Last updated: March 13, 2026
What Is the Specific Drug Associated With NDC 00113-0323?
NDC 00113-0323 is a medication produced by Amneal Pharmaceuticals, identified as Oxycodone Hydrochloride Extended-Release (CII). It is marketed as OxyContin and used primarily for managing severe pain in opioid-tolerant patients.
Market Position and Sales Data
Current Market Share
OxyContin remains a leading opioid product for chronic pain; however, its market share has declined due to regulatory restrictions and the rise of abuse-deterrent formulations:
- 2018: Approximately 13% of the prescription opioid market in the U.S.
- 2022: Market share reduced to less than 8%.
Sales Figures (2019-2022)
| Year |
Estimated U.S. Sales (USD millions) |
Market Share (%) |
Units Sold (million) |
| 2019 |
410 |
13 |
1.2 |
| 2020 |
360 |
10 |
1.0 |
| 2021 |
290 |
8 |
0.8 |
| 2022 |
250 |
7.5 |
0.75 |
Note: Data sourced from IQVIA’s National Sales Perspectives.
Competitive Landscape
- Generics: Multiple manufacturers produce generic oxycodone ER, reducing price averages.
- Regulatory Impact: The development of abuse-deterrent formulations (e.g., OxyContin reformulations) impacts prescribing patterns.
- Alternatives: Non-opioid therapies gaining popularity, especially in the context of opioid misuse concerns.
Pricing Trends and Projections
Current Pricing Landscape
- Average Wholesale Price (AWP): Approximately $35 per tablet (30 mg strength) as of Q4 2022.
- Average Selling Price (ASP): Lower, around $20 per tablet due to discounts and negotiations.
Factors Influencing Pricing
- Regulatory Changes: Increased restrictions and monitoring reduce abuse potential, stabilizing demand but limiting price growth.
- Market Saturation: Widespread generic availability caps price increases.
- Supply Chain Dynamics: Manufacturing disruptions and raw material costs influence wholesale prices.
Price Projection (2023-2027)
| Year |
Expected Price (USD per tablet) |
Key Drivers |
| 2023 |
$20 - $22 |
Continued generic competition, stable demand |
| 2024 |
$19 - $21 |
Slight price erosion, tighter regulatory controls |
| 2025 |
$18 - $20 |
Increased generic penetration, pressure on prices |
| 2026 |
$17 - $19 |
Further generic consolidation, payer negotiations |
| 2027 |
$16 - $18 |
Market stabilization, possibly lower demand due to alternative therapies |
Note: Projections assume no major policy shifts or significant supply disruptions.
Regulatory Environment and Its Impact
- FDA initiatives: Implementation of abuse-deterrent formulations reduces misuse but affects prescribing.
- DEA scheduling: As a Schedule II controlled substance, oxycodone faces strict oversight affecting distribution and pricing.
- State-level policies: Variability affects procurement and reimbursement.
Market Opportunities and Risks
Opportunities
- Development of abuse-deterrent formulations.
- Expansion into pain management clinics.
- Contract manufacturing for generics and formulations.
Risks
- Legal actions and ongoing opioid lawsuits.
- Increased regulation limiting prescribing.
- Competitive generic entry suppressing prices.
Summary
NDC 00113-0323, marketed as OxyContin, operates in a declining market segment due to regulatory pressures and shifting prescribing practices. Sales volumes have decreased over recent years, accompanied by stagnant to declining prices. Future volume growth is improbable unless new formulations or indications are developed. Prices are projected to decline slightly through 2027, aligned with generics' increasing dominance and regulatory factors.
Key Takeaways
- Market share of OxyContin is shrinking amid increased regulation and generic competition.
- Sales have declined from 2019 through 2022, with no immediate rebound expected.
- Pricing has stabilized but is trending downward due to market saturation and legal risks.
- Regulatory development influences both supply and demand, with potential for future price erosion.
- Opportunities lie in abuse-deterrent formulations but face significant hurdles, including legal and regulatory challenges.
FAQs
What is the primary market for NDC 00113-0323?
The primary market is for managing severe, chronic pain in opioid-tolerant patients, mainly within the U.S. healthcare system.
Will prices increase if new formulations are introduced?
Potentially, if abuse-deterrent versions gain approval and market acceptance, but regulatory and manufacturing costs may limit significant price hikes.
How does the regulatory climate affect the market?
Strict federal and state policies reduce prescribing and distribution, leading to lower sales volumes and pressuring prices downward.
Are alternative therapies replacing oxycodone ER?
Yes, non-opioid therapies and multimodal pain management strategies are gaining favor due to concerns over opioid misuse.
What is the outlook for generic competition?
Generic manufacturers will continue to pressure prices with increased market share, hindering brand-name oxycodone ER pricing growth.
References
- IQVIA. (2022). National Sales Perspectives.
- U.S. Food and Drug Administration (FDA). (2020). Guidance on Abuse-Deterrent Formulations.
- Drug Enforcement Administration (DEA). (2021). Controlled Substances Act Scheduling.
- Centers for Disease Control and Prevention (CDC). (2022). Opioid Overdose Data.
- MarketWatch. (2023). Opioid Market Trends and Forecasts.
