Last updated: February 14, 2026
What is the drug associated with NDC 45802-0129?
NDC 45802-0129 identifies Ocrevus (ocrelizumab), a monoclonal antibody developed by Roche. It is approved for the treatment of multiple sclerosis (MS), including relapsing forms and primary progressive MS.
Market Size and Adoption
Global and U.S. MS Treatment Market
- The MS market was valued at approximately $26 billion in 2021 and projected to reach $36 billion by 2030, growing at a compound annual growth rate (CAGR) of around 4.5% (source: GlobalData).
Ocrevus’s Position
- Launched in 2017, Ocrevus has become a leading therapy with a significant share, roughly 35-40%, in the U.S. DMT (disease-modifying therapy) market for MS, based on prescriptions and revenue data.
Patient Population
- U.S. MS prevalence estimates: 1 million individuals. Approximately 85% have relapsing-remitting MS (RRMS), with secondary progressive MS accounting for the rest. Taken together, about 600,000 to 800,000 patients could be eligible for Ocrevus.
Market Penetration
- As a first-line treatment with high efficacy, Ocrevus is administered biannually, making it a preferred option for neurologists. Its market penetration exceeds that of some competitors like Tecfidera or Avonex, which are less efficacious or require more frequent dosing.
Current Pricing Model
List Price
- The wholesale acquisition cost (WAC) for Ocrevus is approximately $65,000 per year per patient, based on recent data from Express Scripts and manufacturer disclosures.
Reimbursement and Payer Coverage
- Majority of commercial payers reimburse at or near list price, with some discounts. Medicare Part B covers a significant portion, commonly with co-payments around 20% of the drug's list price.
Cost-Effectiveness
- Studies show Ocrevus’s cost-effectiveness aligns with premiums over older therapies, especially considering its efficacy in reducing relapses and delaying disability progression.
Price Projections
Short-Term (Next 2 Years)
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No major price reductions expected. Ocrevus remains a premium-priced drug, justified by its efficacy and dosing schedule.
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Price adjustments may be limited, focused on discounts or managed care negotiations. List prices are likely to remain within the $65,000-$70,000 range.
Factors influencing future pricing
- Competition from biosimilars or generics: No biosimilar for Ocrevus announced as of 2023, influencing stable pricing.
- Patent protections: The original patent expires around 2027 in the U.S., with extensions possibly granted.
- Market dynamics: Increased biosimilar entry or multiple sclerosis paradigm shifts could pressure prices starting from mid-2020s.
Medium to Long-Term (3-5 Years)
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Potential for moderate price erosion due to biosimilar market entry, discounted contract arrangements, or expanded use of generics.
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Price declines anticipated to be in the 10-20% range, bringing the annual cost down to approximately $52,000 - $58,000, depending on competitive landscape and formulary positioning.
Competitive Landscape Impact
| Competitor |
Market Share (2022) |
Price Range (per year) |
Key Features |
| Mavenclad (Cladribine) |
10-12% |
$44,000 |
Oral administration, shorter treatment cycle |
| Tecfidera (Dimethyl fumarate) |
10-15% |
$67,000 |
Oral, earlier MS therapy |
| Kesimpta (Ofatumumab) |
8-10% |
$64,000 |
Self-injected, high efficacy |
The upcoming biosimilar market expected post-2027 may significantly reduce Ocrevus’s price or switch reimbursed therapies, depending on regulatory approval timelines and scientific interchangeability.
Key Takeaways
- NDC 45802-0129 corresponds to Ocrevus, a leading DMT with an established market presence in MS.
- The U.S. market size for MS therapies exceeds $26 billion, with Ocrevus maintaining a dominant share.
- Current list price is about $65,000 annually, with reimbursement patterns favoring stable pricing.
- Short-term projections hold prices steady; mid-term projections indicate a potential 10-20% decline post-patent expiry.
- Competitive pressures and biosimilar developments will influence pricing dynamics beyond 2027.
FAQs
1. When will biosimilars for Ocrevus likely enter the U.S. market?
Potential approval around 2027, five years after patent expiration, contingent on regulatory filings and manufacturer strategies.
2. How does Ocrevus compare to other MS therapies in cost?
Ocrevus’s annual cost is comparable to other high-efficacy therapies, roughly $65,000, but oral options like Mavenclad are slightly cheaper.
3. What factors could accelerate price reductions for Ocrevus?
Introduction of biosimilars, patent challenges, or shifts toward oral therapies could exert downward pressure.
4. How is payer coverage likely to evolve?
Payers favor therapies with proven efficacy; Ocrevus’s dosing frequency and efficacy support continued favorable reimbursement, though discounts may increase with biosimilar competition.
5. What opportunities exist for new entrants or adjuncts?
Development of biosimilars, combination treatments, or novel therapeutics targeting unmet MS needs could reshape the landscape.
Sources
- GlobalData, "Multiple Sclerosis Market Analysis," 2022.
- Express Scripts drug pricing database, 2023.
- FDA approval documents for Ocrevus, 2017.
- Roche press releases, 2022.
- Medicare Part B drug coverage policies, 2023.
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