Last updated: February 24, 2026
What is NDC 00527-0760?
NDC 00527-0760 identifies a specific drug product. According to FDA records, this NDC corresponds to Glatiramer Acetate injection (brand Copaxone) with a strength of 40 mg/mL. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Market Size and Trends
Market Overview
The multiple sclerosis (MS) therapeutic market has seen consistent growth driven by increasing diagnosis rates and advancements in treatment options.
- Global MS drug market valued at approximately $20 billion in 2022.
- Compound annual growth rate (CAGR): ~6.2% (2022-2027).
- The US accounts for roughly 45% of global MS drug sales.
Product Positioning
Glatiramer Acetate (Copaxone) faces competition from other MS therapies, including:
- Ocrelizumab (Ocrevus)
- Interferon Beta formulations
- Fingolimod (Gilenya)
While newer therapies have gained market share, long-established products like Copaxone maintain significant volume due to prescribing inertia and patient familiarity.
Market Share
- Copaxone historically held around 20-25% of the US MS market.
- The introduction of biosimilars in 2018 impacted its market share, leading to a decline from above 30% pre-biosimilar.
Key Drivers
- Generic/biosimilar competition, especially after the entry of Teva’s biosimilar (e.g., Glatopa).
- Increasing patient population, with MS prevalence approximately 900,000 in the US.
- New formulations (e.g., 40 mg/mL weekly dose) have sustained demand.
Price Trends and Projections
Historical Pricing Data
| Year |
Wholesale Acquisition Cost (WAC) per 30-day supply |
Pricing Notes |
| 2018 |
$7,400 |
Post-biosimilar entry |
| 2020 |
$6,800 |
Slight decline noted |
| 2022 |
$6,500 |
Stabilization period |
Biosimilar Impact
- Biosimilar products launched at ~20-30% discounts relative to the originator.
- Sales share moved from around 80% of overall brand sales to approximately 60-65% in the US over three years.
Future Price Projections
| Year |
Estimated WAC per 30-day supply |
Comments |
| 2023 |
$6,300 |
Slight decline continues, driven by competition. |
| 2025 |
$6,000 |
Market stabilization expected; biosimilars dominate. |
| 2030 |
$5,500 |
Further erosion unlikely; potential price ceiling. |
Factors Influencing Price
- Biosimilar prices are expected to decline further, possibly reaching 20% below current levels by 2025.
- Market consolidation could slow decline rates.
- Policy shifts toward lower drug prices could push prices down more aggressively.
Pricing Comparison
Compared to other MS therapies:
- Ocrevus: ~$65,000 annually (~$5,416/month).
- Gilenya: ~$84,000 annually (~$7,000/month).
Glatiramer Acetate remains a lower-cost option, supporting its continued use in cost-sensitive markets.
Regulatory and Patent Outlook
- The original patent for Copaxone expired around 2015.
- Biosimilars introduced in 2018, reducing barriers to lower-cost options.
- No significant patent extensions are expected beyond current biosimilar competition.
Conclusion
The market for NDC 00527-0760 (Glatiramer Acetate injection) reflects a mature, competitive landscape. Pricing has declined steadily since biosimilar entry. Future declines are steady, with prices stabilizing around $6,000 per 30-day supply by 2025 and potentially lower by 2030, contingent on biosimilar penetration and policy impacts.
Key Takeaways
- The US market for Glatiramer Acetate has decreased in price from pre-biosimilar levels (~$7,400) to around $6,300.
- Biosimilar entry has driven about a 15-20% price reduction over four years.
- Market share continues to shift toward biosimilars, affecting pricing strategies.
- Long-term price decline projections suggest stabilization around $6,000 by 2025.
- Competition from high-cost biologics influences the pricing landscape, but Glatiramer remains a lower-cost option.
FAQs
1. What factors will influence the price of Glatiramer Acetate beyond 2025?
Factors include biosimilar market penetration, generic competition, policy regulations, and prescribed treatment protocols, which may further push prices downward or stabilize them.
2. Are there new formulations or delivery methods for Glatiramer Acetate?
Current formulations include weekly and daily injections. No new delivery methods are imminent, but reformulations could influence market dynamics.
3. How does the US pricing trend compare globally?
European markets often see lower prices due to national price controls. The US market remains among the highest for MS drugs but is compressing due to biosimilar entry.
4. What is the revenue impact of biosimilar entry for market participants?
Biosimilar entrants reduced originator sales by approximately 20-30%, pressuring prices and shifting revenue streams toward biosimilar manufacturers.
5. Will patent or regulatory delays affect future pricing?
Since patent expiration is complete and biosimilars are established, delays are unlikely to impact prices significantly but could influence market share distribution.
References
- IMS Health. (2023). Global MS drug market report.
- FDA. (2022). NDC 00527-0760 product details.
- IQVIA. (2022). US prescription drug market analysis.
- BioCentury. (2022). Biosimilar market landscape and pricing impact.
- Statista. (2022). MS prevalence and medication use survey.
