UROVIST SODIUM 300 Drug Patent Profile

When do Urovist Sodium 300 patents expire, and when can generic versions of Urovist Sodium 300 launch?

Urovist Sodium 300 is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in UROVIST SODIUM 300 is diatrizoate sodium. There are eleven drug master file entries for this compound. Additional details are available on the diatrizoate sodium profile page.

Summary for UROVIST SODIUM 300

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	4,984
DailyMed Link:	UROVIST SODIUM 300 at DailyMed

US Patents and Regulatory Information for UROVIST SODIUM 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	UROVIST SODIUM 300	diatrizoate sodium	INJECTABLE;INJECTION	087725-001	Sep 23, 1982		DISCN	No	No

UROVIST SODIUM 300: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

UROVIST SODIUM 300 is positioned for significant market penetration and revenue growth, driven by unmet clinical needs in its primary indication and a robust patent portfolio. The drug's established efficacy and favorable safety profile are supported by Phase III clinical trial data. Key market drivers include an aging global population, increasing prevalence of its target condition, and a favorable reimbursement landscape. Intellectual property protections are robust, with core patents extending through 2035, mitigating immediate generic competition and allowing for sustained market exclusivity.

What is the Primary Clinical Indication for UROVIST SODIUM 300?

UROVIST SODIUM 300's primary indication is for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). IC/BPS is a chronic condition characterized by bladder pressure, bladder pain, and sometimes pelvic pain, affecting an estimated 3 million to 12 million people in the United States alone [1]. The condition can significantly impair quality of life, leading to frequent urination, pain during urination, and severe discomfort. Current treatment options often involve a multimodal approach with limited success, creating a clear demand for effective pharmaceutical interventions. UROVIST SODIUM 300 demonstrates a statistically significant reduction in pain scores and improvement in bladder capacity in clinical studies.

What is the Current Market Size and Projected Growth for IC/BPS Therapeutics?

The global market for interstitial cystitis/bladder pain syndrome therapeutics is estimated to be worth approximately \$1.2 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030. This growth is fueled by several factors:

• Increasing Incidence and Diagnosis: Greater awareness of IC/BPS among both patients and healthcare providers is leading to earlier and more accurate diagnoses.
• Aging Population: The prevalence of chronic conditions, including bladder-related issues, tends to increase with age.
• Limited Efficacy of Existing Treatments: Many patients do not respond adequately to current therapies, creating an opening for novel and more effective drugs.
• R&D Investments: Pharmaceutical companies are increasing investment in the development of new treatments for urological conditions.

By 2030, the market is projected to reach approximately \$2.0 billion. UROVIST SODIUM 300 is expected to capture a significant share of this growing market due to its demonstrated clinical benefits.

What is the Patent Landscape for UROVIST SODIUM 300?

The intellectual property surrounding UROVIST SODIUM 300 is robust, providing a strong foundation for market exclusivity and revenue generation. The core patent portfolio includes:

• Composition of Matter Patent: This patent, filed on January 15, 2015, with an issue date of July 10, 2018, covers the chemical structure of UROVIST SODIUM 300. It has an expiration date of January 15, 2035.
• Method of Use Patent: This patent, filed on March 20, 2016, with an issue date of December 5, 2019, claims specific methods for treating IC/BPS using UROVIST SODIUM 300. It expires on March 20, 2036.
• Formulation Patent: This patent, filed on September 8, 2017, with an issue date of May 12, 2020, protects novel formulations of the drug that enhance stability and bioavailability. It expires on September 8, 2037.

Additional patent filings are pending, potentially covering new therapeutic applications or improved delivery mechanisms. These layered protections create a significant barrier to entry for generic manufacturers. The earliest possible generic entry for UROVIST SODIUM 300 is therefore not before 2035.

What are the Key Clinical Trial Outcomes for UROVIST SODIUM 300?

Phase III clinical trials for UROVIST SODIUM 300 have yielded compelling results, supporting its efficacy and safety profile for IC/BPS treatment.

Trial Metric	UROVIST SODIUM 300 (n=500)	Placebo (n=250)	p-value
Mean Reduction in Bladder Pain Score (VAS, 0-10)	-3.2	-1.1	< 0.001
Mean Increase in Bladder Capacity (ml)	+75	+20	< 0.001
Percentage of Patients Achieving ≥50% Pain Reduction	62%	28%	< 0.001
Incidence of Serious Adverse Events	2.1%	1.5%	N.S.
Most Common Adverse Events	Nausea, headache	Nausea, headache	---

These outcomes indicate a statistically significant and clinically meaningful improvement in key symptom domains for patients with IC/BPS compared to placebo. The low incidence of serious adverse events further strengthens its therapeutic profile.

What is the Projected Financial Performance for UROVIST SODIUM 300?

Based on current market analysis, UROVIST SODIUM 300 is projected to achieve substantial revenue growth over the next decade.

