Last updated: February 25, 2026
What is NDC 00093-7387?
NDC 00093-7387 identifies a specific formulation of Oxycodone Hydrochloride extended-release tablets. It is marketed under a branded name by Purdue Pharma. The medication is classified as an opioid analgesic used for managing chronic pain unresponsive to other treatments.
Market Size and Trends
Current Market Overview
- Global Market Value (2022): Estimated at \$4.5 billion, driven by rising opioid prescriptions for chronic pain.
- U.S. Market Share: Approximately 70%, with revenue nearing \$3.2 billion.
- Prescription Volume: Approximately 50 million prescriptions annually in the U.S. (IQVIA, 2022).
Market Drivers
- Increasing prevalence of chronic pain conditions affecting 30-40% of adults in the U.S.
- Persistent off-label use for pain management.
- Higher utilization in oncology and palliative care.
Market Barriers
- Regulatory restrictions targeting opioid abuse.
- Growing emphasis on opioid-sparing approaches.
- Implementation of Prescription Drug Monitoring Programs (PDMPs).
Competitive Landscape
| Product Name |
Manufacturer |
Formulation |
Price per unit (approximate) |
Year Introduced |
Notes |
| OxyContin (extended-release) |
Purdue Pharma |
10 mg, 20 mg, 40 mg, ... |
\$30–\$50 per 30 pills |
1996 |
Market leader, long-standing |
| Xtampza ER |
Collegium Pharmaceutical |
9 mg, 13.5 mg, 18 mg, ... |
\$40–\$60 per 30 pills |
2016 |
Abuse-deterrent formulation |
| Roxicodone (immediate-release) |
Roxane Laboratories |
5 mg, 15 mg, 30 mg |
\$10–\$15 per pill |
1950s |
Less relevant for extended-release indications |
Regulatory Environment
- The Drug Enforcement Agency (DEA) classifies it as schedule II.
- FDA approval dates influence market stability.
- REMS programs enforce prescribing guidelines and limit distribution to minimize abuse potential.
Price Projections (Next 5 Years)
Factors Influencing Price Trends
- Regulatory constraints: Heightened restrictions could limit availability and raise prices.
- Generic entry: Patent expirations typically reduce prices; however, patent extensions or litigation could delay generics.
- Abuse-deterrent innovations: New formulations may command premium prices.
- Healthcare policies: Focused on opioid reduction programs may depress overall demand.
Assumptions
- Patent protection expires in 2024, opening the market for generics.
- Patent litigations extend exclusivity until 2026.
- No major regulatory reforms significantly alter prescribing behaviors in the short term.
Price Trajectory Forecast
| Year |
Estimated Average Price per 30-pill Pack |
Notes |
| 2023 |
\$150–\$180 |
Maintain current pricing, slight inflation |
| 2024 |
\$120–\$150 |
Patent expiration prompts entry of generics |
| 2025 |
\$80–\$110 |
Increased generic competition reduces price |
| 2026 |
\$75–\$100 |
Dominance of generics stabilizes prices |
| 2027 |
\$70–\$95 |
Market stabilizes, minor fluctuations |
Key Considerations
- Gilead-like patent litigation cases could protract exclusivity.
- The adoption of abuse-deterrent formulations in the generics can sustain higher prices.
- The impact of federal and state policies on opioid prescribing will crucially affect demand and pricing.
Summary
The market for NDC 00093-7387 is expected to decline from a current premium pricing level due to patent expiration and generic competition. Prices are projected to decrease sharply within two years post-patent expiry but may stabilize with new abuse-deterrent formulations maintaining a premium over standard generics.
Key Takeaways
- Market size remains substantial but faces decline with generic entry.
- Pricing will dip from around \$150–\$180 per 30-pack in 2023 to \$70–\$100 in 2026.
- Regulatory and policy developments heavily influence market dynamics.
- Abuse-deterrent features could sustain higher prices for newer or reformulated generics.
- The overall trend aligns with typical lifecycle patterns of branded opioids facing patent cliffs.
FAQs
Q1: When does the patent for NDC 00093-7387 expire?
A1: Patent expiry is expected in 2024, though litigation or extensions could delay generic entry until 2026.
Q2: How will regulatory changes affect prices?
A2: Increased restrictions and manufacturing adjustments aimed at reducing abuse could lower demand and lead to price reductions.
Q3: Are there existing generic equivalents?
A3: As of 2023, no approved generics are available, but filings are expected following patent expiration.
Q4: What is the significance of abuse-deterrent formulations?
A4: These formulations can command higher prices and potentially extend market dominance for branded versions or reformulated generics.
Q5: How does market competition impact overall profitability?
A5: Entry of generics typically reduces margins for branded products but increases overall volume and accessibility.
References
[1] IQVIA. (2022). The Impact of COVID-19 on the Use of Opioid Medications.
[2] U.S. Food and Drug Administration. (2021). Oxycodone Extended-Release.
[3] U.S. Drug Enforcement Agency. (2022). Controlled Substances Schedule.
[4] MarketWatch. (2023). Opioid Market Trends and Pricing Analysis.
