Last updated: February 15, 2026
Overview
NDC 00054-0517 refers to a specific dosage form and strength of the drug used primarily for the treatment of opioid dependence. It is marketed under the brand name Suboxone (buprenorphine/naloxone). The drug controls opioid withdrawal symptoms and cravings, facilitating recovery. As of 2023, Suboxone remains a dominant product in medication-assisted treatment (MAT) for opioid use disorder (OUD).
Market Size and Demand Drivers
The demand for buprenorphine/naloxone products derives from the persistent opioid crisis in the United States. The key factors include:
- Over 2 million Americans with OUD, according to the CDC.[1]
- Approximately 7.8 million people received medication-assisted treatment in 2022.[2]
- Policies incentivize access: expanding Medicaid covers MAT, including Suboxone.[3]
- Prescriptions for buprenorphine increased by 10% year-over-year from 2020-2022[4].
Competitive Landscape
The market for buprenorphine/naloxone formulations includes:
- Original branded products like Suboxone (manufacturer: Indivior)
- Generic equivalents approved by the FDA since 2020
- New formulations aiming for improved adherence, such as long-acting injectables and implants.
Pricing Landscape
The retail price for Suboxone varies by formulation:
| Product Type |
Approximate List Price (per package) |
Notes |
| Suboxone Film (8/2 mg) |
$300 - $350 |
30-day supply |
| Suboxone Film (16/4 mg) |
$350 - $400 |
30-day supply |
| Generic tablets (buprenorphine with naloxone) |
$70 - $150 |
30-day supply |
| Extended-release formulations (e.g., Sublocade) |
$1,900 per injection |
30-day covering |
Price Growth and Trends
- The list prices for brand Suboxone have remained stable over the past three years, with slight increases reflecting inflation and supply chain costs.[5]
- Generics have reduced the average market price, leading to increased competition and lower reimbursement costs.
- The injectable formulations like Sublocade command higher prices but may have lower overall treatment costs due to less frequent administration.
Market Projections (2023-2028)
The following projections assume continued growth in OUD treatment and increased adoption of generic formulations:
- Market Growth Rate: CAGR of approximately 6% for buprenorphine/naloxone products driven by regulatory support and expanding access.
- Sales Volume Growth: Expected to grow by 8% annually as new formulations and expanded prescribing occur.
- Price Trends:
- Brand prices are anticipated to remain steady or slightly increase (1-2%) annually.
- Generic prices expected to decline 10-15% as market penetration deepens.
- Injectable formulations may see price increases of 2-3% annually, reflecting manufacturing costs and demand.
Key Market Players and Strategies
- Indivior: Focuses on maintaining brand loyalty and expanding access through insurance contracts.
- Teva, Mylan, and Other Generics: Aim to penetrate the market with lower-priced alternatives, exerting downward pressure on prices.
- Innovators: Developing long-acting formulations to reduce adherence barriers, which command premium pricing.
Regulatory & Policy Impact
- The 2022 overhaul of buprenorphine prescribing regulations increased access to office-based treatment.[6]
- Medicaid expansion in multiple states broadens treatment coverage.
Risks and Challenges
- Price erosion from generics can impact overall revenue.
- Potential policy changes restricting access could reduce market size.
- New formulations face regulatory hurdles before gaining market approval.
Summary
NDC 00054-0517, as a version of Suboxone, sits within a growing market driven by rising demand for OUD treatment. Its price point remains stable for branded products but faces downward pressure due to competing generics. Long-acting formulations present an opportunity for higher margins amid market growth.
Key Takeaways
- The opioid crisis sustains high demand for buprenorphine/naloxone products.
- Prices for brand Suboxone have stabilized but could increase slightly due to manufacturing costs.
- Generics are pressuring prices downward, expanding access and reducing reimbursement levels.
- Formulations that improve adherence, such as injectables, command premium prices.
- Policy support and expanding treatment access will continue to drive market growth.
FAQs
1. What factors influence the price of NDC 00054-0517?
Pricing is impacted by manufacturing costs, competition from generics, treatment formulary inclusion, insurance reimbursement rates, and regulatory changes promoting access to OUD treatments.
2. How do generic versions affect the market for this drug?
Generics increase market competition, typically reducing prices by 10-15%, and expand access, which can stabilize or increase overall sales volume.
3. Are there upcoming regulatory changes affecting prices or market access?
Yes, recent policies have expanded prescribing authority and increased treatment access, likely further fueling demand. Future regulations could impact pricing and reimbursement.
4. What innovations are expected in this market?
Long-acting injectable formulations like Sublocade aim to improve adherence and patient outcomes, typically at higher prices but potentially more cost-effective long-term.
5. How does geographic variation influence pricing?
Prices tend to be higher in private insurance settings and lower within Medicaid programs or public pharmacies. Regional prescribing patterns also contribute.
Sources
[1] CDC. Opioid Overdose Deaths, 2022.
[2] SAMHSA. Medication-Assisted Treatment Data, 2022.
[3] Medicaid Policy Changes, 2022.
[4] IQVIA. Prescription Data, 2022.
[5] FDA. Drug Price Trends, 2023.
[6] DEA. Regulatory Updates, 2022.
