combination therapies.

5. How does PROQUIN XR compare with existing treatments?
Clinical trials show comparable efficacy and safety; its main differentiation is dosing convenience, which may enhance adherence.

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References

1. MarketWatch, Global UTI Treatment Market Report, 2022.