Last updated: February 15, 2026
Overview of the Drug
NDC 10631-0009 is a generic formulation of glatiramer acetate, commonly marketed as Copaxone by Teva Pharmaceuticals. It is approved for the treatment of multiple sclerosis (MS). The drug's primary indication covers relapsing forms of MS, functioning as an immunomodulator that reduces relapse rates.
Market Size and Dynamics
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Global Multiple Sclerosis Market
- The global MS market was valued at approximately $22.7 billion in 2022.
- Expected compound annual growth rate (CAGR) from 2023 to 2030 is around 4.5% (Source: Grand View Research).
- The U.S. accounts for roughly 50% of the global MS market, driven by early diagnosis, advanced healthcare infrastructure, and higher drug prices.
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Market Penetration of Generic Glatiramer Acetate
- The original branded product, Copaxone, held a dominant share of the MS treatment market for years.
- Patent expiry in 2015 opened the market to generics.
- Multiple generic manufacturers, including those selling NDC 10631-0009, entered the market with competitive pricing.
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Sales Data and Market Share
- In 2022, the U.S. MS drug market generated approximately $12 billion.
- Generic glatiramer acetate accounts for a significant portion post patent expiry, with generic competition capturing an estimated 40-50% of the volume.
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Pricing Trends
- Branded Copaxone: List prices ranged from $65,000 to $70,000 annually per patient.
- Generics: Prices declined sharply after market entry, averaging $20,000–$30,000 annually, representing substantial savings for payers.
Pricing Analysis
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Current Price Range
- As of 2023, the average wholesale acquisition cost (AWAC) for NDC 10631-0009 ranges between $10,000 and $15,000 per 30-day supply, depending on distributor agreements and geographic location.
- Patients with insurance plans typically face negotiated prices lower than the AWAC, often in the $8,000–$12,000 range.
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Factors Influencing Price
- Manufacturing costs for generics are significantly lower than branded drugs, supporting lower prices.
- Market competition among multiple generic manufacturers leads to price compression.
- Payer policies and formulary placements heavily influence actual drug costs for patients.
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Price Projections
- Short-term (next 12 months): Prices may stabilize around current levels barring regulatory or supply chain disruptions.
- Medium-term (1–3 years): Expected gradual decline in prices to approximately $8,000–$12,000 annually due to ongoing competition.
- Long-term (beyond 3 years): Prices may decrease further to $5,000–$8,000 annually if more generics enter or biosimilar versions are approved.
Regulatory and Competitive Landscape
- Multiple generic suppliers have entered the market since 2015, including Mylan (now part of Viatris), Teva, and others.
- Patent litigation and legal challenges have slowed some biosimilar or follow-on formulations.
- The FDA has approved several biosimilar or similar products, which could influence future market dynamics.
Risks and Opportunities
- Patent litigation may delay new generic entrants.
- Supply chain stability impacts pricing.
- Expanding indications or new formulations could alter demand.
- Policy changes, such as increased biosimilar adoption, could pressure prices downward.
Key Takeaways
- NDC 10631-0009 is a generic glatiramer acetate used for MS.
- The drug's market faces intense competition, leading to lower prices than the branded product.
- Current prices hover around $8,000–$15,000 annually for payers.
- Prices are expected to decline further over the next 3 years, depending on market entry and regulatory factors.
- The overall MS drug market is valued at over $22 billion, with generics gaining increasing market share.
FAQs
Q1: How does the price of NDC 10631-0009 compare to the branded Copaxone?
A1: The generic typically costs 40-70% less, with annual prices around $8,000–$15,000 compared to branded Copaxone's $65,000–$70,000.
Q2: What factors could cause the price of NDC 10631-0009 to drop further?
A2: Increased generic competition, regulatory approvals of biosimilars, and payer formulary decisions.
Q3: Are supply shortages likely for this generic?
A3: Supply issues are possible but currently not pronounced; manufacturing scale and supply chain stability mitigate this risk.
Q4: What is the expected market share for this generic in the coming years?
A4: The generic could capture upward of 50% of glatiramer acetate sales, incrementally increasing as patent protections expire and brand sales decline.
Q5: How sensitive is the pricing to policy changes?
A5: Significant; policies favoring biosimilars and generic substitution can accelerate price decreases.
References
- Grand View Research. Multiple Sclerosis Market Size & Share Analysis, 2022–2030.
- IQVIA National Prescription Audit, 2022.
- FDA Drug Approvals, 2015–2023.
- Managing MS: Price Trends and Market Focus, 2023.
- Industry Reports on Generic Market Dynamics, 2023.
