Last updated: February 23, 2026
What is the drug with NDC 83301-0011?
The National Drug Code (NDC) 83301-0011 refers to Yeliva (etrasimod), a selective S1P receptor modulator developed by Arena Pharmaceuticals for inflammatory and autoimmune diseases, including ulcerative colitis and Crohn's disease. It is still undergoing clinical trials with no recent FDA approval.
Market landscape overview
Size and growth potential
The global inflammatory bowel disease (IBD) treatment market was valued at USD 9.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of approximately 6.5% through 2030 [1]. This growth indicates increasing demand for novel therapies like etrasimod, especially as current treatment options face limitations such as side effects and resistance.
Key competitors
- Ozanimod (Zeposia) by Bristol-Myers Squibb
- Vedolizumab (Entyvio) by Takeda
- Ustekinumab (Stelara) by Janssen
Etrasimod aims to carve a niche within this landscape due to its oral administration and targeted mechanism.
Clinical and regulatory status
Etrasimod has shown promising results in phase 2 and phase 3 trials for ulcerative colitis and Crohn's disease, with phase 3 trials ongoing as of 2023 [2]. The drug’s approval timeline remains uncertain, with potential FDA approval forecasted between late 2024 and 2025, depending on trial outcomes.
Pricing benchmarks and projections
Current pricing for leading therapies
| Drug |
Indication |
List Price (Annual) |
Key Notes |
| Zeposia (ozanimod) |
Multiple sclerosis, UC |
USD 88,000 |
Oral, first approved in 2020 |
| Entyvio (vedolizumab) |
UC, Crohn’s |
USD 97,000 |
IV administration, since 2014 |
| Stelara (ustekinumab) |
Crohn’s, UC |
USD 65,000–70,000 |
Subcutaneous, since 2009 |
Estimated price range for etrasimod
- Initial price projection: USD 75,000 – USD 85,000 annually
- Rationale: Competitors’ prices serve as a baseline; etrasimod’s oral delivery and strong clinical efficacy may command a premium initially.
- Long-Term trend: Prices could decrease by 10–20% over five years due to market competition and biosimilar entry or generic formulations if patent exclusivity is challenged.
Pricing strategies and reimbursement
Launch considerations
- Premium positioning for superior tolerability over biologics and IV therapies.
- Reimbursement challenges may limit initial adoption; securing inclusion in major formularies will be essential.
- Pricing flexibility could be implemented through tiered payment models, especially for chronic disease management.
Market entry risks and opportunities
- Risks: Regulatory delays, clinical trial failures, or unfavorable pricing assessments.
- Opportunities: Growing patient population, unmet needs for oral therapies, potential for combination therapies.
Key market drivers
- Increasing prevalence of IBD globally.
- Patient preference for oral medications.
- Limitations of existing biologic therapies, including administration routes and side effects.
Conclusion
Etrasimod’s market entry hinges on success in ongoing trials and regulatory approval. Its price position aligns with existing oral small molecules in the IBD space, with initial projections set between USD 75,000 and USD 85,000 per year. Competitive dynamics and payer negotiations will influence its ultimate market share and pricing trajectory.
Key Takeaways
- The IBD treatment market is projected to grow at 6.5% CAGR through 2030.
- Etrasimod's potential launch price is estimated at USD 75,000–USD 85,000 annually.
- Market competition includes Zeposia, Entyvio, and Stelara, with prices ranging from USD 65,000 to USD 97,000 annually.
- Success depends on trial outcomes, regulatory approval, and formulary access.
- Long-term price trends may decline due to market saturation and biosimilar entry.
FAQs
1. When is etrasimod expected to gain FDA approval?
Pending successful phase 3 trial results, approval is anticipated between late 2024 and mid-2025.
2. How does etrasimod differentiate from existing drugs?
Its oral administration and targeted S1P receptor modulation aim for better safety and patient compliance compared to biologic options.
3. What factors could influence initial pricing?
Clinical efficacy, safety profile, competitor pricing, payer negotiations, and market demand.
4. What is the potential impact of biosimilars on etrasimod pricing?
Biosimilars may drive prices down over time; however, as a small molecule, etrasimod faces less biosimilar competition initially.
5. How significant is the market for IBD therapies?
It exceeds USD 9.8 billion globally, with consistent growth driven by increased prevalence and patient preference for oral treatments.
References
[1] Grand View Research. (2023). Inflammatory Bowel Disease Market Size, Share & Trends.
[2] Arena Pharmaceuticals. (2023). Clinical Trial Updates on Etrasimod.
