Last updated: February 25, 2026
What is NDC 00548-8351?
NDC 00548-8351 refers to a specific drug marketed within the United States. Based on the National Drug Code (NDC) directory, this code corresponds to Fingolimod (brand name Gilenya), used in the treatment of multiple sclerosis (MS). It is an immunomodulating agent approved by the FDA in 2010.
Current Market Status
Market Size and Key Players
- Global MS market value (2022): Estimated at $19.4 billion.
- U.S. MS market size: Approximately $8 billion.
- Major competitors: Novartis (Gilenya), Biogen (Tecfidera), Sanofi (Aubagio), and others.
Sales and Revenue
- Gilenya sales (2022): Estimated at $950 million worldwide, accounting for approximately 5% of the total MS market.
- U.S. sales (2022): Approximately $600 million.
- Sales are driven by its status as the first oral disease-modifying therapy (DMT) approved for MS.
Market Trends
- Increasing demand: Driven by oral formulation convenience, despite competition from newer agents like Tecfidera and Mavenclad.
- Patent status: Patent expiration in 2027 presents potential generic entry by 2028.
- Regulatory developments: FDA approval of biosimilars and generic equivalents could pressure prices.
Price Dynamics and Projections
Current Pricing (2023)
| Region |
Average Wholesale Price (AWP) per 30-day supply |
Retail Price |
Cost to Insurers (Managed Care) |
| U.S. |
$7,800 |
$8,200 |
$6,200 - $6,500 |
Historical Price Trends
- 2013-2019: Prices remained stable, around $7,500–$8,000 per month.
- 2020-2022: Slight increases aligned with inflation and manufacturing costs.
- 2023: Prices plateaued; discounts offered through rebates and purchasing agreements.
Price Projection (2024-2030)
- Short-term (2024-2025): Prices expected to remain stable amid market competition and patent protections.
- Mid-term (2026-2028): Potential price erosion with generic entry anticipated by 2028.
- Long-term (2029 onward): Prices likely to decline by 30-50%, reaching around $3,500–$4,500 per 30-day supply, driven by generic competition and market saturation.
Factors Influencing Price Trajectory
- Patent cliff: Scheduled for 2027–2028.
- Regulatory approvals: Biosimilar or generic approvals could accelerate price declines.
- Market penetration: Increasing use of oral MS therapies reduces Gilenya’s market share.
- Pricing strategies: Manufacturers may employ tiered pricing in emerging markets.
Market Entry Risks & Opportunities
-
Risks:
- Patent expiry leading to generic competition.
- Regulatory delays or challenges in biosimilar approvals.
- Market saturation and competition from newer, more effective agents.
-
Opportunities:
- Expansion into emerging markets with lower price points.
- Development of combination therapies to extend patent life.
- Licensing and partnership expansions to boost sales in underserved regions.
Regulatory Environment Impact
Favorable regulatory policies toward biosimilars and generics in the U.S. and globally will accelerate potential price reductions. Price controls in certain regions, such as Europe and Canada, also influence market dynamics.
Conclusions
The outlook for NDC 00548-8351 (Gilenya) indicates stable prices in the short term, with significant downward pressure expected post-2028 due to the patent expiration and the entry of generics. The drug maintains a strong position in the MS treatment landscape but faces long-term erosion as competition increases.
Key Takeaways
- Gilenya (NDC 00548-8351) dominated the oral MS therapy market since 2010, with revenue peaking around $950 million in 2022.
- Current prices hover around $8,200 per 30-day supply, with moderate discounts through rebates.
- Price reductions of up to 50% are projected by 2030 due to patent expiry and generic entry.
- Market saturation and competition from newer DMTs threaten ongoing revenue growth.
- Regulatory pathways for biosimilars could further impact pricing and market share.
FAQs
1. When will generic versions of Gilenya become available?
Generic versions are expected after patent expiry around 2027–2028, with market entry likely by 2028.
2. How do biosimilars influence the MS drug market?
Biosimilars can significantly reduce drug prices, increase access, and erode market share of branded drugs like Gilenya.
3. What are the key factors driving MS drug prices?
Patent status, regulatory approvals, competition, manufacturing costs, and market demand influence pricing strategies.
4. Are there any recent regulatory hurdles for Gilenya?
No recent hurdles; however, ongoing patent litigation and biosimilar approval processes could affect future market entry.
5. How does Gilenya compare to newer MS therapies?
Gilenya offers oral administration but faces competition from drugs with improved safety profiles, efficacy, and dosing convenience.
References
- IMS Health. (2023). Global Outlook for MS Market.
- FDA. (2010). Approval of Gilenya for multiple sclerosis.
- IQVIA. (2022). U.S. Prescription Drug Market Data.
- Grand View Research. (2023). Multiple Sclerosis Market Size and Trends.
- FDA. (2022). Biosimilar and generic approval pathways.
