Last updated: April 1, 2026
What is the drug associated with NDC 31722-0381?
NDC 31722-0381 corresponds to Etrasimod, approved by the FDA for the treatment of ulcerative colitis and Crohn’s disease. Etrasimod is a selective sphingosine 1-phosphate receptor modulator, developed by Arena Pharmaceuticals (now part of Pfizer). Its primary indications are inflammatory bowel diseases (IBD).
Market Landscape
Current Market Overview
- Therapeutic Competition: Etrasimod enters a market with established therapies such as mesalamine, corticosteroids, immunomodulators, and biologics (e.g., infliximab, adalimumab).
- Market Size: The global IBD treatment market was valued at approximately $8 billion in 2022 and expected to grow at a CAGR of 6% through 2030, driven by increasing diagnosis rates.
- Key Players:
- AbbVie (Humira)
- Takeda (Entyvio)
- Johnson & Johnson (Stelara)
- Innovative small molecules like ozanimod and etrasimod compete in the oral sphingosine-1-phosphate receptor modulator niche.
Etrasimod’s Unique Position
- Oral administration offers an alternative to injectable biologics.
- Clinical trials show promising efficacy with potentially fewer side effects than some existing treatments.
- FDA approval occurred in March 2023 for ulcerative colitis; Crohn’s disease approval is pending.
Market Penetration Factors
- Pricing: Comparable to other novel oral agents; initial estimates suggest $60,000–$70,000 annually per patient.
- Reimbursement Landscape: Payer acceptance influences market uptake; subscription models for new drugs are emerging.
- Patient Access: Expanded indications and formulary placements will drive wider adoption.
Price Projections
Baseline Price Assumptions (2023–2028)
| Year |
Estimated Wholesale Price (WAC) |
Estimated Net Price |
Market Share |
Expected Revenue |
| 2023 |
$65,000 |
$55,000 |
10% |
$55 million |
| 2024 |
$65,000 |
$55,000 |
20% |
$110 million |
| 2025 |
$65,000 |
$55,000 |
35% |
$192.5 million |
| 2026 |
$65,000 |
$55,000 |
50% |
$302.5 million |
| 2027 |
$65,000 |
$55,000 |
65% |
$402.25 million |
| 2028 |
$65,000 |
$55,000 |
75% |
$517.5 million |
Note: Assumes a stable wholesale acquisition cost (WAC) and net price, with market share growth influenced by competition and clinical adoption.
Factors Influencing Price and Sales
- Market Competition: Existing biologics maintain high prices; obstinate market barriers may limit rapid penetration.
- Cost-Effectiveness: Etrasimod’s oral administration and favorable safety profile may enable premium pricing.
- Regulatory Approvals: Additional indications (Crohn’s disease, others) could expand addressable patient bases.
- Insurance Reimbursement: Payer policies impacting patient access may limit rapid uptake, affecting revenue projections.
Long-term Outlook
- Competition from generic and biosimilar biologics will pressure prices beyond 2028.
- Potential price erosion expected as market matures and more oral S1P receptor agents enter.
Regulatory and Commercial Risks
- Delayed Approvals: Uncertainty around Crohn’s disease approval could limit revenue growth.
- Market Resistance: Clinicians may prefer established biologics initially.
- Pricing Negotiations: Payer pushback or tiered formularies could reduce net revenues.
Key Takeaways
- NDC 31722-0381 (Etrasimod) is positioned in a growing IBD treatment market with advantages over injectables.
- Initial sales are projected to reach approximately $55 million in 2023, scaling to over $500 million by 2028.
- Price points are expected to remain in the $55,000–$65,000 range annually per patient, with potential for variation based on market dynamics.
- Competitive pressures and regulatory developments significantly influence revenue trajectories.
FAQs
1. What is the primary indication for NDC 31722-0381?
Ulcerative colitis, with pending approval for Crohn’s disease.
2. Who are the key competitors to Etrasimod?
Biologics like infliximab, adalimumab, and other small molecules such as ozanimod.
3. What is the target price range for Etrasimod?
$55,000 to $65,000 annually per patient, aligning with current market trends for oral IBD therapies.
4. How does market penetration impact revenue projections?
Higher market share significantly boosts revenue; early adoption and payer acceptance are crucial factors.
5. Will pricing pressure reduce long-term revenues?
Yes, as biosimilars and generics enter, prices are likely to decline, especially beyond 2028.
References
[1] IQVIA. (2022). "Global IBD Market Report." IQVIA Institute for Human Data Science.
[2] FDA. (2023). "FDA approval notices for Etrasimod."
[3] MarketWatch. (2023). "Oral IBD Treatments Market Forecast."
[4] Pfizer. (2023). "Etrasimod prescribing information."
[5] Evaluate Pharma. (2022). "Pharmaceutical Sales Forecasts."
