Last updated: March 21, 2026
What is NDC 43598-0605?
NDC 43598-0605 identifies a specific drug product. Based on available data, it corresponds to Glatiramer Acetate (brand name: Copaxone), used in multiple sclerosis treatment. The formulation is a 20 mg/mL pre-filled syringe, supplied by Teva Pharmaceuticals.
Market Size and Demand Dynamics
Prescriber Base
- Multiple sclerosis (MS) affects approximately 2.8 million people globally, with the U.S. accounting for roughly 1 million patients.
- MS treatment market is dominated by immunomodulatory drugs, of which Glatiramer Acetate captures about 10–15% in the U.S., translating to a sizable patient population requiring therapy.
Market Trends
- Growth rate of the MS drug market averages 4–6% annually.
- Biologics and biosimilars entering the market threaten traditional drugs, but Glatiramer remains relevant due to its established efficacy profile.
- The drug is often preferred by patients intolerant to other therapies due to its safety profile.
Competitive Landscape
| Drug Name |
Market Share |
Key Features |
Pricing (per 20 mg pre-filled syringe) |
| Glatiramer Acetate (Copaxone) |
~60% |
Long-standing, well tolerated |
$3,000–$3,500 |
| Interferon beta products |
~25% |
Multiple formulations |
$2,500–$4,000 |
| Oral MS agents |
~15% |
Convenience, newer |
$5,000–$8,000 annually |
- Biosimilar entry exists, but is limited in scope and approval status.
Price Trends and Future Projections
Historical Price Data
- 2010–2020: Average wholesale prices for a 20 mg syringe ranged from $2,500 to $3,500.
- Post-2020: Slight upward trend; prices increased in line with inflation and increased manufacturing costs, reaching approximately $3,200–$3,500.
Factors Impacting Price
- Market exclusivity: Patent protections and exclusivity periods influence price stability.
- Biosimilar competition: Approval and adoption may pressure prices downward.
- Regulatory Decisions: FDA and CMS policies targeting drug pricing and formulary placement will influence future prices.
Price Projections (Next 5 Years)
| Year |
Estimated Wholesale Price (per syringe) |
Key Drivers |
| 2023 |
$3,250 |
Stable demand, patent protection remains |
| 2024 |
$3,200–$3,300 |
Biosimilar entry increases competition |
| 2025 |
$3,100–$3,200 |
Biosimilar adoption accelerates |
| 2026 |
$3,000–$3,150 |
Market saturation, price stabilization |
| 2027 |
~$3,000 |
Limited further decline without regulatory change |
Impact of Biosimilar Entry
- Limited biosimilar approval exists as of 2023, but market introduction may reduce price by 10–15% over the next 2–3 years.
- Price erosion may stabilize around $3,000 per syringe by 2027.
Revenue Implications
- Annual sales volume in the U.S. estimated at 1.2–1.5 million syringes.
- Total market value approximates $3.6–$5.25 billion annually, depending on volume and price fluctuations.
Regulatory and Policy Risks
- Actions by CMS or FDA targeting drug pricing could further impact revenue.
- Approved biosimilars from competitors may result in sustained price pressure.
- Patent litigations or extensions could delay biosimilar market entry.
Key Takeaways
- NDC 43598-0605 (Glatiramer Acetate) maintains a stable market with moderate growth.
- The current wholesale price ranges between $3,200 and $3,500 per syringe.
- Biosimilar competition exists but has yet to significantly impact pricing.
- Price projection indicates a gradual decline to approximately $3,000 by 2027.
- Revenue depends heavily on prescriber and patient uptake, with significant exposure to biosimilar entries.
FAQs
1. How does biosimilar competition impact the price of Glatiramer Acetate?
Biosimilars are expected to lower prices by 10–15% within 2–3 years of introduction, though the impact depends on market adoption and formulary preferences.
2. Is the current patent status relevant to future pricing?
Yes. Patents and exclusivity periods delay biosimilar entry; their expiration typically leads to price reductions.
3. What are the primary factors driving demand?
Demand is driven by the prevalence of MS, prescriber habits, and patient tolerance, with stability seen due to long-standing safety profiles.
4. What is the average wholesale price trend for Glatiramer Acetate?
Prices increased modestly from $2,500 to about $3,500 (2010–2020), with current levels around $3,200–$3,500.
5. How might regulatory changes influence future prices?
Policies aimed at controlling drug costs, promoting biosimilar use, or altering reimbursement may accelerate price declines or stabilize prices at lower levels.
References
- FDA. (2023). Biosimilar Guidance. U.S. Food and Drug Administration.
- IQVIA. (2022). The US Pharmaceutical Market Primer.
- CDC. (2023). Multiple Sclerosis Data. Centers for Disease Control and Prevention.
- Medicare.gov. (2023). Part B & Part D Drug Pricing.
- Teva Pharmaceuticals. (2022). Copaxone (Glatiramer Acetate) Product Details.
[1] U.S. Food and Drug Administration. (2023). Biosimilar Guidance.
[2] IQVIA. (2022). The US Pharmaceutical Market Primer.
[3] Centers for Disease Control and Prevention. (2023). Multiple Sclerosis Data.
[4] Medicare.gov. (2023). Part B & Part D Drug Pricing.
[5] Teva Pharmaceuticals. (2022). Copaxone Product Details.
