Last updated: February 15, 2026
Overview of the Drug
NDC 63402-0208 corresponds to the drug Vantrela ER (hydrocodone bitartrate extended-release), produced by Teva Pharmaceuticals. It is an opioid pain reliever approved by the FDA for moderate to severe pain management. The drug is part of a broader class of extended-release opioids facing regulatory scrutiny due to abuse potential.
Market Landscape
- Market Size and Demand: The opioid analgesic market has experienced fluctuations driven by regulatory actions, societal concerns over abuse, and shifts towards alternative pain therapies. The US opioid market was valued at approximately $4.8 billion in 2022 (IQVIA), with a declining trend since 2017 owing to increased regulation and opioid substitute therapies.
- Manufacturers: Teva is among the key producers, competing with brands such as Purdue Pharma (OxyContin), Endo Pharmaceuticals, and other generics manufacturers. Several new formulations aiming to mitigate abuse potential have entered the market.
- Regulatory Environment: The Drug Enforcement Administration (DEA) classifies hydrocodone as a Schedule II controlled substance, influencing prescribing patterns, distribution, and pricing.
Market Penetration and Usage
- Usage has declined approximately 15-20% annually since 2017, reflecting tighter regulations, the rise of abuse-deterrent formulations, and increased adoption of non-opioid alternatives.
- In 2022, approximately 1.2 million prescriptions of hydrocodone extended-release formulations issued in the US (IQVIA).
Pricing and Economic Factors
- Average Wholesale Price (AWP): For Vantrela ER, the AWP was approximately $3.30 per tablet in Q4 2022.
- Average Selling Price (ASP): Discounted to approximately $2.50-$2.80 per tablet after reductions and negotiations.
- Pricing Trends: The price is expected to decline gradually owing to generic competition, with potential stabilization around $2.00-$2.50 per tablet by 2025. Factors influencing pricing include supply chain dynamics, regulatory constraints, and insurance reimbursement policies.
Competitive Pressure
- The patent status for Vantrela ER was lost in 2021, leading to increased generic availability.
- Multiple generics entered the market, resulting in a price erosion of approximately 35-50% over three years.
- Innovations in abuse-deterrent formulations have limited market share due to higher costs and regulatory hurdles.
Price Projections (2023–2027)
| Year |
Estimated AWP per Tablet |
Estimated ASP per Tablet |
Main Influencing Factors |
| 2023 |
$2.50 |
$2.00–$2.50 |
Entry of generics, prescriber shift |
| 2024 |
$2.20–$2.40 |
$1.80–$2.20 |
Increased generic penetration |
| 2025 |
$2.00 |
$1.60–$2.00 |
Market saturation, regulatory pressures |
| 2026 |
$1.80–$2.00 |
$1.50–$1.80 |
Potential policy impacts, reformulations |
| 2027 |
$1.70–$1.90 |
$1.40–$1.70 |
Further generic adoption, market stabilization |
Regulatory and Policy Impact
- The DEA's rescheduling policies and REMS (Risk Evaluation and Mitigation Strategy) programs are set to further restrict prescribing. This constrains revenue growth, potentially lowering prices.
- State and federal initiatives aim to promote alternative pain management therapies, impacting prescriptions for hydrocodone products.
Implications for Stakeholders
- Manufacturers: Pricing is under pressure from generics and regulatory limits. Innovation in abuse-deterrent or abuse-resistant formulations could command premium pricing but face hurdles in approval and market acceptance.
- Investors: Revenue projections suggest declining EBIT margins for marketed formulations; diversification into non-opioid pain management is advisable.
- Healthcare Providers: Prescribing trends favor multimodal pain management, potentially reducing reliance on hydrocodone extended-release formulations.
Key Takeaways
- The market for NDC 63402-0208 is characterized by declining demand due to regulatory, societal, and market factors.
- Price erosion expected to continue, with ASP per tablet declining to approximately $1.60–$2.00 by 2025.
- Competition from generics and reformulations is intensifying, constraining revenue potential.
- Policy shifts aim to limit opioid distribution, influencing future market dynamics.
- Innovation in abuse-resistant formulations may sustain niche pricing but face regulatory and adoption benchmarks.
FAQs
1. What is the primary driver of price decline for NDC 63402-0208?
Generic competition and regulatory constraints reduce pricing by increasing market saturation and curbing prescribing practices.
2. How does regulatory policy influence the market for hydrocodone extended-release drugs?
Policies like DEA scheduling restrictions and REMS programs limit prescribing and dispensing, reducing market size and prices.
3. Are there opportunities for higher pricing in the future?
Limited; unless new formulations with abuse-deterrent features gain approval and market share, price increases are unlikely.
4. How does the trend in opioid prescribing affect the demand for this drug?
Prescriptions are decreasing due to tighter regulations and alternative therapies, decreasing demand and revenue.
5. What alternative therapies could impact the market?
Non-opioid pain medications, nerve blocks, and non-pharmacologic interventions gain popularity, further reducing hydrocodone products' market share.
References
[1] IQVIA. "2022 Pharmaceutical Market Data."
[2] FDA. "Hydrocodone Extended-Release."
[3] DEA. "Controlled Substance Schedules."
[4] Teva Pharmaceuticals. "Product Information."
