Last updated: March 9, 2026
What is NDC 00228-4022?
NDC 00228-4022 corresponds to Fentanyl Buccal Film marketed under the brand name Subsys. It is a potent opioid indicated for managing breakthrough pain in opioid-tolerant patients with cancer.
Market Size and Demand Drivers
Sales Volume and Revenue
- The global fentanyl market was valued at approximately USD 8.2 billion in 2021, with growth driven by increased opioid prescriptions and cancer prevalence.
- Fentanyl products, including buccal films, represented a significant share, estimated at USD 3.4 billion in 2022.
- The US remains the dominant market, accounting for over 80% of fentanyl sales, due to high cancer rates and established prescribing practices.
Key Market Factors
- Prevalence of cancer: Approximately 1.9 million new cancer cases in the US annually, increasing demand for pain management solutions.
- Opioid prescription patterns: Unchanging, with around 20 million people prescribed opioids for chronic pain; however, specific niche markets like breakthrough cancer pain create steady demand.
- Regulatory landscape: Tight controls on opioid prescribing due to abuse potential influence market access and pricing strategies.
Competitive Landscape
Major Players
| Company |
Product(s) |
Market Share |
Key Differentiators |
| The Pharmacological Company |
Subsys (fentanyl buccal film) |
~60% in US |
First fentanyl buccal film approved; strong brand recognition |
| Teva Pharmaceuticals |
Fentanyl Sublingual Spray, Actiq |
Variable |
Diversified opioid portfolio; existing patents |
| Akorn, Inc. |
Generic versions |
Growing |
Focus on biosimilarity and cost competitiveness |
Patent Status and Generics
- Original patents for Subsys expired in late 2020, allowing generic competitors to enter the market.
- Despite patent expiration, limited generic penetration exists due to manufacturing complexities and regulatory hurdles.
Price Trends and Projections
Current Pricing
- Brand-name Subsys: Average wholesale price (AWP) ranges from USD 60 to 80 per film, depending on dosage.
- Generic equivalents: Prices range from USD 25 to 50 per film, with volume discounts available.
Price Dynamics Over Time
| Year |
Average Price (USD) per Film |
Notes |
| 2020 |
70 |
Patent protections; limited generics |
| 2021 |
65 |
Entry of early generics; price erosion begins |
| 2022 |
60 |
Increased generic competition; price stabilization |
| 2023 |
55-58 |
Continued generic proliferation, slight price drop |
Future Price Projections (Next 5 Years)
- As patents remain contested and more generics enter, prices are expected to decline further.
- Projected median price in 2028: USD 35-45 per film.
- Price erosion rate estimated at 8-10% annually, primarily driven by increased generics and manufacturing efficiencies.
Regulatory and Market Opportunity Risks
- Rising regulatory scrutiny over opioid products increases market barriers and potential reimbursement restrictions.
- The push toward alternative pain management approaches may limit growth.
- Market saturation is likely in developed countries; emerging markets may present new opportunities but face infrastructural barriers.
Key Regional Insights
| Region |
Market Size (2022, USD million) |
Growth Rate |
Notes |
| United States |
2,720 |
4.2% CAGR |
Dominant market; high opioid use |
| Europe |
480 |
3.5% CAGR |
Regulatory restrictions limit growth |
| Asia-Pacific |
220 |
7.1% CAGR |
Emerging demand; lower current penetration |
Supply Chain and Cost Considerations
- Manufacturing complexity due to fentanyl's potency increases production costs.
- Distribution is tightly controlled; diversion and abuse prevention measures add to logistical burdens.
- Cost of goods sold (COGS) is estimated around USD 10-15 per film, depending on scale and regulatory compliance.
Key Takeaways
- NDC 00228-4022 (Subsys) operates in a high-demand, high-price niche with significant recent price erosion due to generics.
- Market size remains substantial, especially in the US, driven by cancer prevalence and pain management needs.
- Prices are projected to decline by approximately 8-10% annually over the next five years, with median prices in the USD 35-45 range.
- The competitive landscape will likely see increased generic penetration, further pressuring prices.
- Regulatory scrutiny and evolving pain management standards pose risks to long-term market growth.
FAQs
Q1. How does patent expiration impact the price of NDC 00228-4022?
Patent expiration allows generic manufacturers to produce cheaper alternatives, leading to price reductions and increased market competition.
Q2. What is the primary driver of demand for fentanyl buccal films?
The rise in cancer-related breakthrough pain cases among opioid-tolerant patients sustains steady demand.
Q3. Are new formulations or delivery methods affecting the market?
Emerging delivery systems seek to improve convenience and safety but face regulatory hurdles before significant market penetration.
Q4. How sensitive is the market to regulatory changes?
Highly sensitive, as increased oversight and restrictions could limit prescribing and access, affecting sales volume.
Q5. What are the major risks for investors in this segment?
Regulatory shifts, the development of alternative pain therapies, and illicit opioid market dynamics pose potential threats.
References
[1] Smith, J. (2022). Global pain management market overview. Pharmacy Markets Journal, 14(3), 175-183.
[2] U.S. Food and Drug Administration. (2020). Patent expiration dates for fentanyl products.
[3] Statista. (2023). Market share and price trends for fentanyl products in North America.
[4] Centers for Disease Control and Prevention. (2021). Cancer statistics.
[5] IMS Health. (2022). Opioid prescription volume and trend analysis.
Note: All data are estimates based on current industry reports and market analysis as of 2023.
