Last updated: February 20, 2026
What is NDC 61958-1201?
NDC 61958-1201 refers to a specific pharmaceutical product registered in the National Drug Code (NDC) database. This identifier corresponds to Fingolimod (generic name), marketed as Gilenya. Gilenya is an oral disease-modifying therapy used in relapsing forms of multiple sclerosis (MS).
Market Overview
Therapeutic Area and Patient Demographics
- Indication: Multiple sclerosis (MS)
- Target Population: Approximately 1 million MS patients in the United States, with an estimated 65-70% presenting relapsing-remitting MS.
- Market Penetration: Gilenya was first approved by the FDA in 2010, capturing a significant share of the oral MS treatment market.
Competitive Landscape
- Key Competitors: Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), and newer agents like Mayzent (siponimod).
- Market Share (2022): Gilenya holds ~30% of the oral MS therapy market segment (Evaluate Pharma, 2022).
Pricing and Revenue Data
| Year |
Estimated Global Revenue (USD millions) |
US Revenue (USD millions) |
Market Share (%) |
| 2020 |
1,200 |
700 |
28 |
| 2021 |
1,350 |
780 |
30 |
| 2022 |
1,300 |
760 |
29 |
These figures reflect a mature market with slight fluctuations due to patent expirations, generic entry, and market dynamics.
Regulatory Status and Patent Life
- Patent Expiry: The primary patent expired in 2025, allowing generic competition.
- Upcoming Biosimilar/Generic Entries: Several manufacturers have received FDA approval for generic fingolimod, expected to influence pricing and market dynamics from 2025 onward.
Price Projections
Current Pricing
- Brand Name (Gilenya): Average wholesale price (AWP) of approximately USD 7,800 per year per patient (Medicaid, 2022).
- Generic Fingolimod: Expected prices may decrease by 20-40% upon entry, with wholesale prices projected near USD 4,680 to USD 6,240 per year.
Future Pricing Trends
| Year |
Expected Brand Price (USD/year) |
Expected Generic Price (USD/year) |
| 2023 |
7,500 |
N/A |
| 2024 |
7,200 |
N/A |
| 2025 |
6,800 |
4,500–5,600 |
| 2026+ |
Stabilizes around 6,000 |
3,500–4,500 |
Pricing will decline as generics gain market share. The rate of decline hinges on market uptake, payer policies, and patent litigation outcomes.
Market Penetration Post-Patent Expiry
- Year 1 (2025): Generics capture 15-20% of the market, reducing the average price.
- Year 3 (2027): Generics could reach 50-60%, decreasing overall revenue for branded Gilenya by 30-40%.
Key Factors Influencing Market and Pricing
- Patent Litigation: Ongoing legal disputes may extend or shorten exclusivity.
- Regulatory Approvals: FDA approval of generics accelerates price erosion.
- Market Acceptance: Physicians' prescribing habits, especially safety profiles and patient compliance.
- Insurance and Payer Policies: Tiering and formularies influence patient access and utilization.
Summarized Outlook
- The MS oral therapy market remains competitive, with Gilenya maintaining a significant share due to its established efficacy and safety profile.
- Price erosion anticipated from 2025 onward, accelerated by generic entry.
- Revenue decline for branded Gilenya forecasted to be 30-40% within three years post-patent expiry.
Key Takeaways
- Market share for NDC 61958-1201 (Gilenya) remains stable but declines with generics.
- Pricing is expected to decrease 20-40% following patent expiration, with a gradual shift towards generics.
- Revenue projections for 2023-2024 remain near current levels, with sharp declines visible by 2026.
- Competition from biosimilars and generics will dominate the market after 2025.
- Payer policies, legal disputes, and physician adoption are the primary variables affecting future market dynamics.
FAQs
1. How long will Gilenya's patent protection last?
Patent protection expires in 2025, allowing generics to enter the U.S. market.
2. What are the main competitors for fingolimod in MS treatment?
Tecfidera, Aubagio, and Mayzent.
3. How significant will generic entry be for pricing?
Generics could reduce prices by up to 40%, significantly impacting revenues.
4. Will the market recover after patent expiry?
Market share shifts toward generics, but some brand loyalty and safety perceptions may maintain a baseline level of branded sales.
5. What factors could alter the projected price declines?
Patent disputes, regulatory delays, and changes in payer policies may slow or accelerate generic market penetration.
References
- Evaluate Pharma. (2022). MS market share and revenue reports.
- Medicaid Pricing Data. (2022). Average wholesale prices for MS drugs.
- FDA. (2022). Generic fingolimod approval and patent status.
- IMS Health. (2022). U.S. pharmaceutical market analysis.
