CLINICAL TRIALS PROFILE FOR GLATIRAMER ACETATE

505(b)(2) Clinical Trials for GLATIRAMER ACETATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01578785 ↗	An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3	2012-03-01	This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
New Formulation	NCT01578785 ↗	An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)	Terminated	Teva Pharmaceutical Industries	Phase 3	2012-03-01	This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

All Clinical Trials for GLATIRAMER ACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039988 ↗	Treatment of Multiple Sclerosis With Copaxone and Albuterol	Completed	Autoimmunity Centers of Excellence	N/A	2001-11-01	The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
NCT00039988 ↗	Treatment of Multiple Sclerosis With Copaxone and Albuterol	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-11-01	The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
NCT00071838 ↗	Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2003-10-30	This study will examine the safety of Zenapax (daclizumab) in patients with multiple sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes (cells of the immune system), are thought to damage myelin, a substance that covers the nerve and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin that occurs in multiple sclerosis. Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this study. Patients with secondary-progressive or primary progressive MS may not participate. Candidates will be screened with a complete neurological and medical evaluation and review of medical records. Participants will undergo the following tests and procedures: - Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over a 3-month period to assess disease activity. For the MRI scans, the patient lies on a table that slides into the scanner - a narrow metal cylinder with a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Only patients with activity at or above a certain level are eligible to continue with the treatment phase of the study. - Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax. The first two infusions are 2 weeks apart, followed by 13 monthly infusions. - MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease activity and identify new brain lesions. - Blood and urine tests: Blood and urine samples are collected at each clinic visit for routine laboratory evaluations, immunologic study, and genetic testing to determine a predisposition for responding to Zenapax treatment. - Lumbar puncture (spinal tap): This procedure will be done during the last month before starting treatment and during the seventh month of treatment to examine immune changes that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the brain and spinal cord. A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. - Skin test: A needle is placed just under the skin is done to assess the patient's immune status to common antigens such as tetanus, mumps and candida. - Lymphocytopheresis: Lymphocytes are collected three times - once during the last month of baseline before starting treatment, once during the fifth month of treatment, and once during the last month of treatment - for immunologic study. Blood is collected through a needle in an arm vein in a similar way to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The lymphocytes are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body, either through the same needle or through another needle in the other arm.

Clinical Trial Conditions for GLATIRAMER ACETATE

Condition Name

Condition Name for GLATIRAMER ACETATE
Intervention	Trials
Multiple Sclerosis	28
Relapsing Remitting Multiple Sclerosis	15
Relapsing-Remitting Multiple Sclerosis	13

Condition MeSH

Condition MeSH for GLATIRAMER ACETATE
Intervention	Trials
Multiple Sclerosis	71
Sclerosis	68
Multiple Sclerosis, Relapsing-Remitting	47

Clinical Trial Locations for GLATIRAMER ACETATE

Trials by Country

Trials by Country for GLATIRAMER ACETATE
Location	Trials
United States	424
Germany	33
Canada	33
Spain	30
Brazil	16

Trials by US State

Trials by US State for GLATIRAMER ACETATE
Location	Trials
California	22
New York	20
Ohio	19
Illinois	17
Florida	17

Clinical Trial Progress for GLATIRAMER ACETATE

Clinical Trial Phase

Clinical Trial Phase for GLATIRAMER ACETATE
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	21
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for GLATIRAMER ACETATE
Clinical Trial Phase	Trials
Completed	48
Terminated	10
Unknown status	6

Clinical Trial Sponsors for GLATIRAMER ACETATE

Sponsor Name

Sponsor Name for GLATIRAMER ACETATE
Sponsor	Trials
Teva Pharmaceutical Industries	19
Teva Branded Pharmaceutical Products R&D, Inc.	16
Biogen	9

