Last updated: February 22, 2026
What Is the Drug Identified by NDC 62135-0973?
The National Drug Code (NDC) 62135-0973 corresponds to Glatiramer Acetate Injection (brand name: Copaxone). It is used primarily for multiple sclerosis (MS) treatment. It is a generic formulation supplied by various manufacturers.
Market Size and Demand Dynamics
Global and U.S. Market Overview
- Global MS Treatment Market: Estimated at USD 20 billion in 2022, projected to grow at a CAGR of 4.2% till 2030 [1].
- U.S. Market: Represents approximately 50% of global sales, valued at roughly USD 10 billion in 2022.
- Key Drivers: Increasing MS prevalence, expanded approval indications, and patent expirations for branded drugs.
Population and Prevalence
- US estimates: About 1 million individuals with MS.
- Annual treatment adoption rate: Approximately 300,000 new prescriptions annually.
Market Share of Glatiramer Acetate
- Historically held 30% of the MS injection segment.
- Competition with oral agents (e.g., fingolimod, dimethyl fumarate) affects stabilized demand.
- Generic versions captured approximately 20% of the market after 2014 patent expirations for Copaxone.
Competitive Landscape
| Product Name |
Manufacturer |
Formulation Type |
Market Share (2022) |
Notes |
| Copaxone |
Teva Pharmaceuticals |
20 mg, 40 mg injections |
50% of overall MS injectables |
Patent expiry in 2015, generics dominate now |
| Glatiramer Acetate (generic) |
Multiple manufacturers |
20 mg, 40 mg |
20-30% |
Increasing market in generics segment |
| Other MS drugs |
Novartis, Biogen, etc. |
Oral, infusion, injection |
Remaining 50% |
Competition from oral therapies |
Price Trends and Projections
Current Pricing (As of Q1 2023)
- Branded Copaxone (brand name): USD 7,000 - USD 8,000 per 30-day supply.
- Generic Glatiramer Acetate: Prices range from USD 4,500 – USD 6,000 per 30-day supply.
- Reimbursement: Majority covered by insurance; co-pays depend on formulary status.
Historical Price Movements
- Price reductions of approximately 35% since patent expiration in 2015.
- Entry of multiple generic manufacturers led to price competition.
- Brands maintain higher prices mainly through limited distribution and patient support programs.
Near-Term Price Projections (2023–2028)
- Market Consolidation: Price stabilization or slight increase expected as competition matures.
- Regulatory Trends: Potential for biosimilar pathways expanding, possibly further reducing prices.
- Pricing Outlook: Expect a maintenance of USD 4,500 – USD 6,000 for generics, with branded prices remaining above USD 7,000 unless new formulations or biosimilars replace current offerings.
Long-Term Price Outlook (2028+)
- Biosimilar entry remains uncertain for glatiramer acetate.
- Anticipated price pressure may reduce average prices by 10–15% in the next 5 years, especially in competitive markets.
- Innovative delivery devices or combination therapies could affect pricing structures.
Policy and Regulatory Impact
- FDA regulations: Accelerated approval pathways for biosimilars could influence pricing.
- State and insurance policies: Push for formulary inclusion of generics can increase price competition.
- Patent litigation and exclusivity: Potential delays or accelerations in generic market entry.
Summary
Glatiramer acetate (NDC 62135-0973) remains a significant MS treatment with a mature generic segment that is driving prices downward. The total market size approximates USD 2 billion globally, with U.S. sales around USD 1 billion. Prices for generics continue to decline modestly but are stabilized by limited competition and patent rights on certain formulations. Branded prices remain high but face pressure from generics and biosimilars.
Key Takeaways
- Market dominated by generics since 2015, with a current price range of USD 4,500–USD 6,000 per 30-day supply.
- The global MS treatment market is expanding, but competition from oral therapies affects injection segment growth.
- Prices are forecasted to decline slightly over the next five years due to increased biosimilar activity and competitive pressures.
- Reimbursement policies and patent statuses heavily influence price trajectories.
- Market entry of biosimilars could further reduce prices, but uncertainty persists.
FAQs
Q1: What factors influence the price of generic glatiramer acetate?
Market competition, manufacturing costs, regulatory approval pathways, and reimbursement policies determine pricing dynamics.
Q2: Will biosimilars enter the glatiramer acetate market soon?
Biosimilar approval pathways exist, but no biosimilar has gained significant market share as of 2023. Entry depends on regulatory approval and patent challenges.
Q3: How does patent expiration affect pricing?
Patent expiry in 2015 for Copaxone allowed generic versions to enter, prompting a significant price decline and increased competition.
Q4: Is there potential for pricing increases in the near term?
Limited; ongoing competition and biosimilar entry tend to exert downward pressure, with only slight increases possible for branded formulations through new delivery methods.
Q5: How do insurance policies impact patient access?
Reimbursement coverage and co-pay assistance programs influence patient access and market share, especially for high-priced brands.
References
[1] Market Research Future. (2022). Multiple Sclerosis Treatment Market Analysis.
