Last updated: February 13, 2026
Overview of NDC 66993-0136
NDC 66993-0136 corresponds to Etrasimod, an oral sphingosine 1-phosphate (S1P) receptor modulator developed by competing pharmaceutical companies. It targets immune modulation for conditions such as ulcerative colitis and Crohn’s disease.
Market Context
Etrasimod positions itself within the inflammatory bowel disease (IBD) treatment space, competing primarily with drugs like Pfizer’s Xeljanz (tofacitinib) and Takeda’s Entyvio (vedolizumab). Its mechanism offers a potentially improved safety profile versus biologics, emphasizing oral administration and targeted immune regulation.
Regulatory Status
- As of December 2022, Etrasimod received FDA breakthrough therapy designation for ulcerative colitis.
- Phase 3 trials are ongoing, with potential NDA submission expected within 12-18 months.
- Regulatory approval timelines heavily influence near-term market access strategies and pricing.
Market Size and Growth Projections
| Item |
Data |
Source |
| Ulcerative Colitis Market Size (2022) |
$4.4 billion |
IQVIA, 2022 |
| Crohn’s Disease Market Size (2022) |
$3.2 billion |
IQVIA, 2022 |
| Global IBD Market Growth (2022-2027) |
6.8% CAGR |
MarketsandMarkets, 2022 |
The combined market for ulcerative colitis and Crohn’s disease treatments exceeds $7.6 billion, with a sustained growth rate facilitated by increased diagnosis, unmet needs, and adoption of oral therapies.
Competitive Landscape
Major competitors:
- JAK inhibitors (Xeljanz, Olumiant)
- Vascular adhesion molecule inhibitors (Entyvio, Stelara)
- Biologics and biosimilars (Humira, Skyrizi)
Etrasimod's competitive advantage lies in oral administration and its selectivity, which may lead to favorable patient adherence and lower side-effect profiles.
Pricing and Revenue Projections
| Scenario |
Year 1 |
Year 3 |
Year 5 |
Comments |
| Optimistic Price |
$55,000 |
$55,000 |
$55,000 |
Based on current biologic benchmarks, adjusted for oral delivery and dosage frequency |
| Conservative Price |
$45,000 |
$50,000 |
$50,000 |
Reflects price competition and payer negotiation tactics |
| Market Penetration (Year 1) |
10% of eligible IBD patients |
|
|
Estimated from early adoption and ongoing trial results |
| Market Penetration (Year 3) |
40% |
|
|
Growth driven by positive trial data and regulatory approval |
Estimated U.S. Market Access
Assuming a target population of approximately 1 million IBD patients in the U.S.:
- Year 1 sales can reach up to $100 million with 10% penetration at a $45,000 price.
- Year 3 sales can surpass $400 million with 40% penetration and sustained pricing.
Pricing Trends Compared to Competitors
- Biologics like Stelara priced around $65,000 annually.
- Oral agents like Xeljanz range from $50,000 to $60,000.
- Etrasimod, if positioned competitively, could price between $45,000 and $55,000, offering a price advantage due to oral delivery and safety profile.
Regulatory and Market Entry Risks
- Pending Phase 3 results significate.
- Timelines for NDA submission and approval depend on trial outcomes.
- Payer acceptance hinges on demonstrated efficacy, safety, and cost-effectiveness.
Conclusion
Etrasimod is poised to capture a significant share of the IBD treatment market upon regulatory approval. Price points between $45,000 and $55,000 are sustainable, considering competitive products and oral delivery advantages. Market penetration relies on positive trial outcomes and payer acceptance, with total sales potential reaching several hundred million dollars in the near term.
Key Takeaways
- Etrasimod targets a growing IBD market projected to reach over $7.6 billion globally by 2027.
- The drug’s potential market entry timing hinges on Phase 3 trial results and FDA approval.
- Pricing is likely to range from $45,000 to $55,000 annually, competitive with other oral therapies.
- Early adoption could generate approximately $100 million in Year 1 U.S. sales; this could increase to over $400 million by Year 3 with market expansion.
- Market success depends on safety, efficacy data, and payer policies.
FAQs
1. What factors influence Etrasimod’s pricing strategy?
Competitive pricing considers existing biologics and oral therapies, manufacturing costs, safety profile, and payer reimbursement negotiations.
2. When is Etrasimod expected to launch commercially?
Expected NDA submission could occur within 12-18 months following successful Phase 3 outcomes, with approval roughly 6-12 months thereafter.
3. How does Etrasimod differentiate from existing IBD therapies?
It offers oral administration, potential safety advantages, and targeted selectivity, potentially improving patient adherence over biologics.
4. What is the risk of market entry delays?
Delays depend on trial results, regulatory review processes, and competitive market dynamics. Negative trial outcomes could significantly impact projected revenues.
5. Which markets have the highest revenue potential for Etrasimod?
The United States remains the largest market due to high IBD prevalence and managed care infrastructure, followed by Europe and Asia where IBD diagnoses increase.
Sources:
[1] IQVIA, 2022.
[2] MarketsandMarkets, 2022.
