Is There a Generic for Copaxone? Glatiramer Acetate Availability & Copay Assistance | QuickRx

If you or a loved one has been prescribed Copaxone (glatiramer acetate) for multiple sclerosis treatment, you may be wondering: Is there a generic Copaxone available? The good news is yes—generic glatiramer acetate has been available in the United States since 2015, providing patients with multiple options for their MS treatment.

At QuickRx Specialty Pharmacy, we help multiple sclerosis patients navigate their medication options and access Copaxone copay assistance programs that may reduce out-of-pocket costs—whether they’re taking brand Copaxone or generic glatiramer acetate.

This comprehensive guide answers all your questions about generic Copaxone, including when it became available, which manufacturers make it, whether it’s as effective as the brand, and how to access a Copaxone patient assistance program or glatiramer patient assistance program to help make treatment more affordable.

Is There a Generic for Copaxone?

Yes, generic Copaxone (glatiramer acetate) is available in the United States.

The U.S. Food and Drug Administration (FDA) has approved multiple generic versions of glatiramer acetate injection. The first generic, called Glatopa, was approved in April 2015. Since then, several additional manufacturers have received FDA approval to produce generic glatiramer acetate.

According to FDA approval records, generic glatiramer acetate is available in two strengths:

• 20 mg/mL – Administered once daily
• 40 mg/mL – Administered three times weekly (at least 48 hours apart)

Both strengths are therapeutically equivalent to brand-name Copaxone, meaning they contain the same active ingredient, work the same way in the body, and meet the same FDA quality and safety standards.

When Did Generic Copaxone Become Available?

Understanding the timeline of generic glatiramer acetate availability helps explain your options today. Here is the complete history of Copaxone and its generics:

Copaxone Patent and Generic History

• December 20, 1996: FDA originally approved brand Copaxone (glatiramer acetate) 20 mg/mL for multiple sclerosis treatment
• January 28, 2014: FDA approved Copaxone 40 mg/mL three-times-weekly formulation
• April 16, 2015: Glatopa (Sandoz) approved as the FIRST generic glatiramer acetate (20 mg/mL)
• October 3, 2017: Mylan approved for generic glatiramer acetate (both 20 mg/mL and 40 mg/mL)
• February 12, 2018: Glatopa 40 mg/mL (Sandoz) approved
• September 25, 2024: Synthon Pharmaceuticals approved (both strengths)
• May 7, 2025: Chemi SPA approved (both strengths)

Since 2015, the availability of generic glatiramer acetate has expanded significantly. Today, patients have multiple manufacturer options for both dosing regimens, which has helped increase access to this important MS treatment.

Who Makes Generic Glatiramer Acetate?

Several pharmaceutical companies manufacture FDA-approved generic glatiramer acetate. According to the FDA Orange Book, these include:

Generic Glatiramer Acetate 20 mg/mL Manufacturers:

• Sandoz (Glatopa) – Approved April 16, 2015
• Mylan – Approved October 3, 2017
• Synthon Pharmaceuticals – Approved September 25, 2024
• Chemi SPA – Approved May 7, 2025

Generic Glatiramer Acetate 40 mg/mL Manufacturers:

• Mylan – Approved October 3, 2017 (first generic at this strength)
• Sandoz (Glatopa) – Approved February 12, 2018
• Synthon Pharmaceuticals – Approved September 25, 2024
• Chemi SPA – Approved May 7, 2025

Your pharmacy will typically dispense whichever generic manufacturer they have in stock. All FDA-approved generic versions are therapeutically equivalent to brand Copaxone, so you can expect the same effectiveness regardless of which manufacturer’s product you receive.

Generic Glatiramer Acetate vs Brand Copaxone: Is It the Same?

Yes, generic glatiramer acetate is therapeutically equivalent to brand-name Copaxone.

The FDA requires generic medications to be bioequivalent to the brand-name drug. This means generic glatiramer acetate:

What’s the Same:

• Contains the same active ingredient (glatiramer acetate)
• Uses the same strength (20 mg/mL or 40 mg/mL)
• Works the same way in your body
• Has the same FDA-approved uses for relapsing forms of MS
• Follows the same dosing schedule
• Has the same safety profile and potential side effects
• Is rated “AP” (therapeutically equivalent) by the FDA

What May Be Different:

• The prefilled syringe or autoinjector device design
• Inactive ingredients (such as mannitol)
• Manufacturer and packaging
• Patient support programs offered by each manufacturer

Because generic glatiramer acetate is rated AP by the FDA, it can be substituted for brand Copaxone and is expected to have the same clinical effect and safety profile.