Sponsor Type

Sponsor Type for GLATIRAMER ACETATE
Sponsor	Trials
Other	87
Industry	79
NIH	8

Glatiramer Acetate Clinical Trials Update, Market Analysis and Exclusivity Timeline: Copaxone and Generic/Biosimilar Risks

Last updated: July 27, 2026

Glatiramer acetate remains a long-established MS therapy with ongoing clinical activity focused on comparative effectiveness, tolerability, adherence, and expansion studies in broader MS subtypes. Market growth is constrained by aging use patterns and pricing pressure from multisource competition. The exclusivity and patent landscape is primarily driven by the original Copaxone (and related manufacturing and formulation patents) and by the entry history of approved generic glatiramer acetate products in the US.

What is the current clinical trials landscape for glatiramer acetate in multiple sclerosis?

Clinical trial activity for glatiramer acetate in MS is concentrated in three themes: (1) comparative dosing/regimens, (2) safety and tolerability in routine or pragmatic populations, and (3) outcomes in specific MS phenotypes (relapsing disease spectrum) using endpoints aligned with NEDA, relapse rate, MRI lesion burden, and patient-reported outcomes.

Which trial types are most common for glatiramer acetate

• Randomized comparative or add-on studies versus other platform therapies (timing differs by sponsor; endpoints tend to include relapse rate and MRI measures).
• Real-world or pragmatic prospective cohorts measuring injection-site reactions, adherence, persistence, and discontinuation.
• Studies addressing dosing frequency changes or adherence-support interventions (intended to reduce treatment discontinuation from injection burden).

What endpoints sponsors typically use

• Annualized relapse rate (ARR)
• MRI gadolinium-enhancing lesions and T2 lesion counts
• Time to first relapse
• Disability progression proxies (trial design varies)
• Patient-reported outcomes for injection-site pain and overall treatment satisfaction

Where clinical evidence is concentrated

• Relapsing-remitting MS (RRMS) is the dominant target population for efficacy and safety comparisons.
• Secondary progressive MS trials exist historically; ongoing work tends to emphasize relapsing components or early disease phases due to trial power and endpoint sensitivity.

How does glatiramer acetate perform versus other MS disease-modifying therapies?

Glatiramer acetate competes in the “lower-efficacy ceiling, favorable long safety profile” segment of the MS market. Compared with higher-efficacy agents (notably B-cell depleters and some oral therapies), glatiramer’s relative effectiveness is generally lower on relapse and MRI suppression, but it is positioned for tolerability and long-term use.

What comparative analyses generally show

• Versus interferon beta products, glatiramer acetate often shows broadly comparable ARR and MRI efficacy, with differences in specific safety profiles (injection-site reactions versus flu-like symptoms).
• Versus natalizumab, fingolimod, ocrelizumab, and other high-efficacy classes, glatiramer typically underperforms on MRI lesion suppression in head-to-head designs or indirect comparisons, though it can be similar in selected subgroups depending on trial era and patient selection.

What drives treatment selection in practice

• Injection-site reactions are a key driver of adherence and discontinuation risk.
• Preference for long-established safety data and clinician comfort influences uptake.
• Switching patterns reflect risk tolerance, pregnancy planning, and comorbidity considerations.

What is the Orange Book status of glatiramer acetate products in the US?

The US exclusivity profile for glatiramer acetate is determined by the Orange Book listing for glatiramer acetate drug products and by patents covering the active ingredient manufacturing, formulation, and method-of-use. Glatiramer acetate is a long-commercialized product with multiple approved multisource equivalents.

Featured snippet answer

Glatiramer acetate has multiple FDA-approved products in the US market, and Orange Book coverage typically reflects a combination of legacy composition, formulation, and method patents rather than broad, single “blockbuster-style” exclusivity.

What to expect in Orange Book coverage

• Composition or salt/form related patents for the active drug substance
• Formulation patents linked to specific container closure, concentrations, and excipient packages
• Method-of-use or therapeutic regimen patents where present
• Manufacturing process patents, including steps that support controls and consistency

When does glatiramer acetate lose exclusivity and what timelines matter for generic competition?

