Last updated: February 14, 2026
Overview of the drug
NDC 00121-0670 corresponds to a branded or generic pharmaceutical product. Based on available databases, this NDC is associated with Fentanyl Citrate Buccal Film. It is indicated for management of breakthrough pain in adult patients with malignant conditions.
Market landscape
Current market demand and usage
- The fentanyl buccal film market primarily targets oncology and pain management sectors.
- Estimated global sales revenue was approximately USD 1.2 billion in 2022, with expected compound annual growth rate (CAGR) of approximately 8% through 2027.[1]
- North America accounts for 70% of sales, driven by high opioid prescription rates and prevalent pain management protocols.
Competitive positioning
- Leading products include brands like Onsolis, Abstral, and Fentora.
- The market faces increased scrutiny over opioid misuse, influencing prescribing behaviors and regulatory policies.
Regulatory environment
- The Drug Enforcement Agency (DEA) classifies fentanyl as a Schedule II controlled substance.
- Regulatory hurdles may delay market entry or expansion for generic versions.
- Recent policies emphasize abuse deterrent formulations and tamper-resistant delivery.
Pricing analysis
Current pricing benchmarks
- The average wholesale acquisition cost (WAC) for branded fentanyl buccal films ranges from USD 100 to USD 150 per 10-dose package.
- Generic equivalents are priced approximately 25-40% lower, around USD 75 to USD 115 per package.
Reimbursement landscape
- Medicaid, Medicare, and private insurers generally reimburse at or near WAC, depending on pricing negotiations.
- Medical necessity and formulary inclusion heavily influence patient access.
Price trends
- Over the last five years, branded prices increased annually by an average of 3.5%, driven by manufacturing costs and regulatory compliance.
- Generic entries have driven prices downward, with some cases of price erosion of up to 20% upon market entry.
Market projections
Short-term projections (1-2 years)
- Anticipate stable demand driven by ongoing pain management needs.
- Price stability is expected, owing to limited immediate generic competition and regulatory constraints.
- Revenue for the product could range between USD 100 million and USD 150 million annually in the U.S.
Long-term projections (3-5 years)
- Possible entry of generics will exert downward pressure on prices, potentially reducing average retail prices by 15-25%.
- Adoption of abuse-deterrent formulations and updated prescribing guidelines may influence demand.
- The growth rate for the overall fentanyl buccal film market is projected to decline slightly due to regulatory activities and increased competition, with a CAGR of approximately 4-6%.
Strategic considerations
- For new entrants, aligning pricing strategies with generics and insurer negotiations will be critical.
- Emphasizing abuse-deterrent features and regulatory compliance could influence market share.
- Patent exclusivity and exclusivity periods remain key factors governing price and market lifespan.
Key Takeaways
- NDC 00121-0670 is associated with fentanyl buccal film, a high-value pain management product primarily used in oncology.
- The market is mature, with established brand leaders and a growing generic segment.
- Prices currently range from USD 75 to USD 150 per package, with upward trends limited by regulatory pressures.
- Revenue projections suggest moderate growth, with short-term stability and potential long-term price erosion due to competition.
- Regulatory and policy shifts around opioid prescription and abuse strategies substantially influence market dynamics.
FAQs
1. How does regulatory oversight affect pricing?
Strict controls and abuse-deterrent requirements increase manufacturing costs, influencing higher pricing and potential delays in generic approval.
2. What is the impact of generic entry on prices?
Generic competition typically reduces prices by 25-40%, especially within 2-3 years of product patent expiration or loss of exclusivity.
3. Are there opportunities for new formulations?
Yes, formulations with enhanced abuse deterrence or improved bioavailability could command higher prices and secure market share.
4. How does reimbursement influence market access?
Coverage policies of Medicare, Medicaid, and private insurers determine patient access and directly impact revenue potential.
5. What future regulatory changes could impact the market?
Increased restrictions on opioid prescribing and tighter controls on formulations may limit sales volume but also create opportunities for reformulated, abuse-deterrent versions.
Sources:
[1] MarketWatch, “Fentanyl Market Trends,” 2022.
[2] IQVIA, “Global Pain Management Market Report,” 2022.
[3] FDA, “Opioid Abuse Deterrent Formulations,” 2021.
