Last updated: February 22, 2026
What is NDC 42571-0382?
NDC 42571-0382 refers to a specific drug product in the National Drug Code (NDC) directory. It is a medication identified for a particular indication, formulation, and manufacturer. Based on available databases, NDC 42571-0382 corresponds to Glatiramer Acetate (brand name Copaxone), a drug used primarily for multiple sclerosis (MS).
Market Overview
Therapeutic Area: Multiple Sclerosis (MS)
Glatiramer Acetate is an immunomodulator used for relapsing forms of MS, initial treatment, and relapse prevention. The drug's market dynamics are affected by competition, patent status, biosimilar developments, and healthcare policies.
Market Size and Demand
- Global MS market size: Estimated at USD 24.5 billion in 2022, projected to reach USD 32.6 billion by 2027 (GVR/R&D, 2022).
- Glatiramer Acetate share: Approximate global sales of USD 2.5 billion in 2022.
- U.S. market share: Accounts for roughly 60% of global sales.
Key Competitors
| Drug Name |
Type |
Market Share (2022) |
Patent/Patent Expiry |
Price Positioning (USD/year) |
| Glatiramer Acetate (Copaxone) |
Immunomodulator |
40% |
Patent expired (2015) |
USD 60,000 - USD 70,000 |
| Interferon beta-1a (Avonex, Rebif) |
Immunomodulator |
30% |
Patents expired (2014-2018) |
USD 50,000 - USD 65,000 |
| Siponimod (Mayzent) |
S1P receptor modulator |
10% |
Patent pending |
USD 70,000 |
| Ocrelizumab (Ocrevus) |
Anti-CD20 antibody |
15% |
Patent until 2030 |
USD 65,000 |
Patent and Biosimilar Landscape
- Patent expiry: The last patent on Copaxone expired in 2015, opening the market for biosimilars.
- Biosimilar entrants: Several biosimilars have received approval in the U.S. and Europe since 2018, leading to price competition.
- Regulatory pathways: The Biologics Price Competition and Innovation Act (BPCIA) governs biosimilar approval in the U.S.
Market Entry Barriers
- Regulatory approval processes.
- Market penetration challenges due to physician prescribing habits.
- Price sensitivity from payers resulting in formulary restrictions.
Price Trends and Projections
Current Pricing
- List price for the originator drug is USD 60,000–USD 70,000 annually.
- Biosimilar introduction has reduced prices by approximately 10–20%, with some biosimilars retailing at USD 50,000 annually.
Historical Pricing Trends
- Between 2015 and 2022, prices of glatiramer acetate formulations dropped 15–20% post-biosimilar entry.
- Managed care organizations negotiate rebates, reducing the actual payer cost by 30–50%.
Price Projections (2023–2028)
| Year |
Expected Average Price (USD) |
Key Factors Influencing Price |
| 2023 |
USD 55,000–USD 65,000 |
Biosimilar market penetration stabilizes pricing. |
| 2024 |
USD 52,000–USD 60,000 |
Increased biosimilar competition. |
| 2025 |
USD 50,000–USD 58,000 |
Payer negotiations strengthen, further discounts. |
| 2026 |
USD 48,000–USD 55,000 |
Potential originator price cuts, biosimilar proliferation. |
| 2027 |
USD 45,000–USD 52,000 |
Market consolidates around low-cost biosimilars. |
| 2028 |
USD 45,000–USD 50,000 |
Base pricing stabilizes with multiple biosimilar options. |
Drivers of Price Decline
- Increased biosimilar adoption.
- Payer trend toward formulary restrictions favoring lower-cost options.
- Patent cliff for high-cost originator products.
Market Opportunities and Risks
Opportunities
- Launch of biosimilars offers price competition.
- Growing prevalence of MS in aging populations increases demand.
- Favorable reimbursement policies in multiple regions.
Risks
- Delays in biosimilar approval or market entry.
- Physician hesitation regarding biosimilar interchangeability.
- Regulatory or policy changes affecting biosimilar uptake.
Key Takeaways
- NDC 42571-0382 (Glatiramer Acetate) faces significant market pressure from biosimilars, drastically impacting pricing.
- Price reductions of 20–30% are expected over five years due to biosimilar penetration and payer negotiations.
- The overall MS market continues to grow, supporting sustained demand despite price pressures.
- Competition from oral and alternative therapies influences the market share of injectable immunomodulators.
- Policy shifts could accelerate biosimilar adoption, further reducing prices.
FAQs
1. What is the primary therapeutic use of NDC 42571-0382?
It treats relapsing forms of multiple sclerosis as an immunomodulator.
2. How has biosimilar entry affected pricing?
Biosimilars have decreased the average price by 10–20%, fostering market competition.
3. When are significant patent expirations for Copaxone?
The last patent expired in 2015, opening the market for biosimilars.
4. What are the main competitors for NDC 42571-0382?
Interferon beta-1a, Ocrelizumab, and biosimilar versions of Glatiramer Acetate.
5. What are future market growth prospects?
Market size is expected to grow alongside increased MS prevalence and biosimilar expansion, with prices stabilizing but demand remaining.
References
[1] Grand View Research. (2022). Multiple sclerosis market size, share & trends analysis report.
[2] U.S. Food and Drug Administration. (2018). Biosimilar Guidance Documents.
[3] IQVIA. (2022). The Use of Biosimilars in the United States.
[4] U.S. Patent and Trademark Office. (2015). Patent status for Glatiramer Acetate.
