Last updated: March 10, 2026
What Is NDC 00093-9149?
NDC 00093-9149 is an analog of methadone, marketed as Methadone Hydrochloride Oral Solution. It is used primarily for opioid dependency and pain management. Typically, this NDC corresponds to a formulation supplied by commercial manufacturers such as Purdue Pharma or equivalent, with specifications matching those of controlled-release dextroamphetamine or methadone formulations.
Market Context and Current Landscape
Market Overview
The drug market for controlled opioids, including methadone, has seen fluctuations driven by regulatory pressures, addiction management needs, and generic entry.
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Global demand: The opioid treatment market was valued at approximately USD 1.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2028 [1].
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US Market: The United States accounts for nearly 60% of global opioid sales, driven by addiction treatment, pain management, and substitution therapies.
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Regulatory environment: The Drug Enforcement Administration (DEA) tightly controls methadone distribution under federal schedules. Recent policies have focused on reducing misuse while expanding access for legitimate treatment [2].
Competition and Generic Penetration
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Existing formulations: Multiple manufacturers produce generic methadone products. The market is moderately consolidated, with a few dominant players controlling approximately 70% of sales.
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Pricing strategies: Generics typically retail at 15-30% below branded formulations. Price competition has intensified, leading to a decrease in wholesale acquisition costs (WAC).
Patent and Regulatory Status
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The primary patents for methadone formulations have expired. However, formulations with specific delivery systems can still be protected under new patents or data exclusivity.
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The referenced NDC is a generic product, with no active patent protections, facilitating market entry.
Price Projections
Current Pricing Metrics
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Average wholesale price (AWP): USD 2.55 per mL for 10mg/mL oral solutions [3].
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Reimbursement rates: Medicaid and Medicare reimbursements hover around USD 2.00–2.50 per mL, depending on state adjustments.
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Market price trends: Over the last 3 years, wholesale prices have decreased approximately 5% annually, reflecting increased generic supply and regulatory controls.
Short-Term Outlook (Next 1-2 Years)
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Prices are expected to stabilize or decline slightly, averaging USD 2.25–2.45 per mL due to continued generic competition and price pressures.
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The growth in demand for opioid dependency treatments could sustain revenue levels even amid declining prices.
Long-Term Projections (3-5 Years)
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Given regulatory constraints, price erosion may plateau, with anticipations of slight increases driven by inflation, increased production costs, or supply chain disruptions (e.g., pandemic-related factors).
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Estimated price range: USD 2.20–2.40 per mL.
Market Opportunities and Risks
Opportunities
Risks
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Regulatory crackdowns limiting supply or increasing compliance costs.
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Market saturation with generics diminishing profit margins.
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Pricing pressures due to healthcare reimbursement reforms and market consolidations.
Key Takeaways
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The market for NDC 00093-9149 remains sizable within opioid dependence treatment, with gradual price declines driven by generic competition.
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The compound's approval status and patent landscape facilitate multiple manufacturers, stabilizing supply but increasing price competition.
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Short-term prices will likely hover around USD 2.25–2.45 per mL, with minimal volatility.
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Long-term, slight price increases may occur due to inflation and supply chain factors, but aggressive price hikes are unlikely absent patent protections or formulation innovation.
FAQs
What is the primary use of NDC 00093-9149?
It is used for opioid dependence treatment and pain management as an oral methadone solution.
How does the market for methadone market look globally?
It is growing at a CAGR of approximately 4.2%, driven mainly by the US demand for addiction treatment.
What factors influence the pricing of this drug?
Generic competition, regulatory policies, supply chain costs, and reimbursement policies.
Are there patent protections that could influence pricing?
Current formulations are typically off patent, allowing multiple manufacturers to compete on price.
What are the main risks to market stability?
Regulatory restrictions, market saturation, and reimbursement reforms could pressure prices further.
References
[1] Grand View Research. (2022). Opioid Market Size, Share & Trends Analysis Report.
[2] U.S. Drug Enforcement Administration. (2022). 2022 Drug Scheduling Overview.
[3] Red Book. (2023). Pharmaceutical Pricing and Cost Data.
