Last updated: March 11, 2026
What is NDC 51407-0016?
NDC 51407-0016 refers to a specific drug product listed in the National Drug Code database. It is identified as Ozanimod (Zeposia), approved by the U.S. Food and Drug Administration (FDA) for treatment of relapsing forms of multiple sclerosis (MS) and ulcerative colitis. The drug is manufactured by Bristol-Myers Squibb.
Market Overview
Indication and Approved Uses
- Multiple Sclerosis (MS): Approved in March 2020.
- Ulcerative Colitis: Approved in May 2021.
Market Size and Trends
- The US MS treatment market was valued at approximately $8.5 billion in 2022. It has experienced steady growth at a compound annual growth rate (CAGR) of around 4.2% (EvaluatePharma, 2022).
- The ulcerative colitis segment is smaller but growing, estimating a market value near $1.2 billion with an expected CAGR of approximately 5.7% through 2028 (GlobalData, 2022).
Competitors and Market Share
- For MS, competing drugs include interferons, fingolimod, and siponimod.
- For ulcerative colitis, primary competitors are infliximab, vedolizumab, and tofacitinib.
Market Penetration
- As a new oral therapy, Ozanimod is rapidly gaining market share due to its favorable safety profile and convenience.
- Estimated to hold approximately 12% of the MS segment and 8% of the ulcerative colitis segment as of late 2022 (IQVIA, 2022).
Pricing and Reimbursement Landscape
Current Pricing
- Wholesale Acquisition Cost (WAC): Near $7,845 per year for the MS indication.
- Retail/Patient Cost: Varies based on insurance, but typically around $10,500 annually without copay assistance.
Reimbursement Policies
- Covered by Medicare, Medicaid, and most commercial insurers.
- Prior authorization required; formulary placement influences patient access.
Cost Comparison
| Drug |
Indication |
Annual Cost (USD) |
Market Share (2022) |
Comments |
| Ozanimod (NDC 51407-0016) |
MS & Ulcerative Colitis |
$7,845 |
12% (MS), 8% (UC) |
Competitive oral option; newer to market |
| Fingolimod |
MS |
$88,000 |
35% |
More expensive, less tolerable side effects |
| Infliximab |
UC |
$27,000 |
20% |
Biologic, infusion-based, higher costs |
Price Projections
- 2023–2027 Outlook: Prices are expected to stabilize around current levels due to market competition, with minor fluctuations tied to inflation, manufacturing costs, and reimbursement adjustments.
- Pricing Trends: With increased competition from biosimilars and oral small molecules, price reductions of 10–15% are probable over five years.
Pricing Factors
- Patent exclusivity extends until at least 2032.
- Ongoing negotiations with pharmacy benefit managers (PBMs) may influence net prices.
- Adoption rates could pressure manufacturers to offer discounts or patient assistance programs.
Revenue Projections
- Based on current market penetration, estimated sales in the US could reach $1.2 billion annually by 2025, assuming market share growth of 3–4% annually.
- International markets provided in separate estimations; expected to contribute an additional 15–25% of total revenue.
Risks and Opportunities
Risks
- Patent cliffs or generic/biosimilar entrants.
- Regulatory changes impacting reimbursement.
- Competition from emerging therapies with better efficacy or safety profiles.
Opportunities
- Broadening indications.
- Expansion into other geographies.
- Development of combination therapies.
Key Takeaways
- NDC 51407-0016 corresponds to Ozanimod, a recent entrant in the MS and ulcerative colitis markets.
- Market size is projected to grow at mid-single-digit rates, with current US revenues near $1.2 billion.
- Pricing remains stable but could decline due to increased competition and payer negotiations.
- Strategic initiatives should consider expanding indications, geographic reach, or optimizing patient access programs.
FAQs
1. What are the main competitive advantages of Ozanimod?
Ozanimod offers an oral administration route, a favorable safety profile, and daily dosing, which enhances patient adherence compared to injectable biologics.
2. How likely are prices to decrease over the next five years?
Prices could decline by 10–15%, primarily driven by increased market competition, biosimilars, and payer discounting strategies.
3. What regulatory challenges could impact the market?
Potential delays in approval for new indications or unfavorable rulings on patent extensions could affect market exclusivity and pricing.
4. How does Ozanimod’s market share compare to its competitors?
It holds approximately 12% of the MS market and 8% of the ulcerative colitis market, positioning it as a significant but not dominant player.
5. Are there upcoming patent expirations or biosimilar entries anticipated?
Patent protections extend until at least 2032; no biosimilar competitors currently threaten Ozanimod, but biosimilar development for biologics remains active.
References
[1] EvaluatePharma. (2022). Market forecasts for MS therapies.
[2] GlobalData. (2022). Ulcerative colitis market analysis.
[3] IQVIA. (2022). Prescription Trends and Market Share Reports.
[4] FDA. (2020–2022). Drug approvals and labeling updates.
