Last updated: February 15, 2026
Overview of NDC 62135-0493
NDC 62135-0493 is a prescription drug listed in the National Drug Code directory. Specific details about its formulation, therapeutic class, and indications are necessary for detailed analysis. Based on available data sources, this NDC corresponds to Ocrelizumab (Ocrevus), a monoclonal antibody used primarily for multiple sclerosis (MS).
Market Landscape
Therapeutic indication:
Ocrelizumab is approved for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Its approval by the FDA in 2017 strengthened its market share in MS treatments.
Market Size & Growth:
The MS drug market globally is valued at approximately USD 24 billion in 2022, with a compound annual growth rate (CAGR) of about 4%. Ocrelizumab holds a significant segment due to its efficacy in both RMS and PPMS.
Competitive Landscape:
Key competitors include:
- Natalizumab (Tysabri): Sales of about USD 2.2 billion in 2022.
- Alemtuzumab (Lemtrada): Approximate revenue USD 800 million.
- Cladribine (Mavenclad): USD 250 million in 2022.
- Injectable interferons and glatiramer acetate: Combined sales exceeding USD 6 billion.
Ocrelizumab's position is bolstered by its novel mechanism (anti-CD20 monoclonal antibody) and approval for PPMS, a subset with limited treatment options. Sales estimates for Ocrelizumab reached approximately USD 2.8 billion globally in 2022.
Pricing Dynamics
Pricing in the U.S.:
- The Wholesale Acquisition Cost (WAC): approximately USD 7,700 per 300 mg vial.
- A typical dosing regimen involves two 300 mg infusions initially, followed by 600 mg every six months.
- Estimated annual treatment cost per patient: USD 75,000–USD 85,000, depending on dose adjustments and pharmacy discounts.
Pricing in Other Markets:
- Europe: Prices are generally 20–30% lower, varying significantly per country due to healthcare system policies.
- Canada and Australia: Similar prices to the U.S., adjusted for local regulations.
Price Projections and Market Trends
Short-term (Next 1–2 Years):
- No significant price reductions expected; rebates and discounts may increase as competition intensifies.
- Introduction of biosimilars is unlikely due to the complex manufacturing process and patent protections.
Medium to Long-term (3–5 Years):
- Patent expiry for Ocrelizumab is projected around 2027–2028.
- Upon patent expiration, biosimilar versions could enter the market, potentially reducing prices by 20–40%.
- Biosimilar competition could drive the annual treatment cost down to USD 50,000–USD 60,000 in the U.S.
Market Drivers & Barriers:
- Increasing prevalence of MS worldwide, particularly in North America and Europe, sustains demand.
- Price sensitivity in healthcare systems and insurance coverage influences actual reimbursement values.
- High development cost and regulatory barriers limit rapid biosimilar entry.
Key Factors Affecting Future Pricing
| Factor |
Impact |
| Patent expiry |
May lead to price erosion due to biosimilar competition. |
| Regulatory policies |
Reimbursement models can limit list prices or incentivize discounts. |
| Clinical guidelines |
Inclusion of Ocrelizumab as a first-line therapy can sustain its premium pricing. |
| Market penetration |
Expanded use in under-served populations may stabilize revenues. |
Conclusion
Ocrelizumab (NDC 62135-0493) commands a premium price in the MS therapy segment, with a current annual treatment price around USD 75,000–USD 85,000 in the U.S. Market growth remains steady, driven by its approved indications and robust efficacy profile. The entry of biosimilars post-2028 is expected to depress prices, but the extent depends on regulatory and market dynamics.
Key Takeaways
- Ocrelizumab is a leading MS therapy with an approximate annual U.S. price of USD 75,000–USD 85,000.
- The total global MS drug market is USD 24 billion, with Ocrelizumab holding a large share, especially in the high-efficacy segment.
- Patent expiration around 2027–2028 may enable biosimilar entries, potentially reducing prices by 20–40%.
- Pricing strategies are influenced by healthcare reimbursement policies, clinical guidelines, and market competition.
- Current growth prospects remain positive, supported by increasing MS prevalence and clinical adoption.
FAQs
1. What is the primary indication for NDC 62135-0493?
It is used to treat relapsing multiple sclerosis and primary progressive multiple sclerosis.
2. How does the price of Ocrelizumab compare to other MS drugs?
Ocrelizumab’s annual cost is generally similar or higher than injectable therapies but lower than some newer, combination treatments.
3. When are biosimilars expected to enter the market?
Biosimilars may enter post-patent expiration, projected around 2027–2028.
4. How are pricing policies impacted by healthcare systems?
Reimbursement models, negotiations, and national policies influence the final cost paid by payers and patients.
5. Will the demand for Ocrelizumab decrease after biosimilar approval?
Initial demand may remain stable due to clinical preferences and proven efficacy; however, price reductions could impact overall prescribing patterns.
Sources
- IQVIA, "Global MS Market Analysis," 2022.
- FDA, "Ocrelizumab (Ocrevus) Approval Documentation," 2017.
- EvaluatePharma, "MS Drug Market Forecast," 2022.
- Centers for Medicare & Medicaid Services, "Reimbursement Policies," 2022.
- Generic Biosimilars Market Report, 2022.
