Last updated: July 29, 2025
Introduction
NDC 00591-2127 corresponds to a specific pharmaceutical product registered within the United States' National Drug Code (NDC) directory. Accurate analysis of its market dynamics and price trajectory is vital for stakeholders, including manufacturers, healthcare payers, and investors. This report consolidates current market intelligence, historical pricing trends, competitive landscape, and projected pricing forecasts based on regulatory, economic, and industry-specific factors.
Product Overview
The NDC 00591-2127 identifier corresponds to Anadrol (oxymetholone), an anabolic steroid primarily indicated for anemia and muscle wasting conditions. As a semi-synthetic androgenic hormone, Anadrol has well-established therapeutic applications but also faces regulatory constraints, including controlled substance scheduling, influencing market access and pricing.
Market Landscape
1. Therapeutic Market Scope
Anadrol is used in niche markets—mainly for rare anemias and off-label indications related to muscle degenerative diseases. The global anabolic steroid market was valued at approximately USD 1.2 billion in 2022 and is forecasted to grow at a compound annual growth rate (CAGR) of 4.2% through 2030 [1].
2. Competitive Environment
The competitive landscape includes both branded and generic formulations. While Anadrol's patent exclusivity has expired, regulatory and manufacturing barriers restrict entry, resulting in limited generic competition. The existing market consists mainly of a handful of manufacturers, which supports consistent pricing.
3. Regulatory and Legal Factors
As a Schedule III controlled substance under the DEA regulations, Anadrol’s distribution is tightly controlled. Regulatory approvals for generics and biosimilars influence pricing and market share dynamics. Pricing is additionally impacted by compliance costs and the restricted supply chain.
Current Pricing Analysis
1. Pricing Structure
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Wholesale Acquisition Cost (WAC): Based on recent market data, the WAC for Anadrol 50 mg tablets (NDC 00591-2127) averages around USD 3.50 per tablet, translating to an approximate monthly expense of USD 105 for a standard 30-day supply.
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Average Wholesale Price (AWP): Typically 20-25% higher than WAC; thus, AWP is around USD 4.00 per tablet.
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Medicaid & Medicare Reimbursement: Reimbursement rates align closely with WAC and AWP, with slight variations based on regional negotiation.
2. Price Trends
Over the past five years, Anadrol has exhibited relative price stability, with marginal fluctuations attributable to manufacturing costs, regulatory shifts, and supply chain stability. Notably, during periods of increased demand—such as the COVID-19 pandemic—some price surges were observed due to supply constraints [2].
3. Discounting and Contracting Trends
Manufacturers and pharmacy benefit managers (PBMs) negotiate significant discounts, with net prices often falling below listed WAC/AWP figures. Estimates suggest that the net price for end-users could vary between USD 2.50 to USD 3.00 per tablet.
Market Driving Factors
1. Clinical and Regulatory Developments
Ongoing clinical trials exploring off-label uses could expand therapeutic indications, potentially increasing demand. Changes in regulatory policies—such as tighter control or approval of alternative therapies—could influence market penetration and pricing.
2. Patent and Exclusivity Timeline
While Anadrol’s primary patent has expired, extension efforts or reformulations might influence market exclusivity; however, current data suggest a competitive equilibrium with limited patent-protected entrants.
3. Manufacturing and Supply Chain Dynamics
Manufacturing costs, especially for controlled substances, are rising due to regulatory compliance and security measures. Supply chain disruptions have occasionally caused price volatility, although these effects appear transient.
4. Pricing Policy and Reimbursement Trends
Healthcare policy changes towards value-based care and drug pricing transparency could impact reimbursement negotiations, pressuring prices downward.
Price Projection Outlook
1. Short-term (Next 1-2 Years)
In the near term, pricing is expected to remain steady, with minor adjustments within the current range (USD 2.50 - USD 4.00 per tablet), primarily driven by supply chain efficiencies or regulatory adjustments. The ongoing patent expiration wave for similar drugs may exert slight downward pressure as generic competition gains foothold.
2. Medium to Long-term (3-5 Years)
Projected pricing trajectories suggest a modest decline of 5-10% over five years due to increased generic market penetration and evolving reimbursement policies. Additionally, advances in biosimilars and alternative therapies for anemia could marginally reduce demand, pressure prices, or shift market share.
3. Influencing Factors
- Significant regulatory alterations (e.g., scheduling changes) could either restrict or expand supply, impacting prices inversely.
- Emergence of superior or more cost-effective therapies may further decrease Anadrol’s market share, prompting price reductions.
- Manufacturing efficiencies and international expansion could stabilize or reduce prices further.
Key Challenges and Opportunities
- Regulatory Constraints: Strict control regulations limit supply flexibility, possibly shielding prices against severe declines.
- Market Penetration of Alternatives: Newer therapies targeting anemia—like erythropoiesis-stimulating agents—pose substitution risks, impacting long-term demand.
- Potential for Price Stabilization: Limited generic competition and regulatory barriers can sustain current price levels in the short term.
Key Takeaways
- Stable Current Pricing: Anadrol (NDC 00591-2127) maintains an average price around USD 3.00-4.00 per tablet, with minor fluctuations driven by supply and regulatory factors.
- Moderate Downward Price Trend: Expect a gradual 5-10% price decline over the next five years, largely due to generics and biosimilars entering the market.
- Regulatory Impact: Policy shifts and scheduling regulations significantly influence market access, manufacturing, and pricing strategies.
- Market Positioning: Limited competition supports current pricing, but long-term market share may diminish with emerging therapies.
- Strategic Considerations: Manufacturers should monitor regulatory developments, clinical trial outcomes, and demand shifts that could influence pricing dynamics.
FAQs
Q1: What factors most influence the price of Anadrol (NDC 00591-2127)?
A: Regulatory constraints, manufacturing costs, supply chain stability, market competition—particularly from generics—and reimbursement policy changes are primary factors impacting its price.
Q2: How does the regulatory status of Anadrol affect its market and pricing?
A: As a Schedule III controlled substance, regulatory restrictions limit supply flexibility and distribution, supporting price stability and protecting against rapid price declines.
Q3: What is the outlook for generic competition on Anadrol?
A: While patents have expired, the presence of manufacturing barriers and regulatory hurdles slow the entry of generics, likely maintaining current price levels in the short term.
Q4: Are there new therapies that could impact the demand for Anadrol?
A: Yes, advancements in alternative treatments for anemia, such as erythropoietin-stimulating agents, might reduce demand over time, exerting downward pressure on prices.
Q5: What should stakeholders do to optimize their position regarding Anadrol pricing?
A: Monitor regulatory developments, clinical research, and market entry of competitors; consider strategic inventory management; and engage in negotiations early to secure favorable reimbursement rates.
References
[1] Grand View Research. (2022). Anabolic Steroids Market Size, Share & Trends Analysis.
[2] IMS Health. (2021). Pharmaceutical Pricing Trends and Market Dynamics.
