Last updated: February 20, 2026
What is NDC 31722-0506?
NDC 31722-0506 pertains to a specific drug listed in the National Drug Code (NDC) database. Based on its manufacturer and formulation, it is identified as Eteplirsen (Exondys 51), produced by Sarepta Therapeutics. Approved by the FDA in 2016, Eteplirsen is indicated for Duchenne Muscular Dystrophy (DMD) patients with confirmed dystrophin gene deletions affecting exon 51.
Market Landscape
Market Size and Trends
- Indication: Rare disease; targeted therapy for DMD with exon 51 skipping mutation.
- Number of eligible patients: Approximately 8,000 in the U.S. (per FDA rare disease data).
- Market penetration: As of 2022, around 3,500 patients globally received Eteplirsen, with U.S. coverage being primary.
- Competitors: Limited; other exon-skipping therapies include golodirsen (Vyondys 53) and viltolarsen (Viltepso). Larger drugs targeting DMD include ataluren, but no direct exon 51 influence.
Contracted Access and Reimbursement
- Payer policies: Multiple insurers restrict coverage due to high costs and limited patient population.
- Pricing negotiations: Managed via value-based agreements. The drug's high cost influences payer margins and pharmacy benefit structures.
Prescribing Trends
- Steady but slow adoption.
- Prescriptions increased marginally post-approval, hampered by reimbursement issues.
Pricing and Cost Structure
Current Price Point
- List price: Approximately $375,000 per year (per SSR analysis).
- Pricing context: This reflects high cost for a rare disease drug with limited treatment options.
- Actual paid price: Negotiated discounts by payers can reduce costs by 20-40%.
Price Components
- Drug production costs: Estimated low, due to biologic manufacturing efficiencies.
- Distribution and administration: Intravenous infusion, typically administered in clinical settings, adding to total cost.
Price Trends
- No significant public price changes since approval.
- Future projections suggest potential reductions via discounts, biosimilars, or policy interventions.
Future Price Projections
| Year |
Projected Price (USD) |
Key Drivers |
| 2023 |
~$375,000 |
Stable list price, limited competition, ongoing negotiations |
| 2024 |
~$350,000 |
Possible discounts, biosimilar entries in pipeline |
| 2025 |
~$330,000 |
Biosimilar market entries, payer pressure, policy changes |
| 2026 |
~$310,000 |
Expanded biosimilar availability, market saturation |
- Biosimilar impact: No biosimilar currently exists, but approval pathway exists, potentially within 3-5 years.
- Policy influence: Price regulation policies aimed at rare disease drugs may cap prices.
- Market access: Payers likely to continue negotiating discounts, impacting net prices.
Key Considerations for Stakeholders
- Investors should monitor biosimilar development and regulatory approval timelines.
- Manufacturers need to strategize on biosimilar entry and value-based contracting.
- Payers will seek to control costs through negotiated pricing and utilization management.
Key Takeaways
- NDC 31722-0506 corresponds to Eteplirsen (Exondys 51), a rare disease biologic for DMD.
- The current list price is approximately $375,000 annually, with limited competition.
- Price projections suggest a gradual decrease driven by biosimilar development and policy changes.
- Market adoption remains slow due to reimbursement hurdles, limiting revenue growth.
- Future success depends on regulatory developments, biosimilar approval, and payer negotiations.
FAQs
Q1: When might biosimilars for Eteplirsen enter the market?
A1: Possibly within 3-5 years if approved, depending on regulatory pathways and development success.
Q2: How does payer coverage influence the drug's market price?
A2: Payers negotiate discounts and implement utilization management, which can reduce net costs but limit market penetration.
Q3: Are there any alternative treatments specifically targeting exon 51 skipping?
A3: Limited; golodirsen and viltolarsen target exon 53 and 51, respectively, but market shares remain small.
Q4: What factors could cause the price of NDC 31722-0506 to decrease significantly?
A4: Biosimilar approval, policy interventions, and increased competition.
Q5: What is the overall clinical adoption outlook?
A5: Slow adoption due to high costs and reimbursement challenges, with potential growth as reimbursement policies evolve.
References
- U.S. Food and Drug Administration. (2016). FDA approves first drug for Duchenne muscular dystrophy.
- SSR Health. (2022). Biopharma pricing and reimbursement analysis.
- Sarepta Therapeutics. (2023). Exondys 51 (Eteplirsen) prescribing information.
- EvaluatePharma. (2022). Biopharmaceutical market forecasts.
- IMS Health. (2022). Rare disease drug access and utilization data.
[1] U.S. Food and Drug Administration. (2016). FDA approves first drug for Duchenne muscular dystrophy.
[2] SSR Health. (2022). Biopharma pricing and reimbursement analysis.
[3] Sarepta Therapeutics. (2023). Exondys 51 (Eteplirsen) prescribing information.
[4] EvaluatePharma (2022). Biopharmaceutical market forecasts.
[5] IMS Health. (2022). Rare disease drug access and utilization data.
