Last updated: February 21, 2026
What is the drug associated with NDC 72578-0094?
NDC 72578-0094 is a commercial product identified as Oxycodone Hydrochloride Extended-Release Tablets, USP. It is a Schedule II controlled substance used for managing moderate to severe chronic pain.
What is the current market landscape for oxycodone extended-release products?
The oxycodone extended-release market is mature, dominated by a few key manufacturers. Major brands include Purdue Pharma's OxyContin, Teva's Oxymorphone ER, and generic versions produced following patent expirations.
Market size and growth trends
- Global analgesics market (2022): USD 31.4 billion.
- North American opioids market: USD 15 billion, driven primarily by prescription opioids for chronic pain.
- Growth rate: Compound annual growth rate (CAGR) of 4% from 2022 to 2027, driven by aging populations and rising chronic pain prevalence.
Key competitive factors
- Brand vs. generic: Generics account for over 60% of sales but face price pressure.
- Regulatory challenges: Increased scrutiny due to opioid crisis impacts distribution and marketing.
- Distribution channels: Distribution through wholesalers, pharmacies, and direct healthcare providers.
Who are the main competitors?
| Product Name |
Manufacturer |
Formulation |
Market Share (estim.) |
Price Range (per tablet) |
| OxyContin |
Purdue Pharma |
Extended-release, 10-80 mg |
~40% |
USD 10 - 30 |
| Xtampza ER |
Purdue Pharma |
Extended-release, abuse-deterrent |
Approx. 10% |
USD 20 - 35 |
| Generic oxycodone ER |
Multiple generics |
10-80 mg |
Approx. 50% |
USD 2 - 10 |
What are the key regulatory considerations?
- Patent status: OxyContin patents expired in 2012. No current patents protect the basic formulations.
- Schedule II status: Tight regulatory controls restrict prescribing, led by CDC guidelines aimed at curbing misuse.
- Abuse-deterrent formulations (ADFs): Increasing adoption reduces diversion but limits market growth for non-ADFs.
What are the pricing trends?
Historical price trends
- Prices per tablet for branded formulations have stabilized or slightly declined over the past five years.
- Generic versions have driven prices down, with some as low as USD 2-5 per tablet.
Future price projections
| Year |
Estimated Price Range (per tablet) |
Notes |
| 2023 |
USD 2 - 30 |
Slight decrease for generics; stable for branded |
| 2024 |
USD 2 - 28 |
Continued generic price pressure |
| 2025 |
USD 2 - 25 |
Market saturation; patent expirations not relevant here |
| 2026 |
USD 2 - 22 |
Marketing shifts towards abuse-deterrent formulations |
| 2027 |
USD 2 - 20 |
Market stabilization, entry of new formulations |
Price influencers
- Regulatory crackdowns reduce prescription volume.
- Insurance coverage influences patient co-payments.
- Manufacturers' strategies include introducing abuse-deterrent products, which typically carry higher prices.
What factors could influence market and price dynamics?
- Policy changes: Stricter prescribing guidelines, inclusion in formularies.
- Epidemiology: Rising opioid misuse could reduce legitimate market size.
- Innovation: New formulations with better abuse-deterrent properties could gain market share.
- Legal risks: Litigation related to opioid epidemic could impact pricing and manufacturing.
Key Takeaways
- The oxycodone extended-release market is mature with a focus on generics and abuse-deterrent formulations.
- Prices for the drug are expected to decline gradually due to generics and regulatory pressures.
- Market growth is constrained by regulatory tightening and shifts toward non-opioid pain management.
- The product's revenue potential depends heavily on distribution dynamics and legal considerations.
- Future profits hinge on regulatory landscape changes and innovations in abuse-deterrent technology.
FAQs
1. How does patent expiration influence pricing for NDC 72578-0094?
Patent expiration allows generic manufacturers to produce lower-cost alternatives, leading to significant price reductions.
2. What role do abuse-deterrent formulations play in market dynamics?
They command higher prices but face a narrowing market as regulations favor non-opioid alternatives.
3. How might changes in regulatory policies impact the market?
Tighter controls lower prescription volumes, reducing total market size but potentially increasing prices of remaining products.
4. What is the typical price range for generic oxycodone ER tablets?
Between USD 2 and USD 10 per tablet, depending on strength and supplier.
5. What segments are most vulnerable to price erosion?
Brand-name formulations with no abuse-deterrent features, especially as generics gain dominance.
References
- MarketWatch. (2022). "Global analgesics market size forecast."
- IQVIA. (2022). "Opioid prescription trends and market share data."
- CDC. (2021). "Guidelines for prescribing opioids."
- FDA. (2020). "Regulations on abuse-deterrent opioids."
- EvaluatePharma. (2022). "Pharmaceutical price trends."
