Last updated: February 21, 2026
What is the drug associated with NDC 71205-0935?
The National Drug Code (NDC) 71205-0935 corresponds to an NDA-approved medication. Based on the Food and Drug Administration (FDA) database, this NDC is associated with Oxycodone Hydrochloride Extended-Release Tablets, 10 mg.
Market Overview
Current Market Size and Demand
The demand for extended-release opioid medications such as oxycodone has remained high due to use in chronic pain management. According to IQVIA data, the total opioid analgesics market generated approximately \$8.4 billion in 2022 in the U.S.
- Oxycodone formulations account for approximately 35% of total opioid prescriptions.
- Oxycodone extended-release medications hold a significant market share, driven by patient preference for controlled, long-acting pain relief.
Regulatory Environment and Market Trends
The opioid market faces increasing regulatory scrutiny because of the opioid epidemic. Stricter prescribing guidelines and reimbursement policies influence market stability:
- The CDC recommends cautious opioid prescribing.
- Many payers restrict coverage of high-dose opioids.
- Manufacturers are developing abuse-deterrent formulations and non-opioid alternatives.
Competition
Major oxycodone extended-release products include:
- OxyContin (Purdue Pharma); dominates with an estimated $1.3 billion in 2022 sales.
- Xtampza ER (Collegium); gaining market share with abuse-deterrent technology.
- Generic oxycodone ER products; account for over 60% of prescriptions due to price sensitivity.
The product associated with NDC 71205-0935 is likely a generic or branded version of oxycodone ER.
Price Analysis
Historical Pricing Trends
- Average wholesale price (AWP): ( \sim \$3.50 ) per 10 mg tablet (as of 2022).
- Average manufacturing cost: Estimated at ( \$0.20 ) to ( \$0.50 ) per tablet, considering active ingredients, excipients, and packaging.
- Brand vs. generic: Generic versions typically retail at 40-60% discount compared to branded products.
Price Projections
Short-term (next 12 months):
- Prices are expected to remain stable amid regulatory and market saturation.
- A minor decrease of 5-10% is possible due to increased generic competition.
Medium-term (2-3 years):
- Introduction of abuse-deterrent or reformulated versions could raise costs by 10-15%.
- Market consolidation or shortages could temporarily elevate prices.
Long-term (4-5 years):
- Prices may decline by 10-20% with increased generic availability.
- Regulatory restrictions or legislation targeting opioid prescribing could reduce overall market volume by up to 25%.
Pricing Variance by Payer
- Medicaid and Medicare: Reimburse at negotiated rates, averaging \$2.50 to \$3.00 per tablet.
- Private insurers: Reimburse up to \$3.50.
- Out-of-pocket (cash): Retail prices hover at \$4.00 to \$6.00 per tablet.
Market Entry and Opportunities
Despite legal and social constraints, demand remains steady primarily due to existing chronic pain patients.
- Manufacturer focus: Developing abuse-deterrent formulations and non-opioid alternatives.
- Opportunities: Entering the generic market for oxycodone ER with competitive pricing or differentiated formulations.
Key Regulatory and Policy Drivers
| Policy/Regulation |
Impact |
Implementation Date |
| CDC Guidelines on Opioids |
Limits on prescribing high-dose opioids |
2016 |
| FDA Abuse-Deterrent Labeling |
Incentivizes abuse-deterrent formulations |
2013 |
| State Prescription Drug Monitoring Programs |
Reduce diversion and misuse |
Varies by state (2010–2022) |
Competitive Pricing Strategies
- Use economies of scale to reduce manufacturing costs.
- Implement cost-effective distribution channels.
- Invest in patient education and compliance programs benefiting insurers and providers.
Summary
The oxycodone ER market remains sizable but is under pressure from regulatory controls, market saturation, and the availability of alternative therapies. Price points are expected to stay relatively stable over the next year, with potential declines driven by generic competition. Strategic positioning involves competitive pricing, product differentiation (e.g., abuse-deterrence), and ongoing regulatory adaptation.
Key Takeaways
- The drug associated with NDC 71205-0935 is likely a generic or branded oxycodone ER.
- Market size in the U.S. opioids sector exceeds \$8 billion annually, with oxycodone ER comprising a significant share.
- Prices are forecasted to stabilize, with slight declines due to increased generic competition.
- Regulatory policies and societal issues will continue shaping the market landscape.
- Opportunities exist in cost leadership, abuse-deterrent formulations, and alternative pain management therapies.
FAQs
1. How does the market for oxycodone ER compare internationally?
International markets are more restricted; the U.S. dominates due to high demand and prescribing patterns. In Europe, opioid prescribing is generally more conservative, limiting market size.
2. What are the primary challenges for new entrants in this market?
Regulatory barriers, high competition from established brands and generics, and increasing scrutiny on opioid prescribing limit new entry.
3. How will legislative changes affect pricing?
Legislation aiming to curb misuse could reduce demand, pressure prices downward, and restrict reimbursement policies.
4. Are alternative therapies impacting market growth?
Yes. Non-opioid pain therapies, including nerve blocks, anticonvulsants, and alternative medicine, reduce reliance on opioids, affecting long-term market potential.
5. What role does abuse-deterrence play in future pricing?
Abuse-deterrent formulations typically command higher prices (~20-30% premium). Their adoption influences overall pricing trends and product differentiation strategies.
Sources:
- IQVIA. (2023). Opioid Market Reports.
- FDA. (2013). Abuse-Deterrent Opioid Labeling.
- CDC. (2016). Guidelines for Prescribing Opioids.
- U.S. Department of Health and Human Services. (2022). Prescription Drug Monitoring Program Data.
- MarketWatch. (2022). Analysts on Opioid Market Trends.
