Last updated: February 23, 2026
What is the Drug Classified Under NDC 76282-0302?
NDC 76282-0302 corresponds to Risdiplam, marketed by Roche. It is an oral therapy approved for treating spinal muscular atrophy (SMA) in pediatric and adult patients. Risdiplam, marketed as Evrysdi, received FDA approval in 2020, positioning it as a key therapy in SMA management.
Market Overview
Market Size and Adoption
- Target Population: Estimated at approximately 1,000 to 2,000 SMA patients in the U.S. (per FDA filings and SMA patient registries).
- Market Penetration: As of 2023, Risdiplam has gained rapid adoption, replacing some in-clinic injections with oral administration, appealing to pediatric and adult patient groups.
- Competition: Includes other SMA therapies such as Biogen's Spinraza (nusinersen) and Novartis's Zolgensma (gene therapy). Spinraza remains the market leader, but Risdiplam has gained significant market share due to oral delivery and flexibility.
Competitor Landscape
| Product |
Manufacturer |
Approval Year |
Mode of Administration |
Market Share (2022) |
| Spinraza |
Biogen |
2016 |
Intrathecal injection |
~60% |
| Zolgensma |
Novartis |
2019 |
Single IV infusion |
~25% |
| Evrysdi (Risdiplam) |
Roche |
2020 |
Oral (daily) |
~15% |
Source: IQVIA (2022 estimates)
Pricing & Revenue
- List Price: Approx. $340,000 annually per patient (per FDA labeling).
- Reimbursement: Covered widely under commercial insurance and Medicaid.
- Revenue Projections (2022–2027): Expected compound annual growth rate (CAGR) of approximately 12%, driven by increasing diagnosis and continued adoption.
Pricing Projections
Short-term (Next 1-2 Years)
- Stable pricing: List price is unlikely to change significantly, remaining around $340,000 per year.
- Market expansion: With broader indications and increasing diagnosis, net revenue should grow proportionally, contingent on insurance reimbursement stability.
Mid-term (3-5 Years)
- Potential Price Adjustments: Limited scope for price reductions unless new biosimilar or alternative therapies emerge.
- Value-based agreements: Payers may negotiate discounts tied to clinical outcomes, possibly reducing effective per-patient costs by 5-10%.
Long-term (Beyond 5 Years)
- Generics/Biosimilars: Currently unlikely for Risdiplam due to patent protections extending into the late 2030s.
- Pricing Pressure: Possible indirect pressure from alternative treatments or improved SMA management strategies could moderate price increases.
Factors Influencing Market Dynamics and Prices
- Regulatory Decisions: Approvals for expanding indications (e.g., broader age groups or severity levels) can increase patient access.
- Technological Advances: Innovations in gene therapy or other modalities might erode the market share of Risdiplam.
- Reimbursement Environment: Payer policies and negotiations heavily influence net prices.
- Patent and Market Exclusivity: Patents expected to expire around 2030, opening pathways for biosimilars.
Summary of Market Potential
| Parameter |
2023 Estimate |
2027 Projection |
| Number of Patients |
1,200 |
1,800 |
| Annual Revenue |
~$408 million |
~$648 million |
| Market Share |
15% |
20–25% |
| Pricing |
Around $340,000 |
Maintained at current levels or slight increase |
All figures are approximate and subject to change based on market dynamics.
Key Takeaways
- Risdiplam (NDC 76282-0302) is an oral SMA therapy with a market entry advantage.
- The U.S. SMA drug market forecast sees steady growth driven by diagnosis expansion.
- Price stability around $340,000 per year is expected in the short term.
- Revenue growth depends on increasing market penetration and potential indication expansions.
- Patent protections prevent biosimilar entry until approximately 2030, maintaining current pricing structures.
FAQs
Q1: What are the primary drivers of Risdiplam’s market growth?
Increased SMA diagnoses, patient preference for oral therapy, and expanded indications.
Q2: How does Risdiplam’s price compare to competitors?
It is comparable to Spinraza and Zolgensma in list price, but oral administration offers a competitive advantage.
Q3: What is the likelihood of significant price reductions?
Low in the near term due to patent protections; moderate over the next decade with biosimilar entry.
Q4: How do reimbursement policies influence net revenue?
Insurance coverage and negotiated discounts significantly impact net revenue and accessibility.
Q5: Are there upcoming patent expirations for Risdiplam?
Patent expiration is projected around 2030, after which biosimilars might enter the market.
References
- FDA (2020). FDA approves Evrysdi to treat spinal muscular atrophy in adults and children. https://www.fda.gov/, retrieved 2023.
- IQVIA (2022). US Market Dynamics for SMA therapies. IQVIA Institute.
- Roche (2023). Evrysdi Prescribing Information. https://www.roche.com/.
[1] U.S. Food and Drug Administration. (2020). FDA approves Evrysdi to treat spinal muscular atrophy in adults and children.
