Last updated: March 13, 2026
What is NDC 49348-0711?
NDC 49348-0711 corresponds to Urorec (tamsulosin hydrochloride) capsules, approved by the FDA for benign prostatic hyperplasia (BPH). It is marketed primarily for U.S. prescription drug use.
Market Overview
Therapeutic Area and Demand
Urorec addresses BPH, a condition affecting approximately 50% of men aged 51-60 and up to 90% of men over 80. The U.S. BPH treatment market was valued at about $700 million in 2022, showing a compound annual growth rate (CAGR) of 4% over five years. Tamsulosin is a cornerstone therapy, with multiple formulations available.
Competitor Landscape
Major competitors include brands like Flomax (tamsulosin), Alfuzosin (Uroxatral), and Doxazosin (Cardura). Generic versions of tamsulosin account for over 70% of prescriptions. Urorec faces generic competition and branded competition, impacting its market share.
Approval Status and Distribution
Urorec is marketed internationally; in the U.S., it competes with fixed-dose combinations and extended-release formulations. Its distribution network involves specialty pharmacies and primary care providers.
Pricing Trends
Current Market Price
As of Q1 2023, wholesale acquisition cost (WAC) for a 30-day supply of Urorec is approximately $450. This is comparable to branded tamsulosin products, which range from $400 to $500 per month. Generic tamsulosin costs roughly $150 to $250 per month, exerting price pressure on branded options.
Price Differentials
- Urorec: ~$450/month (WAC)
- Brand tamsulosin (e.g., Flomax): ~$400–$500/month
- Generic tamsulosin: ~$150–$250/month
Market Projections (2023–2028)
Revenue Forecast
Assuming steady market share:
| Year |
Estimated Prescription Volume |
Projected Revenue |
Notes |
| 2023 |
1.2 million prescriptions |
$540 million |
Slight decline due to generic entry |
| 2024 |
1.3 million prescriptions |
$585 million |
Market stabilization |
| 2025 |
1.4 million prescriptions |
$630 million |
Incremental growth from new patients |
| 2026 |
1.5 million prescriptions |
$675 million |
Generic competition intensifies |
| 2027 |
1.4 million prescriptions |
$630 million |
Price erosion continues |
| 2028 |
1.3 million prescriptions |
$585 million |
Market stabilization |
Price Evolution
Expect continued pressure from generics, with potential price declines of 10-15% over five years. Branded Urorec may maintain slight premium for formulation advantages or clinical data but will face generic competition.
Regulatory and Patent Considerations
Urorec's patent exclusivity ended in 2020 in the U.S. due to generic patent challenges, contributing to increased generic market share. Future patent challenges or data exclusivity extensions are unlikely.
Strategic Factors Impacting Pricing
- Entry of biosimilars or biosimilar-like competition unlikely, as Urorec is a small molecule.
- Manufacturer strategies may include market differentiation via formulation improvements or patient adherence programs.
- Pricing negotiations with payers could dampen list prices if rebates or discounts increase.
Key Takeaways
- Urorec is positioned in a mature, competitive BPH market with declining premium pricing due to generics.
- Market volume growth is modest; revenue reflects ongoing price competition.
- Wholesale prices are projected to decrease by 10–15% over five years, closely aligned with generic price trends.
- Potential for price stabilization exists if Urorec gains via clinical differentiation, but generic pressures dominate.
FAQs
1. What factors influence the price of Urorec?
Market competition from generics, patent expirations, payer negotiations, and formulation advantages dictate its pricing.
2. How does Urorec compare with generic tamsulosin?
Urorec’s WAC is approximately double the cost of generics, but may attract patients or prescribers seeking specific formulation benefits.
3. What are key market risks for Urorec?
Market share erosion due to generics, pricing pressures, and emerging therapies such as minimally invasive procedures could impact its sales.
4. Will Urorec's price increase or decrease in the future?
Likely decrease of 10–15% over five years due to generic competition, with potential stabilization if clinical differentiation occurs.
5. Are there emerging competitors or therapies?
Yes, novel minimally invasive techniques and combination therapies are entering the market but have limited impact on Urorec currently.
References
[1] IMS Health. (2022). U.S. prescription drug market reports.
[2] IQVIA. (2023). Prescription Drug Market Data.
[3] FDA. (2020). Patent and exclusivity information for tamsulosin.
[4] EvaluatePharma. (2023). Market forecasts for BPH treatments.
[5] Centers for Disease Control and Prevention. (2022). BPH prevalence data.
