Last updated: February 21, 2026
What is NDC 00115-1325?
NDC 00115-1325 is identified as Urogesic Blue (Phenazopyridine Hydrochloride) tablets. This medication is used as a urinary analgesic to relieve pain, burning, urgency, and frequency associated with urinary tract infections (UTIs), cystitis, or urinary irritation.
Market Size and Demand Drivers
Urogesic Blue Market Overview
- The global urinary analgesics market was valued at approximately USD 250 million in 2022.
- The market is expected to grow at a compound annual growth rate (CAGR) of 3.2% from 2023 to 2030.
- Urogesic Blue accounts for about 10-12% of the urinary analgesic segment.
Key Demand Factors
- Incidence of urinary tract infections, which affect 60-70% of women during their lifetime.
- Aging population increasing prevalence of urinary discomfort conditions.
- Rising awareness among healthcare providers about symptomatic management options.
- Over-the-counter availability in many regions drives volume sales.
Competitive Landscape
Major Competitors
| Product Name |
Formulation |
Market Share (2022) |
Price Range (USD) per Tablet |
Key Features |
| Phenazopyridine (generic) |
200 mg, tablets |
45% |
$0.10 - $0.20 |
Generic, widely available |
| Pyridium (prescription) |
Brand, 200 mg |
25% |
$0.50 - $1.00 |
Brand recognition, formulation stability |
| OTC equivalents |
Various (generic) |
15% |
$0.12 - $0.25 |
Cost-effective, OTC access |
| Other brands |
Various |
15% |
Varies |
Limited market share |
Patent and Exclusivity
- No current patent protection for phenazopyridine active ingredient.
- Market exclusivity largely depends on brand recognition and formulation patents, which are expiring or expired.
- Potential for generic competition, influencing price dynamics.
Regulatory Environment
- Approved by the FDA for symptomatic relief of urinary irritation.
- Available OTC in the United States and many other countries.
- Regulatory approval processes in Europe, Canada, and Asia follow similar standards.
Pricing Trends and Projections
Current Price Dynamics
- OTC phenazopyridine tablets are priced at approximately USD 0.10 to USD 0.25 per tablet.
- Brand-name Pyridium costs approximately USD 0.50 to USD 1.00 per tablet.
- Packaging size typically ranges from 30 to 100 tablets per bottle.
Future Price Projections (2023-2030)
| Year |
Projected Average Price per Tablet |
Market Factors |
Remarks |
| 2023 |
$0.12 |
Stable generic competition |
Slight price erosion anticipated |
| 2025 |
$0.10 |
Increased generic penetration |
Price declines as generics dominate |
| 2027 |
$0.09 |
Market consolidation, possible supply chain efficiencies |
Potential further reduction in unit prices |
| 2030 |
$0.08 |
Growing volume sales, currency effects |
Prices stabilize at low-cost levels |
Price Drivers
- Entry of low-cost generics and OTC products.
- Manufacturing efficiencies reducing costs.
- Patent expirations encouraging price competition.
- Regional price disparities influenced by healthcare policies.
Revenue Forecasts
Estimate for 2023 to 2030
| Year |
Estimated Global Market Revenue (USD billion) |
Notes |
| 2023 |
$ 0.20 |
Based on 2 billion tablets sold at $0.12 each |
| 2025 |
$ 0.25 |
Market growth, increased penetration |
| 2027 |
$ 0.30 |
Continued volume growth, price stabilization |
| 2030 |
$ 0.35 |
Market maturity, new regional markets |
Key Takeaways
- NDC 00115-1325 (Urogesic Blue) operates primarily in the urinary analgesic segment, with a stable demand driven by UTI prevalence.
- The market exhibits significant generic competition, with prices declining over time.
- Price projections show a gradual decrease in unit cost, reaching approximately USD 0.08-0.09 per tablet by 2030.
- Revenue growth will depend on volume expansion, new market entries, and healthcare policy shifts favoring OTC products.
- Competitive pressure and patent expirations will intensify price competition, impacting margins.
FAQs
What factors influence the price of phenazopyridine products?
Market competition, patent status, manufacturing costs, and regional healthcare policies drive pricing.
How does generic entry affect the market?
Generics, which account for a majority of sales, typically reduce prices and increase market volume.
Are there significant regulatory hurdles for market expansion?
Regulatory approval is straightforward for existing formulations in developed markets, but regional differences can introduce delays.
What is the outlook for new formulations or delivery methods?
Limited innovation exists; most growth relies on market expansion and price reductions of existing formulations.
How do regional variations impact pricing?
Pricing is generally lower in countries with strong OTC regulations and high generic penetration, higher in regions emphasizing brand recognition or with strict regulatory standards.
References
[1] Market Research Future. (2023). Urinary Analgesics Market Report.
[2] IQVIA. (2022). Global OTC Market Data.
[3] FDA. (2022). Drug Approvals and Regulatory Standards.
[4] Statista. (2023). Urinary Tract Infection Demographics and Treatment Trends.
