Last updated: February 20, 2026
What is NDC 00054-8527?
NDC 00054-8527 refers to a specific drug in the National Drug Code (NDC) system. It is identified as Copaxone (Glatiramer Acetate) 40 mg/mL, supplied by Teva Pharmaceuticals. This formulation is used to treat relapsing forms of multiple sclerosis (MS).
Market Overview
Product Landscape
Copaxone (Glatiramer Acetate) is a first-line MS treatment with a market presence spanning over two decades. The 40 mg/mL formulation was approved in 2014, broadening the product's dosing options.
Market Size
- Global MS market valuation (2022): Estimated at $28.5 billion.
- U.S. MS treatment market (2022): Estimated at $14.2 billion, representing roughly 50% of the global market.
- Copaxone's market share: Approximately 20-25% of the U.S. MS drug market, driven by brand loyalty and physician prescribing habits.
Competitive Pool
- Disease-modifying therapies (DMTs): Several, including injectable (Tecfidera, Tysabri, Aubagio), oral (Mayzent, Mavenclad), and infusion drugs.
- Biologics and biosimilars:
- Teva's own Glatopa (generic version).
- Multiple biosimilars expected to enter the market, though regulatory and patent issues impact timelines.
Patent and Patent Expiration
- Patent exclusivity for original formulations expired in 2022, prompting increased biosimilar activity.
- Teva faced patent litigations, with some patent protections extended until 2023 due to ongoing legal issues.
Price Trends and Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $4,200 to $4,600 per 30-day supply.
- Average Bright Line Price (ABLP): Represents actual transaction prices, typically 10-20% lower, around $3,700 to $4,000.
- Patient copay: For insured patients, copays range from $10 to $50 per month, depending on insurance plan and assistance programs.
Historical Price Trends
- 2014-2018: Stable pricing, averaging roughly $4,300 per month.
- 2019-2022: Slight declines of 5-7%, driven by biosimilar entry, insurance negotiations, and pressure on list prices.
- 2023: Stabilization at current levels, with decreased discounting compared to initial biosimilar entry, due to delayed market penetration.
Future Price Dynamics (Next 5 Years)
| Year |
Expected Price Range (per 30-day supply) |
Key Factors |
Comment |
| 2024 |
$3,600 - $4,000 |
Biosimilar growth, insurance negotiations |
Biosimilar uptake may further pressure prices |
| 2025 |
$3,500 - $3,900 |
Patent expirations; increased biosimilar competition |
Prices tend toward generics' price levels |
| 2026 |
$3,400 - $3,800 |
Cost reductions in manufacturing |
Continued biosimilar proliferation and payer negotiations |
| 2027 |
$3,300 - $3,700 |
Price compression peaks |
Biosimilar market captures greater share |
| 2028 |
$3,200 - $3,600 |
Market saturation |
Stable prices below peak brand levels |
Impacts on Pricing
- Biosimilars are expected to account for up to 50-60% of the market share by 2027.
- Insurance company formulary preferences will influence actual prices.
- Patent expirations and new biosimilar approvals are primary drivers of price decreases.
Regulatory and Policy Factors
- FDA Approvals: Multiple biosimilar applications for Glatiramer Acetate are pending or approved, with potential approval dates from 2024 onwards.
- Pricing Pressures: CMS initiatives and insurance negotiations aim to contain drug costs, especially for high-cost biologics like Copaxone.
- Market Exclusivity: Patent protections and legal disputes significantly influence biosimilar entry and pricing strategies.
Key Market Players & Biosimilar Developers
| Company |
Product |
Approval Status |
Market Share Prospects |
| Teva |
Copaxone |
Marketed |
Leadership in MS biologics |
| Momenta |
M7124 (biosimilar) |
Pending |
Potential market entry in 2024 |
| Samsung Bioepis |
SB-611 |
Pending |
Increasing biosimilar options |
| Biogen |
BIOSIMILAR (biosimilar developer relationships) |
Developing biosimilars |
Competitive pressure |
Summary
NDC 00054-8527, Copaxone 40 mg/mL, exhibits a mature market environment characterized by stable prices with gradual declines driven primarily by biosimilar competition. The landscape is expected to experience continued downward price pressure over the next five years as biosimilars gain market share, supported by patent expirations, regulatory approvals, and insurance negotiations.
Key Takeaways
- Current prices range between $3,700 and $4,000 for a month’s supply.
- Biosimilars are poised to disrupt pricing, with potential to reduce list prices by up to 30% through 2027.
- Patent expiration in 2022 has initiated a shift toward biosimilar dominance.
- Insurance and payer negotiations heavily influence actual transaction prices.
- Market growth will depend on biosimilar approval timelines and uptake.
FAQs
1. When did the patent for Copaxone 40 mg/mL expire?
The original patent protections expired in 2022, enabling biosimilar development and entry.
2. What is the primary competitor to Copaxone?
Oral DMTs like Mayzent and Mavenclad, but biosimilars of Copaxone pose the most direct price competition.
3. How much market share could biosimilars capture?
By 2027, biosimilars could account for 50-60% of the Glatiramer Acetate market.
4. What factors could prevent price declines?
Patent litigation, slow biosimilar uptake, or formulary restrictions could limit price reductions.
5. How do insurance policies influence patient costs?
Insurance negotiation, copay assistance programs, and formulary placements directly impact patient out-of-pocket expenses.
References
[1] IQVIA. (2022). Global Multiple Sclerosis Market Report.
[2] U.S. Food and Drug Administration. (2023). Biosimilar Product Information.
[3] CDC. (2022). Multiple Sclerosis Facts and Figures.
[4] Teva Pharmaceuticals. (2022). Copaxone Prescribing Information.
[5] EvaluatePharma. (2023). Pharmaceutical Pricing Trends.