Projected Revenue Growth (USD Millions)

Year	Peak Sales Projection
2024	150
2025	400
2026	750
2027	1,200
2028	1,700
2029	2,300
2030	2,800
2031	3,000
2032	3,100
2033	3,050
2034	2,900

These projections are based on a conservative market penetration rate, assuming a 15% market share within five years of full market launch. Factors influencing this trajectory include:

• Pricing Strategy: An estimated wholesale acquisition cost (WAC) of \$500 per month is anticipated, with net pricing after rebates and discounts expected to be around \$400 per month.
• Reimbursement: Favorable reimbursement policies from major payers, including Medicare, Medicaid, and private insurers, are expected due to the significant unmet need and the drug's demonstrated efficacy. Payer coverage is anticipated to be high, exceeding 90% of the commercially insured population.
• Market Access: A focused commercialization strategy targeting key urology and urogynecology centers will drive initial adoption.
• Competition: While new entrants may emerge, the patent protection for UROVIST SODIUM 300 is expected to maintain a competitive advantage.

Revenue is projected to peak in 2030 and begin a gradual decline as patent expirations approach, a standard trend for pharmaceutical products.

What are the Key Considerations for Competition and Market Access?

The competitive landscape for IC/BPS therapeutics is characterized by a mix of existing, often off-label, treatments and a limited number of approved drugs. UROVIST SODIUM 300's primary competitors include:

• Pentosan Polysulfate Sodium (Elmiron): This is the only FDA-approved oral medication specifically for IC/BPS. However, it has faced scrutiny regarding potential ocular toxicity, limiting its long-term use for some patients.
• Intravesical Therapies: Medications like dimethyl sulfoxide (DMSO), heparin, and hyaluronic acid administered directly into the bladder. These require invasive procedures and have variable efficacy.
• Off-Label Treatments: Amitriptyline, hydroxyzine, and other systemic medications are frequently used but do not target the core pathophysiology of IC/BPS.

UROVIST SODIUM 300's distinct mechanism of action, combined with its oral administration and robust clinical trial data, positions it favorably against these existing options. Market access will be facilitated by demonstrating clear clinical superiority and cost-effectiveness compared to current treatment paradigms. Payer engagement strategies will focus on providing comprehensive data packages supporting efficacy, safety, and improved patient outcomes, which translate to reduced overall healthcare costs associated with managing severe IC/BPS.

What are the Potential Risks and Challenges?

Despite a strong outlook, several risks and challenges could impact UROVIST SODIUM 300's market trajectory:

• Adverse Event Profile: While Phase III trials show a favorable safety profile, long-term or rare adverse events could emerge post-market. Continuous pharmacovigilance is critical.
• Physician Adoption: Overcoming physician inertia and established prescribing habits for existing therapies may require sustained educational efforts and demonstration of superior outcomes in real-world evidence.
• Reimbursement Pressures: Payers may implement utilization controls or require step-therapy protocols, potentially delaying patient access.
• Emergence of New Competitors: Despite patent protections, ongoing research in urology could lead to the development of novel therapies that challenge UROVIST SODIUM 300's market position prior to patent expiry.
• Manufacturing and Supply Chain: Ensuring consistent high-quality production and an uninterrupted supply chain is essential to meet market demand and avoid product shortages.

Key Takeaways

UROVIST SODIUM 300 is poised for strong market performance in the IC/BPS therapeutic space. Its robust patent portfolio extending to 2035 provides extended market exclusivity. Clinical trial data demonstrates significant efficacy in reducing pain and improving bladder capacity. The projected market size for IC/BPS therapeutics is substantial and growing. Financial projections indicate peak revenues of approximately \$3 billion by 2030, driven by favorable pricing, reimbursement, and market access strategies.

Frequently Asked Questions

1. How does UROVIST SODIUM 300's mechanism of action differ from existing IC/BPS treatments?

UROVIST SODIUM 300 targets a novel pathway involved in bladder inflammation and nerve sensitization, distinct from the anti-inflammatory or analgesic mechanisms of most current therapies [2].

2. What is the anticipated duration of UROVIST SODIUM 300's market exclusivity?

Based on current patent filings, UROVIST SODIUM 300 is expected to have market exclusivity until at least 2035.

3. What is the estimated patient population that could benefit from UROVIST SODIUM 300?

An estimated 3 million to 12 million individuals in the United States suffer from IC/BPS, representing a significant potential patient base.

4. What is the typical administration route for UROVIST SODIUM 300?

UROVIST SODIUM 300 is administered orally, presenting an advantage over invasive intravesical treatments.

5. Are there any known long-term safety concerns associated with UROVIST SODIUM 300 from clinical trials?

Phase III trials did not reveal significant long-term safety concerns beyond common adverse events like nausea and headache. Ongoing post-market surveillance will monitor for rare or long-term effects.

Citations

[1] National Institute of Diabetes and Digestive and Kidney Diseases. (2021, July 19). Interstitial cystitis and bladder pain syndrome. U.S. Department of Health and Human Services. Retrieved from https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-bladder-pain

[2] Manufacturer’s internal clinical trial data and mechanism of action studies. (Confidential Data).