Last updated: February 27, 2026
What is NDC 33342-0483?
NDC 33342-0483 refers to Vantrela ER (hydrocodone bitartrate and acetaminophen extended-release tablets), developed by Actavis Pharma. Approved by the FDA in June 2014, it is indicated for pain management, specifically for moderate to severe pain requiring around-the-clock opioid treatment. It is marketed as an alternative to immediate-release formulations.
Market Landscape
Key Players and Competitors
| Company |
Product Name |
Formulation |
Indications |
Market Share (Estimated, 2023) |
| Actavis/Teva |
Vantrela ER |
Hydrocodone/Acetaminophen ER |
Moderate to severe pain |
20-25% |
| Purdue Pharma |
Butrans |
Buprenorphine patch |
Chronic pain, opioid dependence |
10-12% |
| Mallinckrodt |
Embeda |
Hydrocodone/NaCl + Naltrexone |
Chronic pain |
5-8% |
| Other competitors |
Various |
Various |
Various |
60-65% |
Market analysts estimate the US extended-release hydrocodone segment, including Vantrela ER, accounts for approximately $400 million in annual sales (2023). The segment has experienced slow growth due to regulatory scrutiny and shifts toward abuse-deterrent formulations.
Regulatory and Market Trends
-
Regulatory Scrutiny: The opioid market faces increased restrictions. The FDA has emphasized abuse-deterrent features, affecting product development and marketability.
-
Opioid Prescription Trends: There has been a decline in opioid prescriptions over the past five years, with a 25% reduction from 2018 to 2022. This limits growth prospects but stabilizes demand for existing products.
-
Generic Competition: Multiple generics are available, reducing the price point of branded formulations.
Price Projections (2023-2028)
Current Pricing
| Product Name |
Average Wholesale Price (AWP) per unit |
Remarks |
| Vantrela ER 10 mg |
$4.50 |
Per tablet, 30-day supply (~30 tablets) |
| Vantrela ER 20 mg |
$4.50 |
Same as above |
Projected Prices
| Year |
Estimated AWP per tablet |
Market Factors |
Remarks |
| 2023 |
$4.50 |
Current generic competition, moderate demand |
Stable, slight downward pressure |
| 2024 |
$4.20 |
Increased focus on abuse-deterrent formulations, price compression |
Slight decrease expected |
| 2025 |
$3.80 |
Continued generic proliferation, stricter prescribing regulations |
Further decline |
| 2026 |
$3.50 |
Market saturation, emphasis on alternative therapies |
Stabilization at lower prices |
| 2027 |
$3.20 |
Emergence of new abuse-resistant formulations |
Price stabilization |
| 2028 |
$3.00 |
Mature market, high generic penetration |
Slight further decrease |
Assumptions
- No substantial policy shifts or regulatory bans.
- No major patent litigations or exclusivity extensions.
- Continuation of current prescription trends.
- Increased emphasis on abuse-deterrent features marginally affects pricing.
Revenue Forecasts
Estimated US market volume: 3-5 million units annually.
| Year |
Revenue Estimate |
Notes |
| 2023 |
$13.5 million |
Based on 3 million units at $4.50/unit |
| 2024 |
$8.4 million |
Based on 2 million units at $4.20/unit |
| 2025 |
$6.8 million |
Based on 1.8 million units at $3.80/unit |
| 2026 |
$5.6 million |
Based on 1.6 million units at $3.50/ unit |
| 2027 |
$4.8 million |
Based on 1.5 million units at $3.20/ unit |
| 2028 |
$4.5 million |
Based on 1.5 million units at $3.00/ unit |
Key Considerations
- Patent and exclusivity status can alter pricing dynamics if extended or challenged.
- Emerging abuse-deterrent formulations could pressure existing products.
- Healthcare policies promoting non-opioid pain management could further restrict growth.
Key Takeaways
- NDC 33342-0483 (Vantrela ER) faces a declining yet stable market amid increasing regulatory restrictions.
- The segment's overall market value is approximately $400 million annually.
- Price per unit is projected to decline from $4.50 in 2023 to around $3 in 2028.
- Revenue forecasts suggest a gradual decrease correlating with reduced prescription volumes.
- Competition from generics and abuse-deterrent formulations strongly influence price and market share.
FAQs
1. What factors influence the price of Vantrela ER?
Pricing is affected by generic competition, regulatory restrictions, abuse-deterrent features, and prescribing trends.
2. How is market share distributed among competitors?
Actavis/Teva holds an estimated 20-25%, with other players sharing the remainder. Generic products dominate due to lower prices.
3. What regulatory changes could impact this market?
Potential changes include stricter prescribing regulations, approval of abuse-deterrent formulations, and bans on certain opioid formulations.
4. Will demand for Vantrela ER increase?
Demand stabilizes or declines modestly owing to shifting clinical practices away from opioids, but existing demand remains steady for chronic pain management.
5. How does abuse-deterrent formulation development affect pricing?
It can cause market fragmentation, reduce abuse, and pressure older formulations to decrease prices, but may also offer premium pricing if marketed effectively.
References:
[1] IQVIA. "US Prescription Drug Market Data," 2023.
[2] FDA. "Drug Approvals and Labeling," 2014.
[3] MarketWatch. "Opioid Market Trends," 2023.
[4] EvaluatePharma. "Analyses of the Pain Management Segment," 2023.
[5] U.S. Department of Health and Human Services. "Opioid Prescribing Trends," 2022.
