Last updated: February 24, 2026
What is the Drug?
NDC 00054-0012 refers to Oxycodone Hydrochloride Extended-Release tablets. It is a Schedule II opioid analgesic indicated for managing moderate to severe pain requiring around-the-clock opioid therapy. The drug is primarily marketed under the brand name OxyContin.
Market Size and Demand
Current Market Overview:
- The U.S. opioid analgesics market was valued at approximately USD 9 billion in 2022.
- Oxycodone formulations account for roughly 25% of the total opioid market by revenue.
- The extended-release segment, including OxyContin and generic equivalents, constitutes around USD 2.4 billion annually.
Utilization Trends:
- Prescription volume for extended-release oxycodone decreased by 15% between 2020 and 2022, reflecting increased regulation and opioid stewardship efforts.
- Despite declines, demand stabilizes due to chronic pain management needs.
Key Competitors:
| Product Name |
Manufacturer |
Market Share |
Price (per unit) |
Formulation |
| OxyContin (Brand) |
Purdue Pharma |
40% |
USD 25 |
10 mg, extended-release |
| Generic oxycodone |
Multiple (e.g., Teva, Sandoz) |
50% |
USD 12-15 |
10 mg, extended-release |
| Other formulations |
Various |
10% |
Variable |
Extended-release or combinations |
Price Analysis
Historical Pricing (per 10 mg tablet):
- Brand (OxyContin): USD 25–30
- Generics: USD 12–15
Factors Influencing Price:
- Patents: OxyContin’s patent expiration has led to a surge in generic competition, reducing prices.
- Manufacturing costs: Rise in raw material prices has slight upward pressure on generics.
- Regulatory environment: Tight regulations on opioid prescription have impacted supply dynamics.
- Reimbursement policies: Medicare and private payers negotiate significant discounts.
Price Projections (Next 3 Years)
| Year |
Estimated Average Price per 10 mg Tablet |
Key Drivers |
| 2023 |
USD 13–16 |
Continued generic penetration, moderate demand stability |
| 2024 |
USD 13–15 |
Further generic expansion, regulatory clarity improves |
| 2025 |
USD 12–14 |
Price stabilization, increased competition |
Additional Considerations:
- Introduction of abuse-deterrent formulations may maintain higher prices.
- Policy shifts limiting opioid prescriptions could reduce overall volume, impacting revenue.
- Potential new formulations or alternatives could shift market dynamics.
Regulatory and Policy Impact
- The 2018 CDC guidelines aim to reduce opioid prescribing, affecting volume.
- The FDA’s approval of abuse-deterrent technology influences premium pricing.
- State-level legislative controls, such as Prescription Drug Monitoring Programs (PDMPs), limit misuse and availability, impacting sales volume.
Key Market Risks
- Increased competition from non-opioid analgesics.
- Federal and state regulations restrict prescribing.
- Public and insurer pushback against opioid use affecting reimbursements.
Investment and Commercial Strategy
- Focus on generic manufacturing to maximize margins.
- Invest in abuse-deterrent formulations to command premium prices.
- Monitor legal and regulatory developments for potential market disruptions.
Key Takeaways
- NDC 00054-0012 (Oxycodone Hydrochloride Extended-Release) faces a mature but declining market due to regulatory pressures.
- Price per unit has decreased from roughly USD 25–30 (brand) to USD 12–16 (generic).
- Price stability within USD 12–15 over the next three years depends on generic competition and regulatory landscape.
- Market share is dominated by generics, with innovation driven by abuse-deterrent technologies.
- Future growth is limited; market focus shifts toward optimizing production and compliance.
FAQs
1. How does patent expiration affect the price?
Patent expiration enables generic manufacturers to enter the market, increasing competition and reducing retail prices.
2. Will new formulations impact pricing?
Yes. Abuse-deterrent formulations typically command higher prices but may face adoption limits due to regulatory and prescriber preferences.
3. How do regulatory changes influence market volume?
Restrictions on prescribing opioids reduce overall sales volume, impacting revenue projections.
4. What are the main competitors?
The primary competitors are generic oxycodone products, which constitute over 50% of the market, along with branded OxyContin.
5. What is the outlook for price recovery?
Significant recovery is unlikely without regulatory relaxations or technological innovations; prices are expected to remain stable or decline slightly.
References
[1] IQVIA. (2023). "Opioid Market Trends & Insights."
[2] U.S. Food and Drug Administration (FDA). (2022). "Abuse-Deterrent Opioid Formulations."
[3] Centers for Disease Control and Prevention (CDC). (2021). "Opioid Prescribing Guidelines."
[4] MarketResearch.com. (2022). "Opioids Market Size & Forecast."
[5] Federal Register. (2018). "CDC Guideline for Prescribing Opioids for Chronic Pain."
