Last updated: February 13, 2026
What is the drug associated with NDC 00023-5301?
NDC 00023-5301 corresponds to a 40 mg oxycodone hydrochloride extended-release tablet, marketed primarily for chronic pain management. Produced by Purdue Pharma, it is branded as OxyContin.
What is the current market landscape for oxycodone extended-release formulations?
Market Size and Units Distributed:
- The global opioid analgesics market was valued at approximately US$10.1 billion in 2022.
- The U.S. accounts for >60% of the global demand, with oxycodone constituting a significant segment.
- In 2022, the National Prescription Audit (NPA) reported over 50 million opioid prescriptions in the U.S., with oxycodone products representing about 25%.
Key Market Players:
| Manufacturer |
Share (%) |
Products |
| Purdue Pharma |
45 |
OxyContin, generic oxycodone formulations |
| Teva Pharmaceuticals |
15 |
Generic oxycodone tablets |
| Sun Pharma |
10 |
Generics |
| Others |
30 |
Multiple smaller manufacturers |
Distribution Channels:
- Hospital and clinical settings: 40%
- Retail pharmacies: 55%
- Long-term care facilities: 5%
Regulatory and legal landscape
- The Drug Enforcement Agency (DEA) classifies oxycodone as a Schedule II substance, restricting prescribing and dispensing.
- The U.S. Food and Drug Administration (FDA) approved reformulated versions with abuse-deterrent properties to curb misuse.
- Several lawsuits against Purdue Pharma and other manufacturers have targeted aggressive marketing practices, influencing pricing and market dynamics.
Pricing Trends
Current Pricing (2023):
| Product Type |
Approximate Price (Per Unit) |
Remarks |
| Brand (OxyContin) |
US$45–US$60 (per 40 mg tablet) |
High due to brand recognition and patent protection |
| Generics |
US$2–US$5 (per 40 mg tablet) |
Lower cost, with multiple manufacturers |
Historical Price Changes:
- Prices for generic oxycodone have decreased marginally over the last five years, primarily due to increased generic competition.
- Brand formulations have maintained higher prices, with marginal increases linked to reformulations and marketing.
Forecasted Price Trajectory
| Year |
Projected Price Range (per 40 mg tablet) |
Assumptions |
| 2024 |
US$2.50–US$6.00 |
Continued generic competition, regulatory restraints |
| 2025 |
US$2.00–US$5.50 |
Slight price decline; patent expiration influence |
| 2026 |
US$1.80–US$5.00 |
Increasing generic entries, strict prescribing limits |
Factors influencing future prices:
- Patent expirations for branded products will expand generic market share, dampening prices.
- Regulatory pressures and provider shift to non-opioid alternatives may reduce demand.
- Legal settlements and litigation could impose additional costs or restrictions, affecting pricing.
Potential Impact of Policy and Market Shifts
- Introduction of abuse-deterrent formulations marginally increases manufacturing and retail costs but aims to sustain market share.
- Opioid prescribing restrictions are likely to lower overall volumes, impacting revenue.
- Competition from non-opioid analgesics (e.g., cannabinoids, NSAIDs) may reduce market size over time.
Key Takeaways
- The existing market for NDC 00023-5301 centers on high-demand, high-revenue opioids with a significant decline in prices expected due to generics and regulatory factors.
- Current retail price for a 40 mg oxycodone extended-release tablet ranges from US$2 to US$5.50, with brand versions commanding higher prices.
- The market is heavily influenced by legal, regulatory, and societal pressures aimed at reducing opioid misuse.
- Future pricing will trend downward, contingent on patent expirations and market competition.
FAQs
-
What is the main determinant of oxycodone price changes?
The transition from brand to generic formulations, regulatory approvals, and legal settlements.
-
How might regulations affect future demand?
Stricter prescribing limits may reduce overall demand, lowering prices and sales volumes.
-
Are abuse-deterrent formulations more expensive?
Yes, reformulated versions often cost more due to advanced technology but may help sustain market presence.
-
What distinguishes this formulation from other opioids?
The extended-release mechanism provides for chronic pain management, with a high potential for misuse if improperly used.
-
What is the outlook for generic manufacturers?
Increased competition is expected to drive prices lower, reducing profit margins but expanding volume share.
Citations
[1] IQVIA, "Opioids Market Overview," 2023.
[2] FDA, "Opioid Analgesic Approvals and Market Trends," 2022.
[3] DEA, "Controlled Substance Scheduling," 2023.
[4] Statista, "Global Opioids Market Size," 2022.
[5] U.S. CDC, "Opioid Prescriptions and Usage," 2022.
