Last updated: September 7, 2025
Introduction
The pharmaceutical landscape is dynamic, heavily influenced by regulatory changes, patent status, market competition, and innovative therapies. The drug with NDC 00093-5504, classified in the National Drug Code (NDC) system, warrants a focused analytical overview for stakeholders aiming to understand its current market positioning and future pricing trajectory. This analysis synthesizes data from regulatory filings, industry reports, and pricing trends to elucidate opportunities and risks aligned with this specific drug.
Drug Profile and Regulatory Status
The NDC 00093-5504 is identified as Probenecid, a longstanding uricosuric agent primarily indicated for gout and hyperuricemia management. Its pharmacological profile has remained relatively consistent over decades but has seen emerging interest as an adjunct in antimicrobial therapies and potential repurposing for other indications.
Probenecid was first approved by the FDA in 1960, and its patent expiration has led to a proliferation of generic formulations, impacting price points and market competition. Current formulations include oral tablets, characterized by stable manufacturing processes and widespread availability.
Market Overview
Therapeutic Area Dynamics
Probenecid falls within the gout and uric acid-lowering agents market, which has witnessed evolving management guidelines favoring newer biologics and urate oxidase agents, especially for refractory cases. However, due to its affordability and long history, Probenecid remains a first-line or adjunct therapy in many settings, especially in markets prioritizing cost containment.
Market Size & Consumption
Globally, the gout drug market is projected to reach $1.5 billion by 2025, with Probenecid representing approximately 15-20% of this segment in the U.S., driven by generic availability and established prescribing patterns. The volume of prescriptions has stabilized but may face erosion from newer treatment modalities and changing clinical guidelines focusing on uric acid reduction targets.
Pricing Landscape
Since the patent expiry, the drug's price has experienced significant declines. In the U.S., generic Probenecid prices per tablet range from $0.05 to $0.15, depending on manufacturer and pharmacy networks. Retail prices for a typical month’s supply (~30 tablets) are generally in the $1.50 to $4.50 range, emphasizing its role as a low-cost generic medication.
In contrast, markets with limited generic penetration or different regulatory frameworks may see higher prices. For instance, in certain European countries, branded formulations may command prices upwards of $15 per tablet.
Competitive Market Analysis
Generic Competition
The fierce competition among generic manufacturers has led to substantial price compression. Major pharmaceutical companies and compounding pharmacies produce Probenecid, with no recent patent protections, further intensifying price competition.
Emerging Therapies and Repositioning
While traditional forms remain dominant, research into alternative uricosuric agents and novel biologics (e.g., anti-IL-1 agents, urate transport inhibitors) pose substitutes potentially impacting future demand.
Additionally, Probenecid's role as an antiviral agent (notably for COVID-19 research) offers a speculative upside, though clinical validation remains ongoing.
Reimbursement and Market Access
Government reimbursement programs, such as Medicare and Medicaid in the U.S., tend to favor low-cost generics, bolstering volume but constraining margins. Private insurers may negotiate discounts, further influencing effective pricing.
Price Projection Insights
Short-term Outlook (1-2 Years)
Over the next year, the market for Probenecid is expected to remain stable with minimal price fluctuations, driven by mature generic competition and steady demand. Regulatory efforts, such as potential policy-driven price ceilings or importation policies, could marginally influence prices.
Medium-term Outlook (3-5 Years)
Potential shifts include:
- Market Saturation: Continued generic competition will sustain low price levels.
- Regulatory Changes: Implementation of price controls or increased formulary restrictions could suppress prices further.
- Repositioning & New Uses: Investigations into alternative indications, such as antiviral therapies, may temporarily boost demand, potentially impacting prices if new formulations or delivery systems emerge.
Long-term Outlook (5+ Years)
The price sustainability hinges on:
- Patent and exclusivity landscapes: Already expired, thus fostering ongoing generic proliferation.
- Emerging therapies: The advent of more effective or targeted treatments may supplant Probenecid in specific indications.
- Manufacturing costs: Low due to mature chemistry and manufacturing, constraining upward price movements.
In conclusion, Probenecid (NDC 00093-5504) is poised to retain a low-cost status dominated by generics, with a stable but limited upward price trajectory barring significant regulatory or clinical paradigm shifts.
Key Market Drivers & Risks
| Drivers |
Risks |
| Established efficacy & low-cost generics |
Market saturation & price erosion |
| Growing prevalence of gout |
Competition from newer therapeutics |
| Favorable reimbursement policies for generics |
Regulatory suppression of prices |
| Ongoing research into novel indications |
Off-label use impacting demand unpredictably |
Conclusions
The primary market for NDC 00093-5504 (Probenecid) remains robust within its prescribed indications, predominantly driven by generic manufacturing efficiencies and cost-sensitive healthcare environments. Price projections indicate a continued low-price trajectory with minimal volatility, contingent on maintaining current operational and competitive dynamics. Stakeholders should monitor regulatory developments and emerging therapies that could influence future demand and pricing strategies.
Key Takeaways
- Market Position: Probenecid retains a stable, low-cost position due to its patent expiry, extensive generic availability, and longstanding clinical use.
- Price Trend: Expect minimal short-term price increases; long-term stability likely barring disruptive innovations or regulatory interventions.
- Competitive Landscape: Intense generic competition keeps prices under pressure but sustains widespread accessibility.
- Emerging Factors: Research into new indications or alternative therapies could temporarily influence demand but are unlikely to disrupt existing low-price benchmarks.
- Strategic Focus: Stakeholders should focus on optimizing supply chain efficiencies and monitoring regulatory policies shaping generic drug pricing.
FAQs
1. How does patent expiration impact the pricing of NDC 00093-5504?
Patent expiry allows multiple manufacturers to produce generic versions, significantly lowering prices due to increased competition and reduced licensing barriers.
2. Are there significant regional variations in Probenecid pricing?
Yes. While U.S. prices are generally low for generics, countries with limited generic penetration or different regulatory regimes can see higher prices, sometimes exceeding $15 per tablet.
3. What factors could cause a shift in the market demand for Probenecid?
Emerging clinical guidelines favoring newer urate-lowering therapies, development of alternative medications, or successful repurposing for new indications could diminish or augment demand.
4. Will regulatory policies likely influence the future price of this drug?
Price caps, import restrictions, or enhanced reimbursement controls aimed at reducing drug costs could further suppress prices but are less probable without significant policy shifts.
5. How should manufacturers strategize for sustained profitability in this market?
Focusing on manufacturing efficiencies, expanding indications through clinical trials, and engaging in market access negotiations are essential for maintaining margins amid stiff generic competition.
Sources:
[1] IQVIA, "The Global Use of Medicines," 2022.
[2] FDA Drug Approvals and Labeling, 2022.
[3] EvaluatePharma, "Gout Market Analysis," 2022.
[4] U.S. Medicaid Pricing Reports, 2022.
