Last updated: March 2, 2026
What is the drug with NDC 00093-7701?
The National Drug Code (NDC) 00093-7701 corresponds to Oxycodone Hydrochloride Extended-Release. This opioid analgesic, marketed primarily under the brand name OxyContin, is used for managing moderate to severe pain in opioid-tolerant patients.
Market Overview
Product Details
| Attribute |
Details |
| Brand Name |
OxyContin (extended-release oxycodone) |
| Manufacturer |
Purdue Pharma (original), numerous generics |
| Formulations |
Tablets (10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg) |
| Approval Date |
1995 (OxyContin release) |
| Therapeutic Class |
Opioid analgesic |
Market Size and Trends
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The global opioid analgesics market was valued at USD 8.2 billion in 2021.
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The U.S. accounts for approximately 60% of this market.
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Growth drivers include rising chronic pain prevalence, aging population, and expanding pain management therapies.
Market Players
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Purdue Pharma (original manufacturer)
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Teva Pharmaceuticals, Mallinckrodt, Sun Pharma, and other generics producers
-
Regulatory actions and patent expirations influence market dynamics.
Price Trends and Projections
Historical Pricing (U.S. Market, Retail/Wholesale)
| Year |
Average Wholesale Price (AWP) per 30-count 30 mg tablets |
Notes |
| 2018 |
USD 800 |
Data from Medi-Span |
| 2019 |
USD 750 |
Slight decline observed |
| 2020 |
USD 700 |
Pandemic impact; increased generics |
| 2021 |
USD 680 |
Continued decline, market saturation |
Current Pricing (2023)
Price Influence Factors
-
Patent status: The original patent expired in 2013; numerous generics entered the market.
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Regulatory actions: The Drug Enforcement Administration (DEA) classifies oxycodone as Schedule II, influencing manufacturing and distribution costs.
-
Insurance and pharmacy benefit managers (PBMs) influence actual consumer prices.
Future Price Projections
| Year |
Projected WAC per 30 tablets (30 mg) |
Assumptions |
| 2024 |
USD 20-30 |
Increased generic competition, market saturation |
| 2025 |
USD 20-25 |
Price stabilization anticipated |
| 2026 |
USD 20-25 |
Market equilibrium maintained |
Factors leading to price stability include:
-
Market saturation with multiple generics
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Ongoing regulatory scrutiny and cost efficiencies
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Potential legislative impacts on opioid prescribing limits
Market and Price Risks
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Heightened opioid regulation, including stricter prescribing guidelines, can restrict sales volume.
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Legal liabilities and settlements from opioid litigation could impact manufacturers' market presence and pricing strategies.
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Increasing use of abuse-deterrent formulations (ADFs) may alter pricing structures and market share.
Regulatory Environment
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The FDA enforces risk management programs for opioids, including REMS (Risk Evaluation and Mitigation Strategies).
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The DEA's scheduling and enforcement actions restrict distribution channels, influencing market access.
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Patent expirations and generics entry have driven down prices but may face future patent litigations.
Key Market Opportunities and Challenges
Opportunities
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Growing demand for pain management solutions in aging populations.
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Expansion into emerging markets with limited opioid access.
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Development of abuse-deterrent formulations to command premium prices.
Challenges
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Rising regulatory hurdles limiting prescriptions.
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Litigation risks and associated costs.
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Public health initiatives reducing opioid consumption.
Conclusion
The market for extended-release oxycodone under NDC 00093-7701 remains sizable but is characterized by declining prices driven by patent expirations and increasing generic competition. Price per 30 tablets (30 mg) is expected to stabilize around USD 20-30 in the near term. Market growth hinges on regulatory context, public health policies, and the evolution of pain management therapies.
Key Takeaways
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The product identified by NDC 00093-7701 is an extended-release oxycodone widely used in pain management.
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The global opioid market is consolidating, with increased generic competition suppressing prices.
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Average wholesale prices for 30-tablet, 30 mg formulations are projected to stay between USD 20-30 in the next two years.
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Regulatory policies and litigation risks could influence supply, demand, and pricing strategies.
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Opportunities lie in developing abuse-deterrent formulations and entering emerging markets, while challenges include tightening regulations and public health interventions.
FAQs
1. What is the current market size for extended-release oxycodone?
The U.S. opioid analgesics market was USD 4.9 billion in 2021, with oxycodone comprising a significant portion, estimated at USD 2.9 billion.
2. How do patent expirations affect drug prices?
Patent expirations open markets to generics, generally reducing prices through increased competition.
3. Are there legal risks associated with this drug?
Yes. Manufacturers face litigation risks related to opioid misuse, abuse, and public health impacts.
4. What is the regulatory outlook for opioid drugs?
Regulatory agencies enforce strict prescribing guidelines, risk management programs, and monitor abuse trends. Future regulations may further restrict access.
5. How might new formulations impact the market?
Abuse-deterrent formulations can command higher prices and capture market share but face regulatory hurdles and high development costs.
References
[1] Statista. (2022). Global opioid market size.
[2] U.S. Food and Drug Administration. (2022). Opioid pain medications REMS.
[3] IQVIA. (2022). US Prescription Drug Data.
[4] Medscape. (2022). Opioid trends and market data.
[5] U.S. DEA Office of Diversion Control. (2023). Drug Scheduling and Regulations.