For drug assets with long-standing commercial presence, the key question is not a single exclusivity date but the timing of patent expirations that block approval pathways or trigger settlement leverage.

What timelines matter in practice

1. Patent expiration for Orange Book-listed patents tied to drug product or manufacturing.
2. Regulatory exclusivity (if any) that blocks generic approval or conversion to AB-rated equivalents.
3. Paragraph IV litigation triggers (where challenges were filed) and subsequent settlement dates.

Featured snippet answer

Glatiramer acetate’s exclusivity has largely been worked down through legacy patent expirations and prior generic entries, leaving remaining leverage primarily in formulation or manufacturing-adjacent patents that are narrower and product-specific.

How many patents cover glatiramer acetate and who holds the patent estate?

The patent estate for glatiramer acetate is distributed across assignees for different aspects of the product: the original innovator and related manufacturing/formulation holders. The breadth of coverage depends on whether you count (a) substance patents, (b) formulation and device-related patents, and (c) manufacturing process claims.

Common patent categories in glatiramer acetates

• Active ingredient composition and related structural or preparation claims
• Drug product formulation claims (concentration, excipients, particle size or stability controls)
• Method-of-use claims (historical and sometimes narrow)
• Manufacturing methods including controlled synthesis and purification steps

What matters for freedom-to-operate

• Whether remaining enforceable patents are product-specific (container or concentration)
• Whether process patents create manufacturing design-around barriers
• Whether any method-of-use claims remain in force for MS treatment regimens that a generic must avoid in labeling or instructions

What patent litigation affects glatiramer acetate generics and biosimilar entry risk?

Glatiramer acetate is a chemical drug, not a biologic. That means “biosimilar” risk is not the correct frame. Instead, the litigation risk is about generic approvals and Paragraph IV patent challenges tied to the Orange Book.

Featured snippet answer

Glatiramer acetate’s litigation exposure is driven by Paragraph IV challenges and enforcement of patents related to drug product formulation or manufacturing, not biosimilar pathways.

Do settlement agreements change the generic launch calendar for glatiramer acetate?

Settlements can delay market entry, convert disputes into licensing arrangements, or fix launch dates with supply commitments. For legacy products, settlement effects typically show up as:

• Delayed generic launches relative to the earliest “approval-ready” posture.
• Entry only into specific strengths or packaging configurations.
• Retail and payer channel timing differences.

What to monitor commercially after settlements

• Segment-by-segment penetration: specialty pharmacy distribution for MS is sensitive to plan formularies.
• Switching behavior: payer incentives can accelerate switches even after an initial delay.

What formulations of glatiramer acetate are on the market and what are the differentiation points?

Glatiramer acetate products are differentiated by concentration, strength, and packaging format, with consistent core injection administration. Market competition often hinges on:

• Price per unit and patient copay design
• Availability through specialty pharmacies
• Substitution rules under pharmacy benefit designs
• Stability and shelf-life, which can affect contracting

Key commercial differentiation points

• Concentration and dosing regimen presented on the label
• Device and packaging compatibility for injection workflow
• Stability and distribution constraints in cold-chain adjacent systems (if applicable to a given product presentation)

Market analysis: How big is the glatiramer acetate market and what drives near-term demand?

Glatiramer acetate sits in a mature MS therapy market with supply expansion by multisource competition. Demand is driven by:

• Ongoing incident prevalence in RRMS and treatment-naïve patients
• Switching from other injectables due to safety profile and patient tolerance
• Stability in payer preference for lower-cost platform therapies after generic entry

Demand drivers

• Patient persistence: injection burden influences discontinuation.
• Safety profile: long historical use supports clinician comfort and patient willingness.
• Real-world outcomes: adherence and injection-site tolerability often determine continued use.

Constraints

• Pricing compression after generic launches and payer formulary tightening.
• Competition from higher-efficacy or oral therapies that reduce injection frequency.

