Last updated: March 13, 2026
What is the current status of NDC 55111-0611?
NDC 55111-0611 is a drug marketed by Purdue Pharma. It is indicated for the treatment of opioid dependence. This specific formulation is a 8-week, subcutaneous, extended-release injection of buprenorphine.
Market Size and Demand
Current Market Size
- The global opioid dependence treatment market was valued at $2.5 billion in 2021.
- North America accounted for 75% of the market, driven by high opioid addiction rates and strong healthcare infrastructure.
- The U.S. represents approximately 90% of the North American market, with an estimated sales volume of 1 million prescriptions annually for buprenorphine formulations.
Current Usage
- Buprenorphine-based therapies hold a 70% market share in opioid dependence treatments.
- Prescription figures: approximately 1.2 million prescriptions in the U.S. in 2022.
- Market growth rate: roughly 7% annually, driven by increasing addiction rates and expanded approval for new formulations.
Competitive Landscape
- Main competitors include Suboxone (combination of buprenorphine and naloxone), Sublocade, and Campral.
- Sublocade (Hoffmann-La Roche) is a direct competitor with similar extended-release properties, holding an estimated 60% of buprenorphine injection sales.
- Pricing competitiveness is a key driver of market share, with Suboxone generics offering lower-cost options.
Price Analysis
- Wholesale acquisition cost (WAC):
- Sublocade: approximately $1,200 per month.
- NDC 55111-0611's average WAC: estimated $950 per injection.
- Patient out-of-pocket costs vary based on insurance, but typically range from $50 to $150 per administration.
Pricing Trends
- Price inflation has been minimal over the last five years, with a compound annual growth rate (CAGR) of about 2-3%.
- Generics and biosimilars influence pricing downward pressure, particularly for combination products.
Regulatory and Market Access Factors
- FDA approval for NDC 55111-0611 was obtained in 2019.
- Insurance coverage is generally favorable, with many plans covering extended-release buprenorphine.
- Medicaid and Medicare Part D include coverage, reducing patient cost barriers in the U.S.
5-Year Price Projection
| Year |
Estimated Average WAC per Injection |
Market Growth Rate |
Overall Revenue Projection |
| 2023 |
$950 |
7% |
$950 million (assuming 1 million doses) |
| 2024 |
$985 |
7% |
$1.05 billion |
| 2025 |
$1,020 |
6% |
$1.12 billion |
| 2026 |
$1,055 |
6% |
$1.19 billion |
| 2027 |
$1,090 |
5% |
$1.25 billion |
Note: These projections assume stable market share with minimal price increases, influenced by a competitive landscape and healthcare policies.
Key Takeaways
- The drug faces limited competition in its niche but must contend with generics and biosimilars.
- Price stability is expected, with moderate growth driven by increased adoption.
- The market is poised to expand as opioid dependence treatment becomes a higher priority for healthcare systems globally.
- Pricing strategies should consider insurance coverage and out-of-pocket costs to maximize uptake.
Frequently Asked Questions
1. How does NDC 55111-0611 compare to competing therapies?
It offers extended-release delivery, reducing dosing frequency, which can improve adherence compared to daily oral therapies like Suboxone. Its pricing is higher than generics but lower than some other extended-release injectables.
2. What factors influence the drug’s market penetration?
Insurance reimbursement policies and prescriber familiarity primarily drive uptake. Pricing relative to competitors and patient out-of-pocket costs also impact demand.
3. Are there upcoming regulatory changes that could affect the market?
Potential FDA policy shifts favoring abuse-deterrent formulations or expanded indications could influence market dynamics. No significant changes are currently announced.
4. What is the potential for international expansion?
Limited currently; regulatory and reimbursement barriers vary across countries. Market appetite is growing in Europe and Australia but requires approval and tailored pricing strategies.
5. How might patent expirations affect pricing?
While NDC 55111-0611 is protected by patents until 2025, biosimilar developments could emerge, exerting downward pressure on prices.
References:
[1] MarketWatch. (2022). Opioid dependence treatment market report.
[2] IQVIA. (2022). Prescription drug market data for buprenorphine formulations.
[3] FDA. (2019). Approval announcement for NDC 55111-0611.
[4] Statista. (2023). Global opioid dependence treatment market size.
[5] Centers for Medicare & Medicaid Services. (2022). Coverage policies for opioid dependence treatments.
