Last updated: March 8, 2026
What is the drug associated with NDC 00046-1102?
NDC 00046-1102 corresponds to Oxycodone Hydrochloride Extended-Release Tablets, 10 mg. This medication contains oxycodone, a Schedule II opioid used mainly for managing moderate to severe pain.
What is the current market landscape?
Market size and usage
- The extended-release oxycodone market is a segment within the broader opioid analgesic market.
- The global opioid analgesics market was valued at approximately USD 15.2 billion in 2022 and expected to grow at a CAGR of 4.8% through 2030.[1]
- The U.S. accounts for around 70% of global opioid sales, driven by high prescription rates and chronic pain prevalence.
Competitive landscape
Top manufacturers include Purdue Pharma, Teva Pharmaceuticals, Mylan, and Acura Pharmaceuticals. Purdue's OxyContin was historically dominant but has seen market share decline due to regulatory actions and increased generic formulations.
Regulatory environment
- The Drug Enforcement Administration (DEA) classifies oxycodone as a Schedule II substance.
- Efforts to curb opioid misuse influence formulary decisions and prescribing behaviors.
Patent and exclusivity status
- Original patents expired around 2013.
- Remaining exclusivity for certain formulations may extend patent protections or data exclusivity periods, but generic competition dominates the market.
What is the price trend for this drug?
Current pricing
- Average wholesale price (AWP) for 10 mg extended-release oxycodone tablets: approximately USD 0.50–0.70 per tablet.[2]
- Retail prices vary significantly based on pharmacy, insurance, and manufacturer discounts.
Price comparison to generics
- Brand-name formulations like OxyContin historically had premium pricing (~USD 2–3 per tablet).
- Generics have driven prices down, offering a 25–70% reduction.
Patent and market entry impact
- Patent expiration led to increased generic availability, reducing prices.
- No recent new formulation patents or major reformulations (e.g., abuse-deterrent versions) have significantly altered pricing dynamics.
What are projections for future pricing?
Short-term outlook (next 1-2 years)
- Prices for 10 mg extended-release oxycodone are expected to stabilize or decline slightly due to increased generic competition.
- Wholesale prices may average USD 0.45–0.65 per tablet, reflecting modest downward pressure.[3]
Long-term outlook (3-5 years)
- Any introduction of abuse-deterrent formulations or combination products could temporarily elevate prices.
- Broader opioid regulation, formulary restrictions, and shifts towards non-opioid pain management could decrease demand, impacting prices adversely.
- Expected price decline of about 10–15%, aligning with trends in generic opioid markets, barring regulatory or litigation shifts.
What factors could influence future market conditions?
- Regulatory crackdowns on opioid prescribing.
- Litigation outcomes against manufacturers.
- Development of alternative pain therapies or non-opioid formulations.
- Market entry of novel abuse-deterrent formulations, which could maintain premium pricing temporarily.
- Changes in Medicare and insurance formulary policies favoring lower-cost generics.
Key Takeaways
- The drug identified under NDC 00046-1102 is a 10 mg extended-release oxycodone tablet, competing mainly with generic versions.
- The market size is substantial but declining due to increased regulation and alternative therapies.
- Current prices are approximately USD 0.50–0.70 per tablet; prices have decreased significantly since patent expirations.
- Future prices are likely to trend downward, with minor fluctuations based on regulatory, legal, and technological factors.
- Industry consolidation, litigation, and policy changes pose significant risks to the market's stability and pricing.
FAQs
1. Will the price of NDC 00046-1102 increase again?
Unlikely in the near term. Prices are stable or declining due to generic competition and regulatory pressures.
2. Are there any new formulations that could alter the market?
Abuse-deterrent and combination products have been developed but currently hold limited market share; their higher prices could influence future price trends temporarily.
3. How does regulation affect the price?
Stricter prescribing guidelines and legal actions could reduce demand, applying downward pressure on prices.
4. Is there significant geographic variation in prices?
Yes. U.S. prices tend to be higher than international markets due to regulatory, patent, and market factors.
5. What is the forecast for the opioid market overall?
The market will likely contract due to increased regulation and alternative therapies, with a compound annual decline expected over the next five years.
References
[1] Market Research Future. (2023). Global Opioid Analgesics Market Forecast to 2030.
[2] First Databank. (2023). Drug Pricing Sources.
[3] IQVIA. (2023). National Prescription Audit and Market Trends Data.
