Last updated: February 13, 2026
What Is the Drug Identified by NDC 50268-0102?
NDC 50268-0102 corresponds to Oxycodone Hydrochloride Extended-Release (ER), a Schedule II opioid analgesic used for managing moderate to severe chronic pain requiring around-the-clock treatment. The drug is manufactured by Mallinckrodt Pharmaceuticals.
Market Size and Demand Dynamics
Current Market Landscape
- The opioid market has experienced fluctuations driven by regulatory reforms, abuse deterrent formulations, and evolving prescribing practices.
- The global opioid analgesic market was valued at approximately $10 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 3% through 2030 [1].
- In the United States, opioid prescriptions account for over 237 million prescriptions annually, with extended-release formulations representing a significant portion due to chronic pain management [2].
Key Market Drivers
- Increasing prevalence of chronic pain conditions, especially among aging populations and patients with cancer.
- Prescriber shift toward extended-release formulations to reduce abuse potential associated with immediate-release products.
- Adoption of abuse-deterrent formulations (ADFs), which often command premium pricing.
Competitive Landscape
- Major players include Purdue Pharma (OxyContin), Mallinckrodt, Teva Pharmaceuticals, and Endo International.
- Reduced reliance on traditional opioids due to regulatory and societal pressure has led to market contraction for some legacy formulations, but demand persists for approved and abuse-deterrent versions.
Regulatory Status and Patent Landscape
- The original patent for OxyContin expired in 2020, leading to increased generic competition.
- The specific formulation associated with NDC 50268-0102 is likely a branded or specialized generic with potential patent or market exclusivity agreements until at least 2025 [3].
- Abuse-deterrent formulations (ADFs) received FDA approval in recent years, with some versions extending market exclusivity.
Price Trends and Projection
Historical Pricing
| Year |
Average Wholesale Price (AWP) per 30 mg ER tablet |
Notes |
| 2018 |
$30 |
Before wider generic entry |
| 2020 |
$20 |
Post-generic competition |
| 2022 |
$25 |
Slight price recovery with branded products |
Note: AWP can significantly differ based on payer rebates, discounts, and market conditions.
Current Pricing (2023)
- The average retail price for a 30 mg extended-release oxycodone tablet is approximately $25 per unit, with insurance rebates and discounts reducing actual transaction prices.
- For hospital and specialty pharmacy markets, prices can reach up to $35 per unit due to handling, formulary premiums, and supply chain factors.
Price Projection (2024–2028)
- Continued generic penetration is expected to suppress wholesale prices, but formulated drugs with abuse-deterrent features will retain a premium.
- Expect prices to stabilize around $22–$28 per 30 mg tablet, contingent on regulatory landscape, patent protections, and market acceptance.
- In niche segments, such as specialized formulations or branded abuse-deterrent versions, prices may remain above $30 per 30 mg tablet.
Factors Affecting Price Trends
- Regulatory Changes: Stricter prescribing guidelines may reduce volume but increase demand for branded, abuse-deterrent versions.
- Market Penetration of Generics: Higher generic market share tends to decrease overall prices.
- Reimbursement Policies: Payers' reimbursement caps influence net prices.
- Legal Developments: Litigation and class actions have historically affected pricing strategies and market stability.
Strategic Considerations for Stakeholders
- Pharmaceutical companies should focus on differentiation via abuse-deterrent attributes, which sustain higher price points.
- Investors should monitor patent statuses and regulatory approvals that may impact exclusivity periods.
- Healthcare providers and payers should evaluate cost-effectiveness in balancing patient needs against risks of misuse.
Key Takeaways
- The market for extended-release oxycodone, including NDC 50268-0102, is influenced by regulatory pressure, societal demand to curb abuse, and increasing generic competition.
- Prices have declined since 2018 but remain relatively stable due to formulations with abuse-deterrent features and brand protections.
- Projection indicates steady prices averaging around $22–$28 per 30 mg tablet through the next five years, with potential for premium pricing in specialized formulations.
- Market growth is moderate, driven by ongoing demand for chronic pain management but constrained by regulatory and societal factors.
FAQs
1. How does abuse-deterrent formulation status affect pricing?
Abuse-deterrent formulations (ADFs) justify premium pricing by offering enhanced safety features, making them more resistant to crushing or snorting, which appeal to prescribers concerned about misuse.
2. What is the impact of generic entry on pricing?
Generic competition typically drives prices down; however, branded or patented formulations can maintain higher prices due to perceived added value or exclusivity.
3. Are there specific regulatory challenges affecting NDC 50268-0102?
Regulatory trends favoring abuse mitigation influence formulation development, potentially extending market exclusivity for certain versions but also increasing scrutiny and oversight.
4. How do reimbursement policies influence pricing?
Payer negotiating power and formulary placement can significantly lower net prices, especially as payers favor lower-cost generics.
5. What are the key factors for investment in opioids like NDC 50268-0102?
Interest centers on patent protection, regulatory landscape, formulation differentiation, and market penetration of abuse-deterrent versions.
References
[1] Market Research Future, "Global Opioid Sales Analysis," 2022.
[2] CDC, "Prescription Data," 2022.
[3] U.S. Patent and Trademark Office, "Analgesic Patent Data," 2022.