Glatopa vs Copaxone: What’s the Difference?

Glatopa is the brand name for Sandoz’s generic version of Copaxone. It was the first generic glatiramer acetate approved by the FDA and remains one of the most commonly prescribed generic options.

Key Points About Glatopa:

• Manufactured by Sandoz (a Novartis division) in the United States
• Available in both 20 mg/mL (daily) and 40 mg/mL (three times weekly) formulations
• FDA-approved as fully substitutable for Copaxone
• Developed in collaboration with Momenta Pharmaceuticals
• Comes with GlatopaCare patient support services

From a therapeutic standpoint, Glatopa and Copaxone are the same medication. The choice between them often depends on insurance coverage, pharmacy availability, and patient support program preferences. If you’re unsure which option is right for you, contact QuickRx Specialty Pharmacy to discuss your options.

Copaxone Copay Assistance & Patient Assistance Programs

Whether you’re taking brand-name Copaxone or generic glatiramer acetate, financial assistance may be available to help reduce your out-of-pocket costs. Specialty medications for multiple sclerosis can create significant expenses, but various Copaxone patient assistance programs and glatiramer patient assistance programs exist to help.

Types of Assistance That May Be Available:

• Manufacturer copay programs – Both brand and generic manufacturers may offer support for eligible patients with commercial insurance
• Patient assistance programs (PAPs) – For qualifying patients who meet certain criteria, including income requirements
• Foundation assistance – Nonprofit organizations that help with medication costs for MS patients
• Specialty pharmacy support – QuickRx helps identify and enroll patients in available programs

Manufacturer Support Programs:

• Shared Solutions (Teva) – Support program for brand Copaxone patients
• GlatopaCare (Sandoz) – Support services for Glatopa patients
• Mylan MS Advocate – Support program for Mylan generic glatiramer acetate patients

The specific programs you may qualify for depend on your insurance coverage and individual circumstances. Because eligibility requirements vary, it’s important to work with a specialty pharmacy that understands the landscape and can guide you to the right resources.

Important: Copay cards from one manufacturer typically do not apply to another manufacturer’s product. However, QuickRx can help you find the best assistance option regardless of which glatiramer acetate product you’re prescribed.

How QuickRx Helps You Access Copaxone or Glatiramer Acetate

At QuickRx Specialty Pharmacy, we help patients navigate the complex landscape of brand vs. generic options and Copaxone copay assistance programs. Our experienced team understands the challenges of affording specialty MS medications—and we’re here to help.

Our Team Will:

• Review your insurance coverage and medication options
• Identify Copaxone patient assistance programs or glatiramer patient assistance programs you may qualify for
• Handle enrollment paperwork and coordination on your behalf
• Arrange convenient home delivery of your medication
• Provide ongoing support and refill reminders to ensure no gaps in treatment

Getting started is easy: Call us at (917) 830-2525 or toll-free at (800) 496-6111, or fill out our online form. A pharmacy liaison will personally review your situation within one business day.

Learn more about our Copaxone copay assistance services and how we can help make your MS treatment more affordable.

Frequently Asked Questions About Generic Copaxone

References

1. U.S. Food and Drug Administration. FDA Approves First Generic Copaxone to Treat Multiple Sclerosis. April 16, 2015. https://www.fda.gov/
2. Drugs.com. Generic Copaxone Availability. https://www.drugs.com/availability/generic-copaxone.html. Accessed December 2025.
3. Sandoz. Sandoz Announces US FDA Approval and Launch of Glatopa. https://www.novartis.com/
4. Mylan. Mylan Announces U.S. FDA Approval of Generic Copaxone. October 3, 2017.
5. National Multiple Sclerosis Society. https://www.nationalmssociety.org/
6. Teva Neuroscience Inc. Copaxone (glatiramer acetate) Prescribing Information. January 2025.