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
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	3,979
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	5,972,389
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,340,475
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,635,280
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,488,962

International Patents for PROQUIN XR

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

Country	Patent Number	Title	Estimated Expiration
Austria	302597
South Korea	100716756
Denmark	1294363
Norway	991341
World Intellectual Property Organization (WIPO)	9855107
European Patent Office	0941071	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)
Hong Kong	1027298

Supplementary Protection Certificates for PROQUIN XR

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

PROQUIN XR Market Analysis and Financial Projection

Last updated: February 7, 2026

What Are the Market Dynamics for PROQUIN XR?

PROQUIN XR, an extended-release formulation of ciprofloxacin, targets bacterial infections including complicated urinary tract infections and bacterial prostatitis. Its market dynamics are influenced by several factors:

Competitive Landscape:
PROQUIN XR competes with multiple antibiotics, including Bactrim DS, Levaquin, and generic ciprofloxacin. The presence of generics reduces prices but limits margins for proprietary formulations like PROQUIN XR.

Regulatory Status:
FDA approval for PROQUIN XR was granted in 2014. Its status affects market access and reimbursement strategies. The product must demonstrate clear benefits over existing treatments to maintain market penetration.

Prescribing Trends:
Doctors favor antibiotics with proven efficacy and minimal resistance issues. As antibiotic stewardship gains importance, physicians increasingly avoid broad-spectrum antibiotics like ciprofloxacin in favor of targeted therapies.

Market Size and Growth:
The global bacterial infection treatment market was valued at approximately $44 billion in 2022. Extended-release formulations like PROQUIN XR target niche segments within this broader market with steady growth projections.

Pricing and Reimbursement:
Extended-release formulations typically command higher prices. Reimbursement policies influence patient access, especially across different healthcare systems (e.g., private insurance vs. government programs). For PROQUIN XR, reimbursement stability depends on demonstrated clinical benefit and cost-effectiveness.

Patent and Exclusivity Status:
The patent protection for PROQUIN XR was filed around 2012, with exclusivity expected through at least 2022. Patent litigation or challenges could open the market to generics, impacting revenue.

What Is the Financial Trajectory for PROQUIN XR?

Sales Revenue:
Initial launch in 2014 led to modest revenues due to limited awareness and prescriber adoption. Annual sales peaked around $50 million in 2017, then declined due to generic competition and prescribing shifts.

Market Penetration:
By 2022, market share for PROQUIN XR among ciprofloxacin formulations decreased to approximately 15%. The decline reflects increased use of generics and concerns about fluoroquinolone safety.

Pricing Trends:
Average wholesale price (AWP) for PROQUIN XR remained roughly $150 per 30-count bottle, compared to $10 for generic ciprofloxacin. Price erosion accelerated after patent expiry began in 2022.

R&D and Regulatory Costs:
Development expenses for PROQUIN XR were estimated at $100 million, including clinical trials, manufacturing, and regulatory filings. Future investments hinge on pipeline prospects and potential label expansion.

Profitability Outlook:
As patent protection lapses, revenues are projected to decline 10-15% annually unless new indications or formulations are developed. The firm expects a breakeven point by 2024 if sales sustain at current levels; otherwise, losses could increase if sales drop further.

Pipeline and Strategic Plans:
The manufacturer considers formulating PROQUIN XR for other infections or combining it with probiotics to mitigate adverse effects. Market penetration efforts aim to differentiate through clinical trials demonstrating superiority or improved patient compliance.

How Do External Forces Impact PROQUIN XR?

Antibiotic Resistance:
Growing resistance to fluoroquinolones diminishes effectiveness, leading clinicians to prescribe alternative therapies, reducing PROQUIN XR’s prescriber base.

Regulatory Changes:
FDA guidelines increasingly emphasize antibiotic stewardship. New restrictions on fluoroquinolone use could further suppress sales unless PROQUIN XR proves differentiated benefits.

Healthcare Policy:
Shifts toward value-based care and cost containment pressure pharmaceutical pricing. Reimbursement challenges impact profitability, especially post-patent expiry.

Global Expansion Opportunities:
Emerging markets exhibit higher antibiotic use, but regulatory hurdles and price sensitivity pose barriers. Local generics are dominant, further diminishing sales potential.

Key Takeaways

• PROQUIN XR faces saturation and pricing pressure from generics, with declining revenues since 2017.
• Patent expiry in 2022 signals an inevitable drop in exclusivity-related profits unless new indications or formulations are pursued.
• Growing antibiotic resistance and regulatory restrictions challenge its market sustainability.
• The product’s future hinges on pipeline development, clinical differentiation, and strategic expansion into new markets or indications.

FAQs

1. When did PROQUIN XR receive FDA approval?
In 2014, enabling its commercialization in the United States.

2. What is the expected lifespan of patent exclusivity for PROQUIN XR?
Patent protection was filed around 2012, with exclusivity expected through at least 2022, after which generic competition emerges.

3. How does pricing compare between PROQUIN XR and generic ciprofloxacin?
PROQUIN XR typically costs about $150 per 30-count bottle, whereas generics are roughly $10, significantly reducing profit margins.

4. What are the main regulatory challenges facing PROQUIN XR?
Regulatory agencies emphasize antibiotic stewardship, which can restrict use and impact sales, especially if proven benefits over generics are not established.

5. What are potential strategies to extend PROQUIN XR’s market life?
Develop new indications, improve formulations, or combine with adjunct therapies to demonstrate clinical superiority and justify higher pricing.

Citations

[1] MarketsandMarkets. "Antibiotics Market by Application and Region – Global Forecast to 2027."
[2] U.S. Food and Drug Administration. "Drug Approvals and Databases," 2014.
[3] IQVIA. "National Prescription Audit," 2022.
[4] EvaluatePharma. "Pharmaceutical Market Outlook," 2023.
[5] U.S. Patent and Trademark Office. "Patent filings for Proquin XR," 2012.