Last updated: February 19, 2026
What Is the Drug?
NDC 16571-0813 is identified as Oxymorphone Extended-Release Tablets, 10 mg. It is a Schedule II opioid analgesic supplied by Upsher-Smith Laboratories. The drug is primarily used for management of chronic severe pain where other pain management options are inadequate.
Market Status and Penetration
Current Market Landscape
- The opioid analgesic market faces increased regulation due to the opioid epidemic.
- Prescriptions for oxymorphone have declined in recent years, with a shift toward abuse-deterrent formulations and alternative pain therapies.
- Estimated U.S. prescriptions for oxymorphone ER (including NDC 16571-0813) are approximately 1.2 million annually, down from a peak of 2.5 million in 2017 [1].
Competitive Position
- Main competitors include products such as OxyContin (oxycodone ER), Xtampza ER (oxycodone), and newer abuse-deterrent formulations.
- Less regulatory pressure compared to other opioids, but potential for increased scrutiny remains.
Regulatory Environment
- FDA approval date: August 2010.
- Post-marketing requirements include risk evaluation and mitigation strategies (REMS) to reduce abuse.
- Pending legislation could impact prescribing patterns, especially with increased emphasis on non-opioid pain management.
Market Trends and Drivers
Demand Factors
- Chronic pain prevalence in the U.S. exceeds 50 million adults.
- Aging population increases demand for potent analgesics.
- Shift toward telemedicine mildly expands access to opioids but also heightens regulatory oversight.
Challenges
- Growing awareness of opioid addiction and misuse.
- Price controls and insurer restrictions limit patient access.
- Development of abuse-deterrent formulations and alternative pain management options.
Price Trends and Projections
Current Price Point
- Average Wholesale Price (AWP): Approximately $92 per 30-count bottle of 10 mg tablets [2].
- Retail pharmacy acquisition cost: Estimated at 15-20% below AWP.
- Mean Medicaid reimbursement (2019): $85 per 30-count, 10 mg tablets [3].
Price Drivers
- Increased regulatory oversight constrains pricing power.
- Sparse generic competition: No authorized generics, but some off-label alternative formulations exist.
- Price erosion observed over the past three years averages 4-6% annually, driven by payer negotiations and volume discounts.
Short-Term Outlook (Next 12-24 months)
- Prices likely to remain stable due to limited alternatives and ongoing demand.
- Small decrease expected due to payer pressure, averaging 2-4% annually.
- Price stabilization is probable unless legislative or regulatory changes introduce new restrictions or force formulation changes.
Long-Term Outlook (Next 3-5 years)
- Potential decline of 10-15% if new abuse-deterrent formulations or non-opioid alternatives gain acceptance.
- Impact of stricter prescribing guidelines could further reduce prescribing volume, applying downward pressure on prices.
- Conversely, supply chain disruptions or intentional price inflation due to manufacturing costs could temporarily stabilize or increase prices.
Key Variables Impacting Future Market and Pricing
| Variable |
Effect |
| Regulatory changes |
Stricter regulations may decrease demand or increase compliance costs |
| Prescribing patterns |
Increased use of non-opioid therapies reduces demand |
| Development of abuse-deterrent formulations |
Could maintain demand with improved safety profile |
| Healthcare policies and laws |
Reimbursement policies influence supply and pricing |
| Competition |
Entry of generics and new formulations supplies pressure on prices |
Summary Table: Price Projections (Next 3-5 Years)
| Year |
Estimated AWP (per 30-count, 10 mg) |
Estimated Retail Price |
Price Change (%) (Annually) |
| 2023 |
$92 |
$79-$92 |
0-2% decrease |
| 2024 |
$89-$91 |
$76-$89 |
2-4% decrease |
| 2025 |
$85-$88 |
$73-$85 |
4-6% decrease |
Key Takeaways
- Growth in demand stagnates due to regulatory and societal pressures.
- Prices for NDC 16571-0813 are stable but face gradual erosion driven by payer negotiations and legislative actions.
- Long-term decline expected if non-opioid treatments and abuse-deterrent formulations expand market share.
- Supply-side issues or policy shifts could induce temporary price volatility.
FAQs
-
What factors are most influencing the price of NDC 16571-0813?
Regulatory environment, prescribing trends, competition from generics or alternative therapies, and payer strategies.
-
Is there potential for significant price increases?
Unlikely in the short-term without supply shortages or major regulatory changes.
-
How does regulatory pressure impact future sales?
Tighter controls likely reduce prescribing volumes, constraining revenue growth.
-
Are generic alternatives available?
No authorized generics; off-label or compounded drugs exist but do not directly compete on price.
-
What role do insurance companies play in pricing?
Payer negotiations can significantly lower actual reimbursement rates and influence retail prices.
References
[1] IQVIA, "Prescribing Trends and Market Insights," 2022.
[2] Red Book Online, "Average Wholesale Price (AWP) Data," 2023.
[3] Medicaid State Data, "Pricing and Reimbursement Reports," 2019.
Note: Some data projections involve assumptions based on recent trends; actual market conditions may vary.
