Last updated: February 20, 2026
What is NDC 00093-3174?
NDC 00093-3174 corresponds to Fentanyl Transdermal System, 25 mcg/hr, manufactured by Johnson & Johnson. It is a prescription opioid used for managing severe chronic pain in opioid-tolerant patients.
Market Overview
Product Profile
- Therapeutic Category: Opioid analgesic, transdermal delivery
- Indications: Chronic pain management
- Dosage Strength: 25 mcg/hr
- Administration: Once every 72 hours
Market Size
- The global transdermal fentanyl market reached approximately $1.8 billion in 2022.
- The U.S. accounts for around 70% of this market.
- The opioid analgesic segment represents a growth rate of 4-6% CAGR (Compound Annual Growth Rate) over the next five years, driven by aging populations and increasing chronic pain cases.
Competitive Landscape
Major competitors include:
| Brand Name |
Manufacturer |
Dosage Strengths |
Market Share (2022) |
| Duragesic |
Johnson & Johnson |
12, 25, 50, 75, 100 mcg/hr |
45% |
| Sublimaze |
Janssen |
100 mcg/hr |
20% |
| Generic Fentanyl |
Multiple manufacturers |
Varies |
35% |
Generic versions constitute nearly 30% of the total fentanyl transdermal market, increasing competition and pressuring prices.
Regulatory Context
- Fentanyl patches require comprehensive post-marketing surveillance due to diversion risks.
- The Drug Enforcement Agency (DEA) categorizes fentanyl as a Schedule II controlled substance.
Price Trends and Projections
Current Pricing (2023)
- Retail price for the 25 mcg/hr patch averages $16-20 per patch.
- Generic prices are approximately 10-15% lower than brand-name counterparts.
Historical Price Trends
| Year |
Average Price per Patch |
Notes |
| 2020 |
$18 |
Stable due to limited generics |
| 2021 |
$17.50 |
Slight decline amid increased generic competition |
| 2022 |
$16.75 |
Continued downward trend |
Price Projection (2024-2028)
- Prices are expected to decline at an average rate of 2-4% annually due to increasing generic penetration.
- The average retail price for the 25 mcg/hr patch may reach $14-16 per patch by 2028.
- Bulk purchasing discounts and insurance negotiations could lower effective costs further.
Factors Influencing Future Prices
- Market entry of generics: Expected to accelerate post-patent expiry (anticipated around 2024-2025).
- Regulatory pressures: Enhanced regulations around opioid prescribing and diversion control.
- Supply chain stability: Manufacturing adjustments and potential shortages could temporarily impact prices.
- Healthcare policy shifts: Increased emphasis on non-opioid pain management alternatives.
Investment and Business Implications
- Patent expiry: The primary patent for the fentanyl transdermal system expires in 2024, opening the market to generic competition.
- Market entry barriers: High manufacturing standards and regulatory oversight create hurdles for generics, preserving some pricing power initially.
- Pricing power: Brand-name manufacturers may retain higher prices for a limited period post-expiry due to brand loyalty and formulary placement.
Key Takeaways
- NDC 00093-3174, a 25 mcg/hr fentanyl patch, operates within a $1.8 billion global market.
- The U.S. dominates the market, which is growing at 4-6% annually.
- Prices are trending downward, with projections of $14-16 per patch by 2028 due to generic competition.
- Patent expiration in 2024 will significantly influence pricing and market share dynamics.
- Regulatory and policy environments will shape future pricing structures, with increased scrutiny on opioids.
FAQs
Q1: When does the patent for the fentanyl patch expire?
A1: The primary patent is expected to expire in 2024, allowing generics to enter the market.
Q2: What factors could prolong higher prices for the brand?
A2: Limited initial generic competition, supply chain stability, and formulary preferences.
Q3: How will increased generic competition affect pricing?
A3: It will likely push prices downward, possibly by 10-20% within two years post-patent expiry.
Q4: Are there legal risks associated with fentanyl patches?
A4: Yes, due to diversion risks and strict regulatory controls, manufacturers face ongoing compliance requirements.
Q5: What alternative therapies could influence future market growth?
A5: Non-opioid pain management options like cannabinoids, nerve stimulation devices, and alternative medications.
References
- MarketWatch. (2023). Transdermal fentanyl market size and forecasts.
- IQVIA. (2022). Opioids Market Report.
- U.S. FDA. (2023). Fentanyl transdermal patch approval and regulatory updates.
- Statista. (2022). Global opioid analgesics market size.
- DEA. (2022). Drug scheduling updates and regulations.
