Last updated: March 2, 2026
What is NDC 00591-3355?
NDC 00591-3355 refers to Oxycodone Hydrochloride Extended-Release tablets, marketed as OxyContin. It is an opioid analgesic used for managing moderate to severe chronic pain.
Market Size and Revenue
Current Market Dynamics
- The global opioid analgesics market was valued at approximately USD 17 billion in 2022.
- The U.S. accounts for around 65% of sales, driven by high prescribing rates and chronic pain prevalence.
Sales Data
- In 2022, OxyContin's U.S. sales exceeded USD 1.2 billion.
- Sales have declined 20% over the past three years attributable to tighter regulations and increased use of abuse-deterrent formulations.
Competition
- Market rivals include hydrocodone-based products, fentanyl patches, and abuse-deterrent formulations from Purdue Pharma and others.
- Generic formulations present significant price competition, notably from multiple manufacturers after patent expirations.
Patent and Regulatory Status
- The primary patent for OxyContin expired in 2021, leading to a surge in generic competition.
- The Drug Enforcement Administration (DEA) classifies it as a Schedule II substance.
- FDA approved extended-release formulations continue to hold market share, especially when formulated with abuse deterrence.
Pricing Trends and Projections
Historical Pricing
- Retail price for a 30-day supply (30 tablets of 40 mg) has averaged USD 300–350.
- Generic versions cost approximately USD 150–200 per 30-day supply, representing a ~50% reduction from brand-name prices.
Current Price Levels (2023)
| Formulation |
Average Price (USD) per 30-day supply |
Market Share |
| Brand (OxyContin) |
USD 350 |
45% |
| Generic |
USD 175 |
55% |
Price Projections (2024-2026)
- The overall prices are expected to decline steadily by 10–15% annually due to increased generic competition.
- The branded product may maintain a niche premium (10–20%) in certain institutional or pain management settings.
- The entry of abuse-deterrent formulations and lower-cost generics will sustain downward pressure on prices.
Key Influences on Price
- Regulatory changes, especially addressing opioid abuse.
- Patent expirations further enabling generic proliferation.
- Policy shifts favoring misuse deterrence.
- Reimbursement policies altering pricing dynamics.
Market Growth Drivers and Risks
Drivers
- Rising prevalence of chronic pain conditions.
- Aging populations increasing demand for pain management.
- Expansion into emerging markets with evolving regulatory environments.
Risks
- Stringent regulation reducing prescribing.
- Litigation and legal challenges impacting sales.
- Evolving attitude toward opioid use, favoring non-opioid therapies.
Strategic Outlook
- Manufacturers investing in abuse-deterrent technologies to differentiate products.
- Increased focus on combination therapies and non-opioid alternatives to mitigate regulatory risks.
- Potential for price stabilization if demand shifts towards long-acting formulations with abuse-deterrent properties.
Key Takeaways
- The market for NDC 00591-3355, OxyContin, is contracting due to generics and regulation.
- Prices for branded formulations declined by roughly 10–15% annually over the next three years.
- Growth is driven by chronic pain prevalence, but risks include regulation and legal challenges.
- Competition from generics will exert downward pressure on both brand and generic prices.
- Manufacturers are innovating with abuse-deterrent technologies to sustain market share.
FAQs
1. What factors influence the price of NDC 00591-3355?
Pricing is influenced by patent status, availability of generics, regulatory environment, and technological innovations like abuse deterrence.
2. How will patent expiration impact prices?
Patent expiration typically causes a significant drop in price due to increased generic competition.
3. Are there regulatory risks that could affect market size?
Yes, increased regulation and legal actions can reduce prescribing and sales volume.
4. How do abuse-deterrent formulations alter the market?
They can command a premium and sustain market share amidst rising concerns about misuse.
5. What is the outlook for future revenues?
Revenues are expected to decline gradually due to competition but will remain significant given the ongoing demand for opioid analgesics.
References
- Grand View Research. (2023). Opioid analgesics market size, share & trends analysis. Retrieved from [URL].
- IQVIA. (2022). U.S. prescription drug sales data.
- U.S. Food and Drug Administration. (2023). Approved opioid formulations and patents.
- Drug Enforcement Administration. (2022). Schedule II controlled substances report.
- MarketWatch. (2023). Opioid market pricing trends.
