Last updated: March 12, 2026
What is NDC 00065-9240?
NDC 00065-9240 corresponds to Oxycodone Hydrochloride Extended-Release (brand names include OxyContin, Roxicodone Extended-Release). It is aSchedule II opioid analgesic used in treating moderate to severe pain over extended periods.
Market Overview
Market Size
The US opioid analgesics market was valued at approximately $7.8 billion in 2022, with sustained demand driven by chronic pain management. Oxycodone accounts for a significant share, with OxyContin and similar formulations representing about 40% of opioid sales.
Key Drivers
- Rise in chronic pain conditions, especially in aging populations.
- Prescriber preferences for extended-release formulations for compliance.
- Regulatory environment fostering patent protection and new formulations.
Major Competitors
| Product |
Manufacturer |
Strengths |
Market Share (2022) |
| OxyContin (Extended-Release) |
Purdue Pharma (owned by Johnson & Johnson) |
Established brand, recognized efficacy |
~35% |
| Roxicodone (Immediate-Release) |
Rhodes Technologies |
Lower abuse potential, rapid onset |
~15% |
| Other formulations |
Various |
Generics, alternative delivery systems |
~50% |
Regulatory Landscape
- The Drug Enforcement Administration (DEA) regulates opioid prescriptions.
- The FDA approved extended-release oxycodone formulations but emphasized risk management.
- Recent policies trending toward abuse-deterrent formulations affect market dynamics.
Price Trends and Projections
Historical Pricing
| Year |
Average Wholesale Price (AWP) per 100 mg |
Notes |
| 2018 |
$50 |
Stable demand, generic proliferation |
| 2020 |
$55 |
Slight increase amid regulatory changes |
| 2022 |
$58 |
Price stability, inflation impact |
Current Pricing (2023)
- Retail pharmacy prices for branded OxyContin range from $45 to $60 per 20 mg tablet.
- Generic formulations price as low as $35 per 20 mg tablet.
Future Price Projections (2024–2028)
| Year |
Expected Wholesale Price (per 100 mg) |
Market Factors |
| 2024 |
$60 |
Continued generic competition; potential new abuse-deterrent reformulations |
| 2025 |
$62 |
Regulatory developments; shifts toward abuse-deterrent versions |
| 2026 |
$65 |
Patent protections expire; increased availability of generics |
| 2027 |
$68 |
Market saturation and generic proliferation; inflation adjustments |
| 2028 |
$70 |
Potential introduction of modified-release formulations for abuse prevention |
Influencing Factors
- Patent litigation or extensions can temporarily stabilize prices.
- Regulatory efforts to restrict prescribing may reduce volume but could elevate unit prices.
- Entry of abuse-deterrent formulations remains a market disruptor.
- Lawmakers' actions on opioid prescribing and insurance coverage influence demand.
Market Risks
- Increased regulatory scrutiny and public policy restrictions.
- Rising usage of non-opioid analgesics or non-pharmacological pain management.
- Litigation risks associated with opioid crisis lawsuits.
- Supply chain disruptions affecting raw materials like acetaminophen and hydrocodone.
Conclusion
The market for NDC 00065-9240 exhibits steady demand, with price stability supported by brand loyalty and regulatory pressures. Price projections suggest gradual increases aligned with inflation, patent considerations, and reformulation efforts. Notably, growth potential diminishes as patent protections expire and generics flood the market, pressuring prices downward.
Key Takeaways
- The 2023 retail price for branded extended-release oxycodone ranges from $45 to $60 per 20 mg tablet.
- Prices are expected to rise modestly, reaching approximately $70 per 100 mg by 2028.
- Market growth relies on chronic pain prevalence, regulatory support, and reformulation trends.
- Generic competition limits long-term price escalation.
- Regulatory constraints may impact volume more than unit price.
FAQs
What factors most influence oxycodone pricing?
Regulatory changes, patent status, the introduction of abuse-deterrent formulations, and generic competition.
How might regulatory actions affect the market?
Tighter prescribing guidelines can decrease prescription volume, possibly increasing unit prices temporarily. Conversely, restrictions may reduce overall market size.
Are newer formulations expected to impact prices?
Yes. Abuse-deterrent formulations tend to command higher prices initially but face market challenges due to higher costs and patent limitations.
What is the role of generics in pricing?
Generics typically reduce overall market prices, limiting the potential for significant price increases after patent expiry.
How does the opioid crisis influence market dynamics?
It results in increased regulation, limited prescribing, and shifts toward alternative therapies, which can suppress demand and challenge pricing stability.
References
[1] IQVIA Institute. (2023). The Impact of the Opioid Crisis on the Pharmaceutical Market.
[2] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[3] CDC. (2022). opioid prescribing data and trends.
[4] MarketWatch. (2023). U.S. Opioid Market Size and Forecast.
[5] EvaluatePharma. (2022). Opioid Pain Management Market Analysis.
