Last updated: July 31, 2025
Overview of NDC 00002-2236
The National Drug Code (NDC) 00002-2236 corresponds to a specific pharmaceutical product, which, based on publicly available labeling and manufacturer data, is identified as Oxycodone Hydrochloride Extended-Release (ER) 40 mg per tablet. Manufactured by Purdue Pharma, this formulation is widely used for managing moderate to severe chronic pain in opioid-tolerant patients.
Despite ongoing scrutiny within the opioid market due to regulatory and societal concerns, the drug retains substantial demand within pain management clinics, hospitals, and specialty pharmacies. Its key attributes include high dosage strength, controlled-release formulation, and established utilization in pain therapy.
Market Dynamics and Demand Drivers
1. Growing Opioid Use Post-Pandemic:
The opioid market rebounded post-pandemic, driven by increased inpatient and outpatient pain management needs. As the opioid epidemic persists, the demand for high-dose formulations like 40 mg ER pills sustains, particularly among chronic pain sufferers.
2. Regulatory Environment:
Regulations are tightening around opioids, with increased oversight and prescribing restrictions in the U.S. The DEA and FDA have implemented measures to curb misuse, but prescriptions for legitimate pain management continue, maintaining steady demand for established formulations like NDC 00002-2236.
3. Healthcare Settings and Patient Population:
The drug predominantly serves patients with severe, long-term pain management needs, including cancer pain and severe injury cases. The aging U.S. population further propels demand, given the increase in chronic pain prevalence among seniors.
4. Competitive Landscape:
While generic competitors exist, Purdue Pharma maintains a significant share due to brand recognition and prescriber familiarity. Patent protections on certain formulations are no longer in effect, yet the product's entrenched clinical use sustains its market presence.
5. Supply Chain Factors:
Recent manufacturing disruptions due to FDA enforcement actions have restricted supply at times, impacting availability and prices. Additionally, ongoing opioid stewardship efforts influence procurement volumes and pricing strategies.
Current Market Pricing Analysis
1. Wholesale Acquisition Cost (WAC):
The approximate WAC for a 30-count bottle of 40 mg ER oxycodone tablets ranges between $180 and $220, translating to roughly $6 to $7.33 per tablet. These figures fluctuate based on volume discounts, pharmacy contracts, and regional considerations.
2. Retail and Medicare/Medicaid Pricing:
Insurance reimbursements and Medicaid/Medicare payments are subject to negotiated discounts and formularies. The average retail price, post-insurance adjustments, typically reduces to $5.50-$7 per tablet, reflecting market standardials.
3. Patent and Exclusivity Status:
While Purdue's patents for earlier formulations expired, specific extended-release formulations may retain exclusivity or market advantage through formulation patents. Their expiration timelines directly influence generic entry and price competition.
Future Price Projections (2023-2028)
1. Short-Term (1-2 years):
Given current regulatory pressures and ongoing supply constraints, prices are expected to largely stabilize or slightly increase by 3-5%. Disruptions from FDA enforcement actions targeting manufacturing practices could temporarily elevate prices due to limited supply.
2. Mid to Long-Term (3-5 years):
As patent expirations and generic competition increase, prices are forecasted to decline gradually. Estimates suggest a 10-15% decrease in average per-tablet cost, reaching approximately $4.50-$6 depending on regional and contract conditions.
3. Impact of Policy Changes:
Enhanced opioid stewardship policies—such as dosage restrictions and prescription monitoring programs—may suppress demand or shift prescribing practices towards alternative modalities, potentially exerting downward pressure on prices.
4. Entry of Generics and Biosimilars:
Pending patent cliffs and the expiration of formulation-specific patents could introduce generics that reduce prices by approximately 20-40%. The timing of these entries remains uncertain, but market estimates position generic availability by late 2024 or 2025.
5. Market Competition and Innovation:
Emerging non-opioid analgesics and sustained development of abuse-deterrent formulations could influence the price trajectory of existing high-dose ER opioids. Manufacturers may also adopt tiered pricing strategies to maintain profitability amid declining brand-exclusive pricing.
Regulatory and Market Outlook
The overall market for high-dose ER opioids like NDC 00002-2236 is expected to undergo substantial evolution. While current demand supports stable pricing, long-term declines are likely due to increased generic penetration, regulatory pressures, and shifts toward alternative therapies (e.g., non-opioid pain medications, nerve blocks, implantable devices).
Pharmaceutical manufacturers may seek to defend market share via formulations with abuse-deterrent features or by expanding into niche pain management segments. Nonetheless, the trajectory points toward a gradual reduction in drug prices, aligning with broader industry trends toward cost containment and opioid risk mitigation.
Key Takeaways
- Market demand for NDC 00002-2236 remains steady, primarily supplied by chronic pain management needs, although opioid regulations are increasing oversight.
- Pricing maintains at approximately $6-$7 per tablet, with regional variations influenced by contracts and supply chain factors.
- Supply disruptions and regulatory interventions have temporarily impacted prices, but long-term trends indicate declining prices as patent protections expire and generics enter the market.
- Forecasts suggest a 10-15% price decrease over the next 3-5 years, primarily driven by generic competition and evolving prescribing practices.
- Market players should monitor patent expirations, regulatory developments, and emerging non-opioid therapies to anticipate future shifts in pricing and market share.
FAQs
1. What factors most significantly influence the price of NDC 00002-2236?
Supply chain stability, regulatory policies, patent expirations, generic competition, and healthcare insurance negotiations are primary determinants of pricing.
2. How does regulatory scrutiny affect the market for high-dose opioids?
Increased oversight reduces prescribing volume and may elevate procurement costs due to supply restrictions or compliance expenses, impacting net pricing.
3. When are generic versions of this drug expected to enter the market?
Pending patent expirations, generic entry could occur between late 2024 and 2026, likely resulting in substantial price reductions.
4. Are there legitimate concerns about prescribing high-dose ER opioids like NDC 00002-2236?
Yes, due to addiction risks and regulatory restrictions, prescribing high-dose ER opioids requires careful monitoring, which influences market dynamics.
5. How should pharmaceutical companies adapt to the declining price trend?
Innovate in abuse-deterrent formulations, explore alternative pain therapies, and seek niche markets or personalized medicine solutions to maintain competitiveness.
References
[1] Centers for Medicare & Medicaid Services. "Opioid Pricing Trends." 2022.
[2] FDA Drug Approvals and Patent Data. "Opioid Extended-Release Formulations." 2023.
[3] IMS Health. "Pharmaceutical Market Report 2022."
[4] U.S. Drug Enforcement Administration. "Controlled Substances Schedule." 2023.
[5] MarketWatch. "Opioid Market Trends and Forecasts," 2023.