Market projection: What is the revenue outlook for glatiramer acetate through 2030?

A credible projection for glatiramer acetate requires tying:

• New patient starts
• Persistence and switch rates
• Unit pricing trends under generic competition
• Share drift toward oral and infusion therapies
• International variability (pricing and reimbursement structures differ materially by region)

Projection structure (business model logic)

1. Units: driven by RRMS treated population and persistence.
2. Net price: driven by generic competition and rebating intensity.
3. Share: influenced by MS therapy migration toward oral and high-efficacy classes.
4. Exits: discontinuation driven by injection-site reactions and evolving treatment guidelines.

Featured snippet answer

Through 2030, glatiramer acetate revenue is expected to be flat-to-declining in markets where generic competition is mature, with modest volume resilience offset by sustained net price erosion and share shift to newer MS mechanisms.

How does glatiramer acetate compare with high-efficacy MS therapies on value and payer acceptance?

Payers tend to accept glatiramer acetate when:

• Member access to high-cost therapies is restricted by step-edits or prior authorization
• Formulary committees want a reliable platform for low-to-moderate disease activity
• Budget impact models prioritize generics or low net cost injectables

Value proposition framing used in procurement

• Lower annual acquisition cost versus high-efficacy injectables/orals
• Long safety data supporting low-risk treatment choices
• Manageable adverse event burden relative to certain alternatives

What generic entry risks exist for glatiramer acetate?

Generic entry risk is about manufacturing readiness and regulatory compatibility rather than biosimilar-level complexity. Key risks include:

• Patent barriers for product formulations and manufacturing processes
• Supply chain constraints and batch release controls for injectable sterile products
• Contracting and pharmacy network lock-in, which can take time to overcome even after approval

Featured snippet answer

The entry risk is primarily incremental post-approval: even when regulatory approval is achieved, market share shifts depend on pricing, distribution, and payer acceptance.

What manufacturing and IP barriers can block or slow glatiramer acetate generic substitution?

Manufacturing is a practical barrier in sterile injectables and complex polypeptide mixtures where consistency and stability matter. IP barriers remain relevant when claims cover:

• Specific purification or synthesis steps
• Particle size or molecular weight distribution control
• Formulation stability parameters linked to shelf life and storage

Key companies and competitive landscape for glatiramer acetate

Glatiramer acetate competition includes the original brand and multiple generic manufacturers. The competitive environment is shaped by:

• FDA-approved product availability by strength and presentation
• Specialty pharmacy contracting strength
• Payer formulary placement and automatic substitution rules

How competitors typically compete

• Acquisition cost and rebate strategy
• Contracted distribution breadth
• Patient support programs and nurse education for injections

Key Takeaways

• Glatiramer acetate’s clinical evidence base remains anchored in RRMS and long-term tolerability, with ongoing trial work focused on comparative effectiveness, adherence, and patient-centered outcomes.
• The US market is mature with sustained multisource competition, pushing projections toward flat-to-declining revenue in mature geographies due to net price compression.
• Patent leverage is concentrated in narrower areas tied to formulations and manufacturing, with exclusivity largely worked down after legacy entries.
• Competitive outcomes depend on unit pricing, persistence, payer placement, and distribution rather than single-step regulatory events.

FAQs

1. What are the most common adverse events leading to discontinuation with glatiramer acetate?
2. How do injection-site reactions affect persistence and switching for glatiramer acetate in real-world MS care?
3. Which MRI endpoints are most frequently used to compare glatiramer acetate with other MS therapies?
4. Do generic glatiramer acetate products differ meaningfully in stability, shelf life, or device presentation?
5. How do step-edit payer policies influence access to glatiramer acetate versus oral or infusion MS therapies?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA website.
2. ClinicalTrials.gov. Search results for “glatiramer acetate” and “multiple sclerosis” (accessed 2026-07-27).