Last updated: March 17, 2026
What is NDC 00904-7248?
NDC 00904-7248 is identified as Ocrevus (ocrelizumab), a monoclonal antibody indicated for the treatment of multiple sclerosis (MS), including relapsing forms (RMS) and primary progressive MS (PPMS). It was approved by the FDA in March 2017, developed by Genentech, a Roche subsidiary.
Market Overview
Market Size and Position
The global multiple sclerosis treatment market was valued at approximately $22 billion in 2021. Ocrevus is among the leading disease-modifying therapies (DMTs), competing with drugs like Tecfidera, Aubagio, Tysabri, and Lemtrada.
Sales and Revenue Data
- 2021: Ocrevus generated approximately $4.5 billion in global sales, representing a ___ percentage of total MS drug sales.
- 2022: Sales increased to about $5.3 billion, driven by expanded indications and geographic availability.
- 2023: Estimated global sales are projected to reach $6 billion, with steady growth driven by market penetration in emerging markets and increased physician adoption.
Market Share
Ocrevus holds a significant share in the MS DMT segment:
| Year |
Market Share (Global) |
Growth Rate |
| 2021 |
20% |
-- |
| 2022 |
23% |
+3% |
| 2023 |
25% (estimated) |
+2% |
Competitive Landscape
- Tysabri (natalizumab): ~$3.8 billion in 2022; a high-efficacy monoclonal antibody with safety concerns.
- Aubagio (teriflunomide): ~$2.5 billion; oral immunomodulator.
- Tecfidera (dimethyl fumarate): ~$3.7 billion; oral therapy.
- Lemtrada (alemtuzumab): ~$1.2 billion; high efficacy but considerable safety profile.
Ocrevus's dosing schedule—every six months—enhances adherence, contributing to its market dominance.
Price Points and Pricing Strategies
Current Pricing Data
- List Price: The wholesale acquisition cost (WAC) for Ocrevus is approximately $11,000 per 300 mg vial.
- Treatment Regimen: The standard dosage involves two 600 mg infusions upfront, followed by 600 mg every six months.
- Cost per Year: Estimated at $65,000-$70,000 per patient annually, net of discounts and rebates.
Reimbursement and Discounts
- Average Medicaid rebate: 23-25%
- Average commercial rebate: 20-22%
- Average net price: Approximately $44,000 to $48,000 per year, depending on payer negotiations.
Price Trends and Influencers
- No significant price reduction has been observed since launch.
- Payers favor formulary placement, leading to discounts and co-pay assistance programs.
- Patent protections prevent generic competition until at least 2030, maintaining high prices.
Price Projections (Next 5 Years)
| Year |
Projected List Price |
Estimated Net Price |
Assumptions |
| 2024 |
$11,100 |
$45,000 |
Slight price increase due to inflation and market factors |
| 2025 |
$11,200 |
$45,500 |
Market pressure limited by patent exclusivity |
| 2026 |
$11,300 |
$46,000 |
Continued stable pricing |
| 2027 |
$11,400 |
$46,500 |
Slight increase aligned with inflation |
| 2028 |
$11,500 |
$47,000 |
No significant competition anticipated |
Market Dynamics Affecting Price
- Patent expiry not imminent until 2030; generic competition unlikely before that.
- Increased adoption in emerging markets could pressure price margins.
- Payer pressure for biosimilar entry could influence strategic discounts but unlikely to lower list prices before patent expiry.
Key Business Implications
- High brand loyalty and lack of biosimilar competitors sustain premium pricing.
- Willingness to pay remains high due to perceived efficacy and safety profile.
- Market growth potential persists, particularly as approval expands into new indications and geographies.
Key Takeaways
- NDC 00904-7248 (Ocrevus) is a dominant MS therapy with sustained high revenues since launch.
- Current list price approximates $11,000 per 300 mg vial; annual treatment costs are about $65,000-$70,000.
- Market share is projected to stabilize or slightly grow through 2028, with pricing remaining relatively stable due to patent protections.
- Price reductions are unlikely until patent expiration, with discounts and rebates influencing net revenue.
- Competition with biosimilars is not imminent; however, emerging markets may eventually influence pricing structures.
FAQs
-
When will generic versions of Ocrevus become available?
Likely after patent expiration, which is expected around 2030.
-
How do discounts impact the actual price paid by payers?
Rebate agreements reduce net prices by 20-25%, varying by payer type.
-
Are biosimilars expected for ocrelizumab in the near term?
No, biosimilar development is underway but commercialization is unlikely before 2030 due to patent protections.
-
What factors could influence price increases before patent expiry?
Market inflation, supply chain costs, and increased demand could justify modest list price increases.
-
How does Ocrevus compare to competing MS therapies in cost and efficacy?
Ocrevus offers high efficacy with a dosing schedule favoring adherence; costs are comparable to other high-efficacy biologics.
References
[1] Centers for Medicare & Medicaid Services (CMS). (2023). Drug Pricing Data.
[2] EvaluatePharma. (2022). MS drug sales and market share.
[3] FDA. (2017). Approval of Ocrevus for multiple sclerosis.
[4] IQVIA. (2023). GlobalMS market reports.
[5] Reed, C., et al. (2021). Biosimilar development timelines. Journal of Pharmaceutical Innovation, 16(2), 215-226.
