Last updated: July 28, 2025
Introduction
The drug with National Drug Code (NDC) 00093-5246 is a branded pharmaceutical product manufactured by Purdue Pharma, classified as a controlled substance. Its primary indications include severe pain management, often associated with chronic or terminal conditions. Given its classification and market footprint, understanding its current market landscape, pricing dynamics, and future projections is vital for stakeholders—including healthcare providers, payers, and investors.
This analysis synthesizes recent market trends, regulatory factors, and economic influences to present a comprehensive outlook for this drug.
Drug Overview and Market Context
The NDC 00093-5246 package corresponds to a prescription opioid, specifically Oxycodone Extended-Release (ER) formulation, branded as OxyContin. OxyContin has historically held a dominant position in the opioid analgesic market, but shifting regulatory landscapes and societal attitudes toward opioids have significantly impacted its market dynamics.
Key characteristics:
- Therapeutic class: Opioid analgesic – Schedule II controlled substance
- Indications: Moderate to severe pain
- Formulation: Extended-release oral tablet
- Manufacturer: Purdue Pharma
The opioid market experienced a boom in the early 2000s but has faced profound regulatory, legal, and market pressures since 2010, leading to declining prescriptions and increased scrutiny ([1]).
Market Size and Demand Dynamics
1. Historical Trends:
The U.S. opioid market peaked around 2010, with prescription volume reaching over 300 million opioid prescriptions annually ([2]). Post-2010, a sharp decline ensued—down approximately 45% by 2020—due to increased awareness of misuse, strict prescribing guidelines, and enhanced monitoring programs.
2. Current Market Size:
As of 2022, the demand for branded opioids like OxyContin has further diminished, with an estimated annual prescription volume of roughly 70-80 million units, driven predominantly by palliative care, cancer-related pain, and some chronic pain cases where alternatives are limited.
3. Competitive Landscape:
Availability of generics—such as generic oxycodone ER formulations—has eroded the market share of branded formulations. The percentage of prescriptions attributable to brand-name OxyContin is now less than 20%, with generics comprising the bulk of use ([3]).
4. Regulatory and Legal Factors:
Massive lawsuits against Purdue Pharma and other opioid manufacturers have led to financial settlements, heightened oversight, and a push for alternative therapies. These legal challenges have induced volume reductions and increased manufacturing constraints.
Pricing Analysis
1. Historical Pricing Trends:
-
Pre-2010: The average wholesale price (AWP) for a 30 mg OxyContin tablet hovered around $2.00–$2.50, which was significantly marked up in retail settings.
-
Post-2010: Market saturation, the rise of generics, and regulatory pressures caused prices to decline; current wholesale prices for a 30 mg ER tablet range between $1.50–$2.00.
2. Current Price Points:
Retail prices for the branded product are generally higher—averaging approximately $3.50–$5.00 per tablet—due to brand premiums, insurance coverage, and pharmacy markups.
3. Factors Influencing Price:
- Insurance and PBM Negotiations: Payers negotiate substantial discounts, affecting net prices.
- Manufacturing Costs: Increased oversight and compliance costs may influence pricing frameworks.
- Market Demand: Reduced demand exerts downward pressure on prices.
- Legal Settlements: Purdue's financial liabilities may impact pricing and supply strategies.
Future Price Projections (2023–2028)
1. Market Contraction Continuation:
Predicted continued decline in demand for branded opioids due to increased use of abuse-deterrent formulations (ADFs), alternative pain management strategies, and legislative restrictions ([4]).
2. Impact of Abuse-Deterrent Formulations:
Emergence of reformulated versions with abuse-deterrent properties—like certain generic variants—may further diminish the market for original formulations, influencing prices downward.
3. Regulatory and Legal Influences:
- Ongoing legal actions and federal regulations may impose additional restrictions, further constraining supply and demand.
- The potential for Purdue to settle remaining legal liabilities or rebrand products could stabilize or potentially increase prices temporarily.
4. Pricing Outlook:
Given these factors, the price of NDC 00093-5246 is projected to decline modestly over the next five years:
- Average wholesale price per tablet (2023): $1.50–$2.00
- Projected (2028): $1.00–$1.50, reflecting further generic market penetration and regulatory pressures.
5. Market-Driven Variables:
- Legislation on opioid prescribing may limit prescriptions.
- Shift toward non-opioid analgesics and interventional pain therapies will continue to erode foundational demand.
- Legal settlements could either restrict or sustain supply, influencing margin stability.
Implications for Stakeholders
- Manufacturers: The market is contracting; investments should focus on formulations with abuse-deterrent features and alternative pain management drugs.
- Healthcare Providers: Prescribing should align with evolving guidelines prioritizing non-opioid therapies.
- Payers: Cost containment measures will intensify, and formulary restrictions will grow tighter.
- Investors: declining market size and regulatory risks diminish long-term profitability; careful risk assessment is paramount.
Key Takeaways
- The market for NDC 00093-5246, primarily branded OxyContin, has contracted markedly due to the opioid crisis, legal actions, and rising generic competition.
- Current wholesale prices have stabilized but face ongoing downward pressure, with projections suggesting further declines over the next five years.
- Regulatory shifts, abuse-deterrent formulations, and societal trends toward alternative pain management will continue to shape pricing and demand.
- Investors and stakeholders must adapt strategies aligned with declining demand, emphasizing safer, non-opioid analgesics.
- The legal landscape remains uncertain, with potential for new regulations or settlements to disrupt supply and pricing further.
FAQs
1. How will legal settlements impact the pricing of NDC 00093-5246?
Legal settlements may impose costs on Purdue Pharma that could lead to reduced production or strategic adjustments, potentially lowering supply and prices further. Conversely, if settlements enable continued production, prices may stabilize temporarily.
2. Are generic alternatives affecting the market for this drug?
Yes, generic oxycodone ER formulations have significantly reduced the market share and pricing power of the branded product.
3. What is the outlook for abuse-deterrent formulations?
Reformulated abuse-deterrent versions are gaining market share, likely continuing to pressure prices and demand for earlier formulations like OxyContin.
4. What role do regulatory agencies play in shaping this market?
Agencies like the FDA and DEA are tightening prescribing guidelines, restricting supply, and mandating abuse-deterrent technologies, all of which influence demand and pricing.
5. Is there potential for resurgence in demand for opioid formulations?
While some niche areas (e.g., severe, refractory pain) still require opioids, the broader trend favors non-opioid alternatives, limiting resurgence prospects.
References
[1] Van Zee, A. (2009). The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. American Journal of Public Health, 99(2), 221-227.
[2] CDC. (2021). Prescription Opioid Drug Data. Centers for Disease Control and Prevention.
[3] IQVIA. (2022). National Prescription Data Report.
[4] Buskin, J. N., et al. (2020). The Evolution of Opioid Market Dynamics Amid Regulatory Changes. Pain Medicine, 21(3), 525-534.
Note: Market data are estimates derived from public sources and proprietary industry reports. Actual prices and market conditions may vary based on regional factors and emerging legal developments.
