Last updated: March 3, 2026
What is the Drug with NDC 00173-0643?
NDC 00173-0643 corresponds to Oxycodone Hydrochloride Extended-Release. It is a Schedule II opioid analgesic used for managing moderate to severe chronic pain requiring around-the-clock therapy. The drug is marketed under various brand names, primarily OxyContin (Purdue Pharma), but also available as generic formulations.
Market Overview
Current Market Size
- The global opioid analgesic market was valued at approximately USD 12 billion in 2021.
- The North American market accounts for about 70% of global sales.
- The U.S. consumes roughly 75% of the world's opioids, with distribution dominated by branded drugs like OxyContin and generics.
- The extended-release opioid segment represents around 60% of prescription opioid sales due to its convenience and misuse potential.
Competitive Landscape
Primarily includes:
- Brand-name opioids: OxyContin (Purdue Pharma), Duragesic (fentanyl patches), Opana ER (Eli Lilly).
- Generics firms producing oxycodone ER formulations: Teva, Sandoz, Sun Pharma, and others.
Regulatory Environment
- In 2020, U.S. FDA issued warnings about opioid misuse, leading to increased scrutiny.
- Pemissions for new formulations are restricted to curb abuse.
- Ongoing lawsuits against Purdue Pharma and other manufacturers influence market dynamics and pricing strategies.
Key Drivers
- Chronic pain prevalence: 20% of adults report pain lasting over 3 months.
- Aging population increases demand.
- Pain management guidelines favor extended-release opioids for long-term therapy.
Price Trends Analysis
Historical Price Movements
| Year |
Average Wholesale Price (AWP) Per Unit |
Key Factors |
| 2018 |
USD 4.00 |
Rising generic competition, tighter regulation |
| 2019 |
USD 3.50 |
Increased generic availability |
| 2020 |
USD 3.00 |
COVID-19 pandemic impact, regulatory pressure |
| 2021 |
USD 2.70 |
Continued generic proliferation, lawsuits |
| 2022 |
USD 2.50 |
Pricing stabilization, market saturation |
Current Price Range
- Brand-name (OxyContin): USD 4.50 – USD 5.50 per unit.
- Generic versions: USD 2.00 – USD 3.00 per unit.
Factors Influencing Price
- Patent expirations allow generic entry, reducing prices.
- Regulatory pressures limit new formulations and access.
- Supply chain disruptions affect distribution costs.
- Litigation outcomes and government settlements influence market stability.
Price Projections (Next 3-5 Years)
| Year |
Projected Price Range Per Unit |
Key Assumptions |
| 2023 |
USD 2.30 – USD 2.80 |
Stable generic competition, no major regulatory shocks |
| 2024 |
USD 2.10 – USD 2.60 |
Increased generic market penetration, potential pricing pressure |
| 2025 |
USD 2.00 – USD 2.50 |
Market saturation, continued regulatory scrutiny |
| 2026 |
USD 1.80 – USD 2.20 |
Potential supply chain normalization, marginal demand shifts |
Market Entry and Growth Opportunities
- Generics dominate the market due to lower costs.
- Companies investing in abuse-deterrent formulations may command premium prices.
- Regulatory and legal developments could impact future pricing and market volume.
- Emerging markets represent growth opportunities due to rising chronic pain cases and expanding healthcare infrastructure.
Risks
- Increased regulatory restrictions and legal settlements could limit sales volume and influence prices.
- The opioid epidemic continues to impact prescribing behaviors and public perception.
- Competition from non-opioid pain management therapies may reduce market size over time.
Key Takeaways
- The market for oxycodone ER drugs is under downward pricing pressure due to patent losses, increased generics, and regulatory scrutiny.
- Prices are expected to decline gradually over the next five years, with stabilization at lower levels.
- Market growth hinges on legal stability, regulatory environment, and uptake of abuse-deterrent formulations.
- Companies should incorporate legal and regulatory risks into their pricing and strategic planning.
- Emerging markets may provide higher growth margins but will require navigating local regulatory and reimbursement frameworks.
FAQs
1. How do patent expirations affect the market price of NDC 00173-0643?
Patents on branded formulations expire typically after 20 years, allowing generics to enter the market. This generally causes a significant price reduction, as seen when OxyContin's patent was challenged, leading to increased generic competition and reduced prices.
2. What regulatory changes could impact future pricing?
Stricter abuse-deterrent requirements, tighter prescription guidelines, and legal settlements could decrease prescribing and, consequently, sales volume, pressuring prices downward.
3. How does the legal environment influence market prospects?
Ongoing lawsuits against opioid manufacturers have led to substantial financial settlements. These legal actions may impose restrictions, influence public perception, and impact market profitability.
4. What growth areas exist for oxycodone ER drugs?
Emerging markets with rising healthcare infrastructure and aging populations display potential. Also, companies developing abuse-resistant formulations are likely to command premium pricing.
5. Can the market recover from current downward price trends?
While prices are under pressure, niche products like abuse-deterrent formulations or niche markets with unmet needs could sustain higher prices, preventing complete market collapse.
References
- Statista. (2022). Global opioid analgesic market size.
- U.S. Food and Drug Administration. (2020). Opioid prescribing guidelines.
- IMS Health. (2021). Prescription opioid sales report.
- Law360. (2022). Purdue Pharma opioid settlement details.
- MarketWatch. (2023). Opioid market forecast analysis.
[1] APA citation style used for all references.
