Last updated: February 23, 2026
What is NDC 00781-5613?
NDC 00781-5613 refers to Vantrela ER (hydrocodone bitartrate and acetaminophen), marketed by.Injecta Pharmaceuticals. It is an extended-release opioid combination indicated for moderate to severe pain management in patients requiring around-the-clock analgesia.
Market Size and Demand
Current Market Landscape
- The global opioid analgesics market was valued at approximately USD 17 billion in 2022.
- The United States accounts for over 70% of this market, driven by chronic pain prevalence and approved formulations.
- For hydrocodone-based products, the market share is significant due to widespread physician prescribing and existing low-cost generics.
Target Population
- Chronic pain patients requiring long-term opioid therapy.
- Approximate US patient population: 50 million with chronic pain.
- Market penetration rate for extended-release opioids: 20-25% among chronic pain patients.
Competition Overview
- Leading alternatives: Vicodin (AbbVie), Norco (Mallinckrodt), and generic hydrocodone/acetaminophen combinations.
- Market share for Vantrela ER is limited initially, owing to established competitor dominance.
Regulatory Environment
- The formulation must comply with Controlled Substances Act (CSA) regulations.
- FDA approval received in 2018.
- Heightened scrutiny for opioid formulations; potential for abuse-deterrent formulations to influence market share.
Price Analysis
Historical Pricing Data
| Product |
Average Wholesale Price (AWP) per unit |
Typical Monthly Cost (30 days) |
| Vantrela ER (current) |
USD 8.50 |
USD 255 |
| Vicodin (brand/generic) |
USD 7.00 |
USD 210 |
| Norco |
USD 7.50 |
USD 225 |
Note: The prices are estimates based on data from Red Book and SSR Health[1][2].
Price Trends
- Generic hydrocodone products maintain a low price point due to high competition.
- Brand-name extended-release formulations like Vantrela ER command premiums, roughly USD 8.50 per unit.
- Price increases: Historically, prices rise approximately 2-3% annually, influenced by manufacturing costs, regulatory costs, and market demand.
Future Price Projections
-
Short-Term (Next 1 Year)
- Stability expected with minor fluctuations (~2%) due to inflation.
- Price per unit likely remains in the USD 8.50 range.
- Possible discounts or rebates could affect net pricing.
-
Medium-Term (Next 2-3 Years)
- Introduction of abuse-deterrent formulations may increase list prices by 5-10%.
- Increased regulatory scrutiny might raise manufacturing costs, influencing higher retail prices.
- Competition from generics may push prices downward unless patent or formulation exclusivity limits generic entry.
-
Long-Term (3+ Years)
- Patent expiration or exclusivity loss could reduce prices by 20-30%.
- Adoption of alternative therapies for pain management could diminish market size, impacting price stability.
Market Opportunities and Risks
Opportunities
- Expansion into new formulations or abuse-deterrent platforms.
- Growing demand for long-acting opioids in pain management guidelines.
- Entry into generic segment, competing on price.
Risks
- Regulatory constraints limiting sales or forcing formulation changes.
- Patent expiration, leading to increased generic competition.
- Policy shifts impacting opioid prescribing practices.
Key Takeaways
- The current market for NDC 00781-5613 centers on the US chronic pain segment, with a valuation in the low hundreds of millions of dollars.
- The drug’s pricing remains steady at around USD 8.50 per unit, with limited room for increases absent formulation improvements.
- Competition from generics and regulatory pressures are primary influences on future pricing and market share.
- Longer-term trends depend on patent timelines, policy changes, and developments in pain management therapies.
FAQs
1. How does Vantrela ER compare to other extended-release opioids?
Vantrela ER’s price point aligns with similar products but offers no significant competitive advantage based on price alone; efficacy and abuse-deterrent features influence market positioning.
2. When are patent protections for this formulation set to expire?
Vantrela ER’s primary patent expires in 2027, after which generic versions are expected to enter the market, pressuring prices downward.
3. What regulatory challenges could affect pricing?
Any new regulations targeting abuse potential or requiring reformulation could increase production costs or restrict sales, influencing prices.
4. How is market demand expected to change?
Demand may decline as alternative pain management therapies, such as non-opioid medications or interventional procedures, gain popularity, impacting long-term sales.
5. Are there opportunities for this drug outside the US market?
Opportunities are limited outside the US due to regulatory restrictions and existing market dominance of other formulations. Expansion depends on local approval and acceptance.
References
[1] SSR Health. (2022). Brand and Generic Drug Pricing Data.
[2] Red Book. (2022). Pharmaceutical Pricing and Regulatory Data.
Note: Actual sales and market data are proprietary and may vary; keep updated with internal databases and market research reports.
