Last updated: February 24, 2026
What Is the Therapeutic Use of NDC 62559-0305?
NDC 62559-0305 corresponds to Buprenorphine Sublingual Film (Brand: Butrans), indicated for the management of pain in adult patients requiring opioid analgesics. It is a partial opioid agonist, providing pain relief while reducing the risk of respiratory depression compared to full agonists.
Current Market Landscape
Market Size and Growth
- The global opioid analgesics market was valued at approximately $15 billion in 2022, with a compound annual growth rate (CAGR) of 4.2% projected through 2030 (Source: Grand View Research[1]).
- Buprenorphine formulations constitute a significant segment within this market, driven by the opioid crisis and a shift toward partial agonists for pain management.
- The U.S. accounts for over 70% of the sales, influenced by prescriber adoption, regulatory policies, and reimbursement policies.
Key Competitors and Market Share
| Product Name |
Formulation |
Approximate Market Share (2022) |
Notable Features |
| Butrans |
Buprenorphine patch |
50% |
Transdermal, long-acting |
| Suboxone |
Buprenorphine + Naloxone |
25% |
Sublingual film, used in addiction treatment |
| Bunavail |
Buprenorphine + Naloxone |
10% |
Buccal film |
| Generic Buprenorphine |
Sublingual tablets/films |
15% |
Cost-effective, rising share |
Regulatory Environment
- FDA approved in 2010 for pain management.
- Schedule III classification limits prescribing to licensed physicians, impacting adoption.
- Recent regulations focus on reducing misuse, affecting formulary inclusion and reimbursement.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per unit |
Notes |
| 2018 |
$8.50 |
Early market entry, relatively stable pricing |
| 2020 |
$9.00 |
Slight increase, market fragmentation begins |
| 2022 |
$10.50 |
Price escalation driven by shortages and increased demand |
Market Drivers for Price Changes
- Manufacturing complexities due to controlled substance regulations.
- Patent exclusivity until 2024, limiting generic competition.
- Increased demand for non-abuse liability formulations.
- Supply chain disruptions inflating costs in 2020-2021.
Projected Pricing (2023-2027)
| Year |
Estimated AWP per unit |
Factors Influencing Price |
| 2023 |
$11.00 |
Patent expiration approaches, potential entry of generics |
| 2024 |
$8.50–$9.50 |
Patent expiry, generic competition begins |
| 2025 |
$7.50–$8.50 |
Increasing generics market penetration |
| 2026 |
$6.50–$7.50 |
Market consolidation, price stabilization |
| 2027 |
$6.00–$7.00 |
Mature generics market, pricing normalization |
Implications for Stakeholders
- Manufacturers: Patent expiry presents short-term revenue risk but opens opportunities for generic pricing.
- Payers: Price reductions expected with increased generic availability.
- Patients: Cost savings anticipated with the entry of lower-cost generics.
- Investors: Demand for branded formulations likely to decline post-2024, shifting focus to generics.
Key Market Trends
- Growing preference for multi-modal pain management reducing reliance solely on opioids.
- Policy shifts toward stricter prescribing guidelines lower market volume growth.
- Increased utilization of abuse-deterrent formulations affecting premium pricing.
Summary
NDC 62559-0305, Buprenorphine Sublingual Film (Butrans), commands premium prices driven by formulation complexity and regulatory barriers. Price is projected to decline from over $10.50 (AWP) in 2022 to approximately $6–$7 with generic competition by 2027. Market share slowed by regulatory and supply chain dynamics but remains significant within the opioid analgesics sector.
Key Takeaways
- Patent expiration in 2024 will likely trigger a price decline of approximately 20–30%.
- The market is consolidating with increased generic penetration, pressuring branded pricing.
- Demand remains steady but faces headwinds due to tighter prescribing regulations.
- Supply chain issues have temporarily inflated prices but are expected to normalize.
- Stakeholders must monitor regulatory policy shifts impacting formulary and reimbursement strategies.
FAQs
1. When does patent protection for Butrans end?
Patent protection expires in 2024, paving the way for generic versions.
2. How might the entry of generics affect pricing?
Generic entry typically reduces prices by 50% or more, depending on market competition and manufacturer pricing strategies.
3. What are the main regulatory barriers impacting this drug’s market?
Schedule III classification limits prescribing authority. Controlled substance regulations influence manufacturing, distribution, and sales.
4. Are there alternative formulations likely to influence pricing?
Yes, transdermal patches, buccal films, and abuse-deterrent formulations impact market dynamics and pricing strategies.
5. How does the current opioid policy environment affect market growth?
Stricter prescribing guidelines and increased oversight hinder growth but bolster demand for safer formulations like buprenorphine.
References
[1] Grand View Research. (2022). Opioid analgesics market size, share & trends analysis. Retrieved from https://www.grandviewresearch.com
