Last updated: February 22, 2026
What is the Drug Identified by NDC 61314-0126?
NDC 61314-0126 refers to Zynrelef (bupivacaine and dexamethasone), approved by the FDA in August 2020. It is a local anesthetic used for pain management in surgical settings.
Market Landscape Overview
Zynrelef targets the post-operative analgesia market, which is projected to expand due to increased surgical procedures and opioid-sparing pain management strategies.
Indications and Competitive Position
- Indications: Surgical pain control, primarily in intraoperative and postoperative settings.
- Competitors: Several local anesthetics, including bupivacaine formulations (e.g., Exparel) and multi-modal pain management approaches.
- Differentiators: Combines local anesthetic with corticosteroid to prolong pain relief; FDA approval in intra-articular and nerve block applications.
Market Size and Trends
- The global regional anesthesia market was valued at approximately USD 2.8 billion in 2022.
- Compound annual growth rate (CAGR): about 8% from 2023 to 2030.
- Surgical volume growth, especially in orthopedic, cardiovascular, and obstetric procedures, drives demand.
- Preference shifts toward opioid-sparing options bolster uptake of extended-release formulations like Zynrelef.
Key Stakeholders
- Manufacturers: Heron Therapeutics (original developer), plus potential generic entrants post patent expiry.
- Healthcare Providers: Hospitals and outpatient surgical centers.
- Payers: Insurance companies, Medicare, Medicaid influence adoption pricing.
Regulatory and Market Access Factors
- FDA approval expands potential usage in multiple surgical indications.
- Patent status: Patent protection extends until 2030, delaying generics.
- Reimbursement: Premium pricing justified by added clinical benefits; CMS and private payers are evaluating coverage policies.
Price Projections and Cost Analysis
Current Pricing
- Brand Name (Zynrelef): Approximately USD 600-800 per dose, depending on administration route and geographic region.
- Disposables and administration costs: Additional USD 100-200.
- Comparison with Competitors:
- Exparel (~USD 300-400 per dose)
- Other local anesthetics (~USD 50-200 per dose)
Future Price Trends (2023–2028)
| Year |
Estimated Price Range |
Key Drivers |
| 2023 |
USD 600 – 800 |
Established market presence, initial adoption costs |
| 2024–2025 |
USD 550 – 750 |
Competitive pressure from generics, value-based care initiatives |
| 2026–2028 |
USD 500 – 700 |
Increased generic competition, cost-conscious payers |
Price Sensitivity and Adoption Factors
- Increased adoption expected as clinical benefits demonstrate reduction in hospital stay and opioid use.
- Payer negotiations may reduce list price by 10-20% over five years.
- Use in outpatient settings will likely further pressure prices downward.
Revenue and Market Penetration Scenarios
| Scenario |
Adoption Rate (2028) |
Revenue Estimate (USD millions) |
Assumptions |
| Conservative |
20% of target procedures |
USD 300 |
Based on slow adoption, generic competition |
| Moderate |
40% of target procedures |
USD 600 |
Based on accelerated uptake, broader indications |
| Aggressive |
60% of target procedures |
USD 900 |
Rapid market penetration, premium pricing maintained |
Key Considerations for Stakeholders
- Patent protection supports premium pricing through 2030.
- Entry of generics post-patent expiry could reduce prices by 50% or more.
- Expanding indications and formulary inclusion will influence volume and revenue.
- Cost reductions via manufacturing efficiencies will impact pricing strategies.
Conclusion
Zynrelef's market is poised for growth driven by surgical volume increases and demand for opioid-sparing protocols. Its pricing remains premium initially, with potential declines as competition and generics enter the market.
Key Takeaways
- The drug is positioned in a growing post-op pain management segment.
- Current prices are USD 600-800 per dose with expectations of gradual declines.
- Market expansion depends on healthcare provider adoption, payer coverage, and regulatory developments.
- Patent protections until 2030 support sustained premium pricing.
- Generic competition will likely reduce prices by 50% post-patent, impacting revenues.
FAQs
1. How does Zynrelef compare to similar drugs in efficacy?
Zynrelef provides prolonged anesthesia due to its combination of local anesthetic and corticosteroid, with studies indicating superior pain control durations compared to traditional bupivacaine formulations.
2. When are generics expected to enter the market?
Generic versions could appear around 2030 once patent protections expire, potentially halving current prices.
3. What factors influence reimbursement levels?
Reimbursement depends on clinical benefit documentation, hospital policies, and payer negotiations. Evidence supporting opioid reduction and LOS decrease favors higher reimbursement levels.
4. What is the potential for off-label uses?
Limited off-label applications exist but are generally less commercialized due to lack of formal approval for those indications.
5. How might future regulatory changes impact prices?
Policy shifts toward value-based care and stricter price controls could pressure prices downward, especially post-patent expiry.
References
[1] U.S. Food and Drug Administration. (2020). Zynrelef (bupivacaine and dexamethasone) injection. FDA Database.
[2] MarketWatch. (2023). Global regional anesthesia market size and forecast.
[3] Heron Therapeutics. (2020). Zynrelef product monograph.
[4] IQVIA Institute. (2022). The Growth of Surgical Procedures and Pain Management Trends.
